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This study will integrate a technology-based patient-reported outcome (PRO) system [herein MJS DIABETES] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs.
Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration.
For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MJS DIABETES | Experimental | will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study. |
|
| Usual Care | No Intervention | Standard Diabetes Treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MJS Diabetes | Behavioral | patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Level at Baseline | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. | Baseline |
| HbA1c Level at Month 12 | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. |
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Inclusion Criteria:
Primary Care Provider Inclusion Criteria:
Patient Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoinette Schoenthaler, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36374531 | Derived | Mandal S, Belli HM, Cruz J, Mann D, Schoenthaler A. Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study. JMIR Diabetes. 2022 Nov 14;7(4):e41140. doi: 10.2196/41140. | |
| 32865505 | Derived | Schoenthaler A, Cruz J, Payano L, Rosado M, Labbe K, Johnson C, Gonzalez J, Patxot M, Patel S, Leven E, Mann D. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study. JMIR Form Res. 2020 Aug 31;4(8):e18554. doi: 10.2196/18554. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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N= 246 participants were enrolled, N=9 of these participants were not randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | MJS DIABETES | MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs. |
| FG001 | Usual Care | Standard Diabetes Treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MJS DIABETES | MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c Level at Baseline | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. | Posted | Mean | 95% Confidence Interval | Percentage of total hemoglobin | Baseline |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MJS DIABETES | will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study. MJS Diabetes: patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoinette M. Schoenthaler | NYU Langone Health | 646-501-3434 | Antoinette.Schoenthaler@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2021 | Jan 27, 2025 | Prot_SAP_000.pdf |
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| Baseline |
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Month 3 |
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Month 6 |
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Month 9 |
| Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Month 12 |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Baseline |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Month 3 |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Month 6 |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Month 9 |
| Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Month 12 |
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Baseline |
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Month 3 |
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Month 6 |
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Month 9 |
| Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Month 12 |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Baseline |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Month 3 |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Month 6 |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Month 9 |
| Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Month 12 |
| Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Baseline |
| Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Month 6 |
| Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Month 12 |
| Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Baseline |
| Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Month 3 |
| Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Month 6 |
| Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Month 9 |
| Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Month 12 |
| Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Baseline |
| Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Month 3 |
| Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Month 6 |
| Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Month 9 |
| Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Month 12 |
| Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Baseline |
| Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Month 3 |
| Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Month 6 |
| Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Month 9 |
| Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Month 12 |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Baseline |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Month 3 |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Month 6 |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Month 9 |
| Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Month 12 |
| New diagnosis |
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| Usual Care |
Standard Diabetes Treatment |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | HbA1c Level at Month 12 | Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation. | Posted | Mean | 95% Confidence Interval | Percentage of total hemoglobin | Month 12 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the blood-glucose testing subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent weekly blood-glucose testing. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score | The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the foot care subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate more frequent completion of foot care activities. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Michigan Diabetes Knowledge Scale Score | 20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Diabetes Self-Efficacy Scale Score | 12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Interpersonal Processes of Care Score Communication Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication). | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Interpersonal Processes of Care: Decision Making Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making). | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| Secondary | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Posted | Mean | Standard Deviation | score on a scale | Month 9 |
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| Secondary | Interpersonal Processes of Care: Inter-personal Style Subscale Score | 18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style). | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 0 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Usual Care | Standard Diabetes Treatment | 0 | 120 | 0 | 120 | 0 | 120 |
Not provided
Not provided
Not provided