Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK116715 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CareAvenue | Experimental | Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. |
|
| Guest Assistance Program | Active Comparator | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareAvenue | Behavioral | CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c as Measured by an HbA1c Machine | HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine | Systolic blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine in millimeters of mercury (e.g., 120 mm Hg). The change in systolic blood pressure from baseline to 12 months is reported here as secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Minal R Patel, PhD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467918 | Derived | Patel MR, Zhang G, Heisler M, Piette JD, Resnicow K, Choe HM, Shi X, Song P. A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes. J Gen Intern Med. 2024 Oct;39(13):2415-2424. doi: 10.1007/s11606-024-08708-8. Epub 2024 Mar 11. | |
| 31923472 | Derived | Patel MR, Heisler M, Piette JD, Resnicow K, Song PXK, Choe HM, Shi X, Tobi J, Smith A. Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial. Contemp Clin Trials. 2020 Feb;89:105933. doi: 10.1016/j.cct.2020.105933. Epub 2020 Jan 7. |
Not provided
Not provided
All of the individual participant data that underlie results in a publication, after de-identification.
Beginning 3 months and ending 5 years following article publication
The data will be made available to other researchers who provide a methodologically sound proposal and who have appropriate approvals from all relevant IRBs. The data will be shared for analyses to achieve aims in the approved proposal. Data will be shared through a secure FTP site through encryption protocols that allow secure uploading of files with data sharing limited to specific users. Select datasets will also be made available through the University of Michigan openICPSR Repository (http://www.icpsr.umich.edu/icpsrweb/deposit/index.jsp). Proposals should be directed to minalrp@umich.edu. To gain access, data requestors will need to sign a data access agreement.
Not provided
After screening eligible and consenting to participate, 67 participants either later changed their mind and declined to participate prior to starting data collection, were unreachable for baseline collection, or did not complete baseline in order to be randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CareAvenue (Intervention) | Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management. |
| FG001 | Guest Assistance Program (Control) | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CareAvenue (Intervention) | Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management. |
| 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 | Change in HbA1c as Measured by an HbA1c Machine | HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness, unable to obtain measurement, etc. | Posted | Mean | Standard Deviation | percentage of average glucose 3 months | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
Adverse events were collected over a 1 year time period (from completing study consent to completing final data collection).
Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CareAvenue (Intervention) | Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. CareAvenue: CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Non-Serious Adverse Events | General disorders | Systematic Assessment | Includes unexpected/unrelated, expected/unrelated, expected/related, and unexpected/related (all non-serious) adverse events |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Minal R. Patel, Ph.D, M.P.H | University of Michigan School of Public Health, Department of Health Behavior & Health Education | (734) 763-0087 | minalrp@umch.edu |
Not provided
| 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 | Aug 30, 2021 | Feb 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2021 | Feb 29, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Guest Assistance Program | Behavioral | The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. |
|
| Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Min value of 0, max value of 18, with higher scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Mean values were obtained, with min value of 0, max value of 1, with higher mean scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) | Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 11-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) that were measured on a 5-point scale (0: not at all - 4: very much). The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44) The change in perceived financial burden (COST measure) from baseline to 12 months is reported here as secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire. The item values are binary (yes/no). Higher number of "yes" responses indicates higher number of unmet social risk factors/higher need. (Min value of 0, max value of 20). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| Change in Unmet Social Risk Factors as Measured by Participant Questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey. The items each have three response options, in which a positive response indicates an unmet social risk factor. Higher scores indicate more unmet social risk factors (min value of 0; max value of 8). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome. | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
| BG001 | Guest Assistance Program (Control) | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Several participants refused to answer survey questions on race and ethnicity | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Income as percent of poverty level | Several participants refused to answer survey question about income | Count of Participants | Participants |
|
| Type of diabetes | Count of Participants | Participants |
|
| Number of chronic conditions | Mean | Standard Deviation | number of chronic conditions |
|
| Health Insurance Type | Count of Participants | Participants |
|
| OG001 | Guest Assistance Program (Control) | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. |
|
|
| Secondary | Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine | Systolic blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine in millimeters of mercury (e.g., 120 mm Hg). The change in systolic blood pressure from baseline to 12 months is reported here as secondary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness, unable to obtain measurement, etc. | Posted | Mean | Standard Deviation | mmHg | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| Secondary | Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Min value of 0, max value of 18, with higher scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| Secondary | Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed. The items are measured with a 4-point Likert scale. Participants answering "often" or "sometimes" to any of the items are indicated as exhibiting CRN. Mean values were obtained, with min value of 0, max value of 1, with higher mean scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome. | Change from baseline to 12-month follow-up | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| Secondary | Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) | Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 11-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) that were measured on a 5-point scale (0: not at all - 4: very much). The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44) The change in perceived financial burden (COST measure) from baseline to 12 months is reported here as secondary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness | Posted | Mean | Standard Deviation | score on a scale | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| Secondary | Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire. The item values are binary (yes/no). Higher number of "yes" responses indicates higher number of unmet social risk factors/higher need. (Min value of 0, max value of 20). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness | Posted | Mean | Standard Deviation | yes responses | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| Secondary | Change in Unmet Social Risk Factors as Measured by Participant Questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey. The items each have three response options, in which a positive response indicates an unmet social risk factor. Higher scores indicate more unmet social risk factors (min value of 0; max value of 8). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome. | Change from baseline to 12-month follow-up The overall number of participants analyzed is different from the participant flow module due to missingness | Posted | Mean | Standard Deviation | units on a scale | Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported) |
|
|
|
| 2 |
| 301 |
| 123 |
| 301 |
| 75 |
| 301 |
| EG001 | Guest Assistance Program (Control) | Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. Guest Assistance Program: The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management. | 2 | 299 | 125 | 299 | 86 | 299 |
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization | Blood and lymphatic system disorders | Systematic Assessment | Blood Pressure |
|
| Hospitalization | Metabolism and nutrition disorders | Systematic Assessment | Blood sugar |
|
| Hospitalization | General disorders | Systematic Assessment | Organ System related or Other |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | COVID |
|
| Death | General disorders | Systematic Assessment |
|
| Other Serious Event | General disorders | Systematic Assessment |
|
| Hospitalization | General disorders | Systematic Assessment | Other |
|
|
Not provided
Not provided
| Other |
|
| Hispanic |
|
| Asian |
|
| Multiple Race |
|
| Other |
|
| 201-400% |
|
| Greater than 400% |
|
| Medicare |
|
| Medicaid |
|
| Medicare + Medicaid Supplemental |
|
| Medicare + Private Supplemental |
|
| Other |
|