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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK107572-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| Louisiana State University Health Sciences Center Shreveport | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.
The secondary aims are to:
investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
assess the costs associated with implementing the intervention from a health system perspective.
The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes:
While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.
The primary aims are to:
test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.
The secondary aims are to:
investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and
assess the costs associated with implementing the intervention from a health system perspective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | Other | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months |
|
| Intervention | Other | ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP Living with Diabetes Guide | Other | American Colleges of Physicians (ACP) Living Well with Diabetes Guide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | Six months |
| Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Knowledge | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. | Three months |
| Diabetes Knowledge (0-13) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristie Hadden, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Family Medical Center Northwest | Fayetteville | Arkansas | 72703 | United States | ||
| UAMS Family Medical Center Fort Smith |
The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon request. Consulting with program officer to ensure data sharing compliance.
This will be available 6 months after publication of main study results.
Require an NIH investigator with an IRB approved protocol, to conduct secondary data analysis of the available dataset.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook |
| FG001 | Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
|
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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 | Feb 4, 2019 |
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| ADA Living Well with Diabetes Workbook | Other | American Diabetes Association (ADA) Living Well with Diabetes Workbook |
|
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
| Six months |
| Fort Smith |
| Arkansas |
| 72901 |
| United States |
| UAMS Family Medical Center Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| UAMS Family Medical Center Magnolia | Magnolia | Arkansas | 71753 | United States |
| UAMS Family Medical Center Pine Bluff | Pine Bluff | Arkansas | 71603 | United States |
| UAMS Family Medical Center Texarkana | Texarkana | Arkansas | 71854 | United States |
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide |
| COMPLETED |
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| NOT COMPLETED |
|
|
| 3 Months |
|
|
| 6 Month |
|
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| 6 Month HbA1c |
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| 12 Month HbA1c |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook |
| BG001 | Intervention | ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||
| Health Literacy (NVS) | Health Literacy (NVS) Newest Vital Sign | Count of Participants | Participants |
|
| 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 | Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | 119 individuals were excluded from analysis, because they did not have a 6 month HbA1c value within the designated window. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of glycated hemoglobin | Six months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | 240 individuals were excluded from analysis, because they did not have a 12 month HbA1c value within the designated window. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of glycated hemoglobin | Twelve months |
|
| |||||||||||||||||||||||||||||
| Secondary | Diabetes Knowledge | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. | 116 participants were excluded, missed 3 month visit. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Three months |
|
| |||||||||||||||||||||||||||||
| Secondary | Diabetes Knowledge (0-13) | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. | 142 participants were excluded, missed 6 month visit. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Six months |
|
|
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 | Enhanced Usual Care | ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook | 6 | 394 | 0 | 394 | 0 | 394 |
| EG001 | Intervention | ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide | 3 | 362 | 0 | 362 | 0 | 362 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristie Hadden, PhD/Associate Professor | University of Arkansas for Medical Sciences | 501-993-3178 | KBHADDEN@uams.edu |
| Sep 2, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2018 | Sep 2, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| High School Graduate |
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| Some College |
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| College Graduate |
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| Refused to answer question |
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| Adequate |
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