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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Alabama at Birmingham | OTHER |
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Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care.
Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal.
Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are:
Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing.
Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes).
This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Coaching | Experimental | The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. |
|
| Usual Care | No Intervention | At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Living Well with Diabetes Program | Behavioral | The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self Reported Medication Adherence | Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence. | Baseline, 6 months |
| Change in Percentage of HbA1c | Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood. | Baseline, 6 months |
| Change in Blood Pressure | 2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor. | Baseline, 6 months |
| Change in Low-Density Lipoprotein (LDL) Cholesterol | Finger stick, spectrophotometer to measure cholesterol level. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life as Assessed With the Short Form 12- Mental Component | Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. | Baseline, 6 months |
| Change in Quality of Life as Assessed With the Short Form-12- Physical Component |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | Baseline, 6 months |
| Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika M Safford, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Alabama at Birmingham | Birmingham | Alabama | 35210 | United States |
Data will stay at UAB
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Recruitment efforts in this area focused on attending health fairs, posting flyers at community locations such as libraries and churches. The main focus of recruitment was in the county's safety net clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Coaching | The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching |
| FG001 | Usual Care | At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Coaching | The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching |
| 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 Self Reported Medication Adherence | Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
6 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 | Peer Coaching | The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Living Well with Diabetes Program: The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching |
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Delays in follow-up data collection for some participants could impact the A1c findings, medication adherence was not measured using objective means, and participants in this sample were mostly women, possibly limiting generalizability to men.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Andreae | University of Wisconsin-Madison | 608-265-8195 | sandreae@wisc.edu |
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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 | Aug 16, 2016 | Jul 9, 2020 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. |
| Baseline, 6 months |
| Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c | Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence. | Baseline, 6 months |
| Change in Diabetes-Specific Quality of Life | Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress. | Baseline, 6 months |
| Number of Physician Office Visits 6 Months | 6 months |
| Number of Hospital Stays at 6 Months | 6 months |
| Number of Emergency Visits at 6 Months | 6 months |
| Change in Diabetes Medication Counts | Change in number of diabetes medications. | Baseline, 6 months |
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. |
| Baseline, 6 months |
| Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | Baseline, 6 months |
| Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | Baseline, 6 months |
| BG001 | Usual Care | At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | 1 subject in the usual care arm declined to provide this information. | Count of Participants | Participants |
|
| Annual Income | 10 subjects in the peer coaching arm and 11 subjects in the usual care arm declined to provide this information. | Count of Participants | Participants |
|
| Education | 1 subject in the peer coaching arm declined to provide this information. | Count of Participants | Participants |
|
| Employment | 1 subject in the peer coaching arm and 2 subjects in the usual care arm declined to provide this information. | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Hba1c | Count of Participants | Participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Medication Adherence Score as measured by the Morisky Medication Adherence Scale | 4-item Morisky Medication Adherence Scale-a validated assessment tool used to measure non-adherence. If subjects answered yes to 0 questions, this would indicate high adherence and if subjects answered yes to 4 questions, this would indicate low adherence. | Count of Participants | Participants |
|
| Number of Subjects Taking Insulin | Count of Participants | Participants |
|
| OG001 | Usual Care | At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs. |
|
|
|
| Primary | Change in Percentage of HbA1c | Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline, 6 months |
|
|
|
| Primary | Change in Blood Pressure | 2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | mmHg | Baseline, 6 months |
|
|
|
| Primary | Change in Low-Density Lipoprotein (LDL) Cholesterol | Finger stick, spectrophotometer to measure cholesterol level. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 months |
|
|
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| Secondary | Change in Quality of Life as Assessed With the Short Form 12- Mental Component | Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
|
| Secondary | Change in Quality of Life as Assessed With the Short Form-12- Physical Component | Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
|
| Secondary | Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c | Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
|
| Secondary | Change in Diabetes-Specific Quality of Life | Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress. | 39 participants in the peer coaching arm and 34 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
|
| Secondary | Number of Physician Office Visits 6 Months | This data was not collected. | Posted | 6 months |
|
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| Secondary | Number of Hospital Stays at 6 Months | This data was not collected. | Posted | 6 months |
|
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| Secondary | Number of Emergency Visits at 6 Months | This data was not collected. | Posted | 6 months |
|
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| Secondary | Change in Diabetes Medication Counts | Change in number of diabetes medications. | 44 participants in the peer coaching arm and 38 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Medications | Baseline, 6 months |
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| Other Pre-specified | Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
|
| Other Pre-specified | Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
|
|
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| Other Pre-specified | Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
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| Other Pre-specified | Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications) | Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. | 39 participants in the peer coaching arm and 31 participants in the usual care arm were not analyzed because the participants were unable to be contacted, had health reasons, or did not have time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 6 months |
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|
| 0 |
| 203 |
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | Usual Care | At enrollment, the investigators will provide an educational DVD on general health and wellness topics including vaccination, cancer screening, osteoporosis and other topics not related to diabetes care. There will be no peer storytelling on these DVDs. | 0 | 270 | 0 | 270 | 0 | 270 |
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| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| >High School |
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| Yes to 2 questions |
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| Yes to 3 questions |
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| Yes to 4 questions |
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| Missing |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change at 6 months |
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| Change |
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| Change |
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| Change |
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| Change |
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