Univeristy of Alabama at Birmingham
Birmingham, Alabama, 35210, United States
NCT Number: NCT02274844
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35210, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, 6 months
Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence.
Time frame: Baseline, 6 months
Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood.
Time frame: Baseline, 6 months
2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.
Time frame: Baseline, 6 months
Finger stick, spectrophotometer to measure cholesterol level.
Time frame: Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Time frame: Baseline, 6 months
Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life.
Time frame: Baseline, 6 months
Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence.
Time frame: Baseline, 6 months
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.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: Baseline, 6 months
Change in number of diabetes medications.
Time frame: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time frame: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time frame: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Time frame: Baseline, 6 months
Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs.
Weill Medical College of Cornell University
Other
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