Clinical trial NCT02274844: Improving Medication Adherence in the Alabama Black Belt
Official title: Improving Medication Adherence in the Alabama Black Belt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Medication Adherence
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Alabama at Birmingham
First posted: 2014-10-24
Enrollment: 473
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adults
* type 2 diabetes
* taking medications for diabetes
* medication non adherent

Exclusion Criteria:

* nursing home residence
* plans to move away in the next year
* advanced illnesses such as hemodialysis, cancer or dementia

Primary outcomes:
measure: Change in Self Reported Medication Adherence
timeFrame: Baseline, 6 months
measure: Change in Percentage of HbA1c
timeFrame: Baseline, 6 months
measure: Change in Blood Pressure
timeFrame: Baseline, 6 months
measure: Change in Low-Density Lipoprotein (LDL) Cholesterol
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Quality of Life as Assessed With the Short Form 12- Mental Component
timeFrame: Baseline, 6 months
measure: Change in Quality of Life as Assessed With the Short Form-12- Physical Component
timeFrame: Baseline, 6 months
measure: Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c
timeFrame: Baseline, 6 months
measure: Change in Diabetes-Specific Quality of Life
timeFrame: Baseline, 6 months
measure: Number of Physician Office Visits 6 Months
timeFrame: 6 months
measure: Number of Hospital Stays at 6 Months
timeFrame: 6 months
measure: Number of Emergency Visits at 6 Months
timeFrame: 6 months
measure: Change in Diabetes Medication Counts
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)
timeFrame: Baseline, 6 months
measure: Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)
timeFrame: Baseline, 6 months
measure: Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)
timeFrame: Baseline, 6 months
measure: Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications)
timeFrame: Baseline, 6 months
Locations:
city: Birmingham
country: United States
facility: Univeristy of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Weill Medical College of Cornell University
name: Monika M Safford, MD
role: PRINCIPAL_INVESTIGATOR
References: