Improving Medication Adherence in the Alabama Black Belt

Diabetes Mellitus Clinical Trial

Official title:

Improving Medication Adherence in the Alabama Black Belt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274844
• Other study ID #: PCORI-R-AD-1306-03565
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Medication Adherence

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Univeristy of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	Baseline, 6 months
Other	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
Other	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
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.	Baseline, 6 months
Primary	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
Primary	Change in Blood Pressure	2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor.	Baseline, 6 months
Primary	Change in Low-Density Lipoprotein (LDL) Cholesterol	Finger stick, spectrophotometer to measure cholesterol level.	Baseline, 6 months
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.	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.	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.	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.	Baseline, 6 months
Secondary	Number of Physician Office Visits 6 Months		6 months
Secondary	Number of Hospital Stays at 6 Months		6 months
Secondary	Number of Emergency Visits at 6 Months		6 months
Secondary	Change in Diabetes Medication Counts	Change in number of diabetes medications.	Baseline, 6 months