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Improving Medication Adherence in the Alabama Black Belt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274844
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Medication Adherence Behavioral: Living Well with Diabetes Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Medication Adherence in the Alabama Black Belt
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: 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.
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

No Intervention: 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 Outcome Measures :
  1. Self Reported Medication Adherence [ Time Frame: change in medication adherence at 6 months ]
    patient-reported adherence to medications

  2. hemoglobin test (hba1c), percentage [ Time Frame: change in hba1c percentage at 6 months ]
    finger stick, point-of-care a1c testing

  3. low-density lipoprotein (LDL) cholesterol, mg/dL [ Time Frame: change in LDL-cholesterol at 6 months ]
    finger stick, spectrophotometer to measure cholesterol level

  4. Blood pressure, mmhg [ Time Frame: change in blood pressure at 6 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274844


Locations
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United States, Alabama
Univeristy of Alabama at Birmingham
Birmingham, Alabama, United States, 35210
Sponsors and Collaborators
Weill Medical College of Cornell University
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Investigators
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Principal Investigator: Monika M Safford, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02274844    
Other Study ID Numbers: PCORI-R-AD-1306-03565
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will stay at UAB