Improving Medication Adherence in the Alabama Black Belt

NCT02274844 | Completed Results

• 1 other identifier: PCORI-R-AD-1306-03565
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Medication Adherence

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Change in Quality of Life as Assessed With the Short Form 12- Mental Component

  Baseline, 6 months

• Change in Quality of Life as Assessed With the Short Form-12- Physical Component

  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

  Baseline, 6 months

• Change in Diabetes-Specific Quality of Life

  Baseline, 6 months

• Number of Physician Office Visits 6 Months

  6 months

Other Outcomes (4)

• Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful)

  Baseline, 6 months

• Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications)

  Baseline, 6 months

• Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications)

  Baseline, 6 months

Study Arms (2)

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.

Behavioral: Living Well with Diabetes Program

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.

Interventions

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

Peer Coaching

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Univeristy of Alabama at Birmingham

Birmingham, Alabama, 35210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Susan Andreae
• Organization: University of Wisconsin-Madison

sandreae@wisc.edu

608-265-8195

Study Officials

• Monika M Safford, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 24, 2014
• Study Start: April 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: October 29, 2020
• Results First Posted: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)