Results Summary

What was the research about?

Diabetes is a long-term health problem that causes high blood sugar levels. Medicine can help people manage diabetes and prevent other health problems. But up to half of patients with diabetes don’t take medicines as directed.

In rural Alabama, many more people die as a result of diabetes than in the United States as a whole. In this study, the research team wanted to learn if a peer coaching program helped adults with diabetes living in rural Alabama take medicine as directed and improve their health. The peer coaches were African-American women who had diabetes or took care of someone who did. The coaches supported patients in managing their diabetes. The team compared adults in the program with those who weren’t in it.

What were the results?

After six months, compared with patients who weren’t in the program, patients who were reported more improvement in

  • How often they took their medicine as directed
  • How confident they were in their ability to keep up with their medicine
  • How strongly they believed it was important to take their medicine

Patients who were and weren’t in the program didn’t differ in blood sugar, blood pressure, cholesterol levels, or body mass index. They also didn’t differ in quality of life.

Who was in the study?

The study included 403 adults with diabetes living in rural Alabama. Of these patients, 91 percent were African American, and 9 percent were other races. The average age was 57, and 78 percent were women. Also, 69 percent earned less than $20,000 per year. All patients reported problems taking medicine as directed before the study.

What did the research team do?

The research team assigned patients by chance to one of two groups. In the first group, patients received educational DVDs and an activity book for the peer coaching sessions. The DVDs told stories about how people accepted their diabetes and overcame barriers to taking medicine. During 11 phone sessions over six months, peer coaches helped patients

  • Work through the activity book
  • Set health goals
  • Figure out how to overcome barriers to meeting goals

In the second group, patients received a general health education DVD. The DVD covered topics such as cancer screening, eye health, and oral health.

At the start of the study and six months later, the research team collected patient surveys and measured patients’ blood sugar, blood pressure, cholesterol, and body mass index.

People living in rural Alabama provided input throughout the study.

What were the limits of the study?

Some patients in the study said they didn’t have access to the fresh fruits and vegetables the program suggested, making it hard to follow the diet suggestions. The study took place in rural Alabama. Results may differ in other locations. The study may not have followed patients long enough to see changes in health.

Future research could test the program in other rural areas.

How can people use the results?

People who provide health services in rural areas could use the results when considering ways to help people with diabetes take medicines as directed.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers had questions about how the researchers measured adherence to the intervention and about the clinical meaning of the changes observed. The researchers agreed that using self-reported adherence was a limitation of this study. They added more information about baseline medication adherence levels for the intervention and control groups. The researchers noted that since this was a randomized trial, any bias in self-reported adherence should be similar between groups and therefore not account for any differences seen.
  • The reviewers noted that change in medication adherence did not appear to lead to change in health outcomes. Given the existing literature on the adherence scale used in this study, the reviewers asked the researchers to report how much medication adherence change would be needed to change blood pressure outcomes. The researchers noted that past work has shown that self-reported adherence does correlate with disease control but said there is less information on whether self-reported measures effectively detect changes over time. The researchers said they had no data to assess how much self-reported change in medication adherence would be enough to affect a physiologic measure like blood pressure control.
  • The reviewers suggested addressing whether such an intensive intervention, which required 11 phone calls per patient, was worth the effort in order to improve medication adherence when clinical outcomes did not improve. The researchers responded that even though the intervention did not improve clinical outcomes, it showed that lay members of the community could be trained as peer coaches to change patients’ beliefs about taking medication, which is a critical first step in improving medication adherence.
  • The reviewers asked what the contribution was of the work in aim 1 of the project, since much that the researchers reported was already known in the literature. The researchers explained that the goal of the aim 1 qualitative work was to engage patient stakeholders in the development of the intervention using the recommended framework.
  • The reviewers asked whether the intervention improved participants’ knowledge and health behaviors. The researchers replied that they saw a nonsignificant increase in knowledge. Diet also did not change significantly. The researchers said the intervention group did show a significant increase in the number of days walked for exercise.
  • The reviewers suggested that the program might have led to greater changes in outcomes if the study had selected participants who were at greater risk of poor diabetes outcomes. The researchers agreed and said that they did focus on high-need communities for the intervention. However, in their discussions with community stakeholders, the stakeholders strongly advised against restrictive inclusion criteria, which could be seen negatively in a community with high levels of distrust for medical research.

Conflict of Interest Disclosures

Project Information

Monika M. Safford, MD
Joan & Sanford I. Weill Medical College of Cornell University^
$2,126,514
10.25302/11.2020.AD.130603565IC
Improving Medication Adherence in the Alabama Black Belt

Key Dates

December 2013
September 2020
2013
2020

Study Registration Information

^Monika M. Safford, MD was affiliated with University of Alabama at Birmingham when this project was funded.

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Last updated: March 4, 2022