Results Summary and Professional Abstract

Results Summary

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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.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of a peer coaching program versus general health education in improving medication adherence and physiological risk factors for diabetes among adults living in rural Alabama.

Study Design

Design Element	Description
Design	Randomized controlled trial
Population	403 adults with diabetes who reported medication nonadherence
Interventions/ Comparators	Peer coaching program including educational DVD, workbook, and telephone-based coaching General health education DVD
Outcomes	Primary: self-reported medication adherence, hemoglobin A1c level, blood pressure, LDL cholesterol, body mass index Secondary: quality of life, medication use self-efficacy, medication beliefs
Timeframe	6-month follow-up for primary outcomes

This cluster randomized controlled trial compared the effectiveness of a peer coaching program versus general health education in improving medication adherence and physiological risk factors for diabetes among adults with diabetes living in rural Alabama. In rural Alabama, the diabetes mortality rate is 50% higher than that of the United States overall.

The research team randomly assigned patients to one of two groups. In the first group, patients received educational DVDs, which included stories about how community members accepted their health problem and overcame barriers to medication adherence, and an activity book. During 11 phone sessions over six months, peer coaches worked through the activity book with patients, discussed health goals, and helped patients figure out how to overcome barriers to meeting their goals. The peer coaches were African-American women who had diabetes or took care of someone who did. In the second group, patients received a general health education DVD that covered topics such as cancer screening, eye health, and oral health.

The study included 403 adults with diabetes living in rural Alabama who reported nonadherence with their diabetes medication. Of these, 91% were African American, and 9% were other races. The average age was 57, 78% were female, and 69% had annual incomes below $20,000.

At baseline and six months later, the research team collected patient surveys and physiological measures.

Rural community members provided input throughout the study.

Results

After six months, patients who were in the peer coaching program reported more improvement in medication adherence than patients who were not (p<0.01). The two groups did not differ significantly in hemoglobin A1c, blood pressure, LDL cholesterol, or body mass index.

Compared with patients who were not in the program, patients who were reported more improvement in medication use self-efficacy and belief in the need for medications (p<0.05). The two groups did not differ significantly in quality of life.

Limitations

Patients reported lack of access to fresh fruits and vegetables, which limited the practicality of the program’s dietary lessons. The study took place in rural Alabama. Results may differ in other locations. The study’s six-month follow-up period may not have been long enough to demonstrate changes in the physiological outcomes.

Conclusions and Relevance

The peer coaching program improved self-reported medication adherence and medication use self-efficacy among adults with diabetes living in rural Alabama. The program did not significantly improve physiological risk factors for diabetes or quality of life.

Future Research Needs

Future research could test the program in other rural areas and track patients for longer than six months.

More on this Project  

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

View the COI disclosure form.

Project Details

Principal Investigator

Monika M. Safford, MD

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

Improving Medication Adherence in the Alabama Black Belt

Board Approval Date

December 2013

Project End Date

September 2020

Organization

Joan & Sanford I. Weill Medical College of Cornell University^

Year Awarded

2013

State

New York

Year Completed

2020

Project Type

Research Project

Health Conditions  

Nutritional and Metabolic Disorders

Diabetes

Intervention Strategies

Behavioral Interventions
Other Clinical Interventions
Other Health Services Interventions
Technology Interventions
Training and Education Interventions

Populations

Low Health Literacy/Numeracy
Low Income
Racial/Ethnic Minorities
Rural
Women

Funding Announcement

Addressing Disparities

Project Budget

$2,126,514

DOI - Digital Object Identifier

10.25302/11.2020.AD.130603565IC

Study Registration Information

HSRP20143401

NCT02274844