Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Type 2 diabetes is an illness that causes blood sugar levels to rise. Diabetes can lead to many health problems, and it can be hard to manage.

Diabetes self-management education and support, or DSMES, can help patients learn to manage type 2 diabetes. DSMES teaches self-care skills such as checking blood sugar, taking medicine, and eating healthy. DSMES also teaches people how to set self-care goals and solve problems related to diabetes. But changing behaviors to manage diabetes can be hard. Involving family members may help people with diabetes change behaviors.

In this study, the research team is comparing standard and family DSMES for improving diabetes self-care.

Who can this research help?

Results may help clinics when considering ways to help patients manage type 2 diabetes.

What is the research team doing?

The research team is enrolling 600 patient-family member pairs in which the patient has type 2 diabetes. The team is assigning each pair by chance to receive either standard DSMES or family DSMES. In the standard DSMES group, patients attend DSMES classes by themselves. In the family DSMES group, family members attend classes with the patient and learn strategies such as family goal setting and ways to support the patient.

Before DSMES classes start, after all classes end, and 6 and 12 months later, the research team is collecting data from patients and family members on

  • Diabetes-related health, such as blood glucose over time, blood pressure, and weight
  • Diabetes self-care behaviors
  • Distress related to diabetes
  • Quality of life
  • Complications from diabetes
  • Level of family support
  • Whether patients take medicine as directed
  • Patient confidence in managing diabetes
  • Family member confidence in ability to provide support

The research team is also looking in patients’ medical records to see how well they are managing their diabetes 18 months after classes end. The team is comparing outcomes between the standard and family DSMES groups.

Finally, the research team is interviewing 12 patients and 12 family members in the study to understand barriers to carrying out the family DSMES program.

Patients with type 2 diabetes, family members, and clinicians are helping with all aspects of this study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 600 patient-family member pairs where the patient has type 2 diabetes
Interventions/
Comparators
  • Family DSMES
  • Standard DSMES
Outcomes

Primary: HbA1c

Secondary: blood pressure, fasting glucose, lipids, body mass index, family support, self-efficacy, self-management behaviors, medicine adherence, diabetes-related distress, diabetes-related quality of life, diabetes-related complications, family member self-efficacy to provide support

Timeframe 3-month follow-up for primary outcome

Project Information

Pearl A. McElfish, PhD, MBA
University of Arkansas for Medical Sciences
$4,067,662
Comparative Effectiveness of Family-DSME and Standard-DSME among Diverse Populations

Key Dates

August 2019
February 2024
2019

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022