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 |
|
| 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 |
| 3-month follow-up for primary outcome |