CompletedNot Applicable

Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

United States1,100 participantsStarted 2021-01-04

Plain-language summary

The investigators conducted a comparative effectiveness randomized controlled trial comparing a family model diabetes self-management education and support intervention (Family-DSMES) and a standard model DSMES intervention (Standard-DSMES). The trial included 550 persons with type 2 diabetes mellitus (PWD) and 550 of their family members/support persons. PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. In the Family-DSMES arm, the family members/support persons of the PWD took part in the educational sessions. In the Standard-DSMES arm, the family members/support persons did not participate in educational sessions or goal setting. Both interventions were delivered in a group setting via telehealth. Baseline, immediate post-intervention (12 weeks) and 6 months post-intervention data were collected from PWD and family members/support persons in both study arms. In both study arms, we obtained a medical records release to abstract the primary outcome at 12 months post-intervention and 18 months post-intervention for PWD. The primary outcome was change in Hemoglobin A1c between baseline and immediate post-intervention among PWD.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adults ≥18 years of age * have HbA1c ≥ 7.0% * speak English * have a family member/support person willing to take part in the study Exclusion Criteria: * have received formal DSMES in the past three years * have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness * have plans to move out of the area within 18 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemoglobin A1c (HbA1c)

Timeframe: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention

Trial details

NCT IDNCT04334109

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-17

Results submitted2026-03-27

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials