Family-Focused Diabetes Management for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Disqualifiers: Pregnancy, Terminal condition, Cognitive impairment
No Placebo Group
Trial Summary
What is the purpose of this trial?
A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Family dyad diabetes intervention for Type 2 Diabetes?
Is the Family-Focused Diabetes Management for Type 2 Diabetes treatment safe for humans?
How is the Family Dyad Diabetes Self-Management Intervention treatment different from other treatments for type 2 diabetes?
Research Team
Eligibility Criteria
African American adults over 40 with type 2 diabetes and a family member (spouse, adult child, or sibling) who live together can join. Both must speak English and be able to walk. The patient needs an A1c > 7.5% and diagnosed for at least six months. Those with cognitive impairments, advanced conditions, or unclear diabetes diagnosis are excluded.Inclusion Criteria
You are African American and have type 2 diabetes.
Family members being a spouse, adult child, or sibling
I have type 2 diabetes and can walk.
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Exclusion Criteria
I have type 2 diabetes but no definitive proof of it.
You have type 2 diabetes and your family members cannot make decisions for you.
You have type 2 diabetes and a family member who is pregnant or has a serious illness.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 10 virtual group sessions on diabetes self-management and family support over 12 weeks
12 weeks
10 virtual sessions
Post-intervention Assessment
Participants are assessed immediately after the intervention for changes in health-related quality of life and diabetes control
1 week
Follow-up
Participants are monitored for changes in diabetes control and blood pressure six months after the intervention
6 months
Treatment Details
Interventions
- Family dyad diabetes intervention (Behavioral Intervention)
Trial OverviewThe trial is testing how well a program designed for African American adults with type 2 diabetes and their family members works in improving blood sugar control and quality of life. It's a randomized controlled study comparing the new intervention against usual care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.
Group II: ControlActive Control1 Intervention
All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State University College of NursingColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Trials
891
Patients Recruited
2,659,000+
References
Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. [2023]Diabetes self-management education and support (DSMES) is an effective approach for improving diabetes self-care behaviors to achieve improved glycemic management and other health outcomes. Engaging family members may improve outcomes, both for the person with diabetes (PWD) and for the family members. However, family models of DSMES have been inconsistently defined and delivered. We operationalize Family-DSMES to be generalizable and replicable, detail our protocol for a comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods implementation evaluation plan.
Effects of a family diabetes self-management education intervention on the patients' supporters. [2023]Diabetes self-management education (DSME) programs that engage the families of patients with diabetes have shown to be effective in improving diabetes-related outcomes of the patients. The health effects of these "family models" of DSME on participating family members are rarely studied. Opportunity exists for the participating family members to benefit from the healthy lifestyle recommendations offered through such programs.
The Effect of Family Diabetes Self-management Education on Self-care Behaviors of Marshallese Adults with Type 2 Diabetes. [2020]Objectives: In this study, we assessed the effect of Family Diabetes Self-Management Educa- tion (DSME) intervention on changes in self-care behaviors among Marshallese adults with type 2 diabetes. Methods: Marshallese adults (N = 211) with type 2 diabetes were randomized to a Family DSME intervention or a Standard DSME intervention. We assessed changes in diabetes- related self-care behaviors from baseline to 12 months within and between study arms using descriptive statistics and mixed effects logistic regression models adjusted for demographic characteristics and use of diabetes medication. Results: Family DSME participants had increased engagement in glucose monitoring and doctor visits, whereas Standard DSME participants had increased engagement in glucose monitoring. Family DSME participants increased engagement in glucose monitoring more than Standard DSME participants. Conclusions: DSME can improve some diabetes related self-care behaviors. Future studies on diabetes management should consider developing and testing interventions that seek to improve long-term rates of engagement in self-care behaviors.
Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. [2022]Diabetes self-management education (DSME) can be delivered in many forms. Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other. assess effects of group-based DSME compared to routine treatment on clinical, lifestyle and psychosocial outcomes in type-2 diabetes patients.
Effectiveness of Diabetes Self-Management Education in Community Health. [2020]Diabetes self-management education (DSME) programs utilize a multidisciplinary, skills-based approach allowing participants to make self-management choices and follow a comprehensive plan of care, improving their glycemic control.
Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. [2022]Diabetes self-management educational (DSME) interventions can vary considerably, and it is unclear what is the operational conceptualization of the ideal delivery to individuals with type 2 diabetes (T2D).