Family-Focused Diabetes Management for Type 2 Diabetes
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Ohio State University
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).
Is the Family Dyad Diabetes Self-Management Intervention a promising treatment for Type 2 Diabetes?Yes, the Family Dyad Diabetes Self-Management Intervention is promising because it helps people with diabetes and their families improve their health by encouraging better self-care behaviors, like monitoring blood sugar and visiting the doctor more often.23456
What safety data exists for Family-Focused Diabetes Management for Type 2 Diabetes?The provided research does not specifically address safety data for Family-Focused Diabetes Management or its variants. However, it highlights the effectiveness of family-involved diabetes self-management education (DSME) in improving diabetes-related outcomes and self-care behaviors. The studies suggest that engaging family members in DSME can be beneficial, but they do not provide specific safety data or report adverse effects related to these interventions.12345
What data supports the idea that Family-Focused Diabetes Management for Type 2 Diabetes is an effective treatment?The available research shows that Family-Focused Diabetes Management, which involves family members in the diabetes care process, can lead to better outcomes for people with type 2 diabetes. For example, one study found that participants in a Family Diabetes Self-Management Education program were more engaged in important self-care activities like monitoring their blood sugar and visiting the doctor compared to those in a standard program. This suggests that involving family members can enhance the effectiveness of diabetes management. Another study highlights that these family-focused programs can improve diabetes-related outcomes for patients, indicating that this approach can be more beneficial than standard treatments.12346
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
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
I am 40 or older with type 2 diabetes.
My A1c level is above 7.5% and I have type 2 diabetes.
Treatment Details
The 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.
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 UniversityLead Sponsor
References
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.
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.
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.
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).
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.