Family Model DSME in FBOs in the RMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family Model Diabetes Self-Management Education and Support, Family Model Diabetes Self-Management Education and Support (Wait-list).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Overview
Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.
Interventions
- Behavioral Family Model Diabetes Self-Management Education and Support
Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting. - Behavioral Family Model Diabetes Self-Management Education and Support (Wait-list)
Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.
Primary outcome measures
- Glycemic control, measured by change in mean HbA1c (%) from baseline [Time frame: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention]
Eligibility criteria
Inclusion criteria
- self-reported Marshallese
- 18 years of age or older
- have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
- have at least one family member willing to take part in the study
Exclusion criteria
- has received diabetes self-management education in the past five years
- has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
- plans to move out of the geographic region
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UAMS Institute for Community Health Innovation — Springdale
Identifiers
NCT: NCT05502016 · 263202 · 1R01DK128145-01A1