Clinical trial NCT03092063: Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes
Official title: Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Diabetes Self-Management Education
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.

Detailed description: The project evaluates four culturally adapted, family-based treatments designed to improve health status, self-management behaviors and self-efficacy among Mexican-Americans with Type 2 diabetes using a Sequential, Multiple Assignment Randomized Trial in a public health setting. In the first phase of the study, subjects will be randomly assigned to six 2.5 hour sessions (three months) of either: 1) Tomando Control de su Diabetes (TC), a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by community health workers (promotoras) working with individual patients and families; or 2) TC delivered by health professionals (licensed nurses). Evaluations will be made at baseline, three months, six months and 12 months. After six weeks of treatment (at the midway point of the intervention), subjects will be assessed for improvement in diabetes self-management behaviors (the primary outcome). In the second phase of the study, those subjects who have improved their diabetes self-management behaviors by 50% over baseline will be continued in their assigned treatment for the duration of three months. Those subjects who do not meet this target will be re-randomized to receive either: 1) an augmented version of TC that has a specific focus on engaging family members; or 2) a multifamily group treatment led by nurses specially trained in teaching diabetes self-management skills for an additional three months.

Eligibility criteria: Inclusion Criteria:

1. Mexican origin and speaks Spanish fluently
2. age 18 years or older
3. medical chart diagnosis of Type 2 diabetes
4. living with at least one adult family member who is willing to participate.

Exclusion Criteria:

1. diagnosis of Type 1 diabetes
2. participation in another Diabetes Self-management education program within the past 12 months
3. pregnancy
4. significant cognitive impairment.

Primary outcomes:
measure: Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities)
timeFrame: This outcome measure will be assessed at baseline, six weeks, three months, six months and 12 months. The primary outcome is change from baseline as compared to the subsequent assessment points.
Secondary outcomes:
measure: Diabetes Self-Efficacy (Stanford Self-Efficacy Scale)
timeFrame: This outcome measure will be assessed at baseline, three months, six months and 12 months.
measure: Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale)
timeFrame: This outcome measure will be assessed at baseline, three months, six months and 12 months.
measure: Family Support (Diabetes Family Support Behavior Checklist)
timeFrame: This outcome measure will be assessed at baseline, three months, six months and 12 months.
measure: Collaborative goal setting (Patient Assessment of Chronic Illness Care)
timeFrame: This outcome measure will be assessed at baseline, three months, six months and 12 months.
measure: Glycemic control
timeFrame: This outcome measure will be assessed at baseline, three months, six months and 12 months.
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
affiliation: Olive View-UCLA Education & Research Institute
name: alex kopelowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: