Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes

Clinical Trial ID: NCT03092063

Description

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.

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.


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.

  • Start Date

    2017-03-01

  • Last Updated

    2019-10-18

  • Sponsor

    University of California, Los Angeles

  • Condition Name

    Type2 Diabetes

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