NCT03092063

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

Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Tomando Control-Nurse	Tomando Control de su Diabetes-Nurse is a community-based intervention given in six 2.5 hour sessions. The Spanish-language sessions are led by two trained Registered Nurses. Subjects covered in these sessions include: 1) techniques to deal with the symptoms of diabetes and associated conditions; 2) appropriate exercise; 3) healthy eating; 4) correct use of diabetes medications; and 5) working more effectively with health care providers in a collaborative partnership. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management strategies.
BEHAVIORAL	Tomando Control-Promotora	Tomando Control de su Diabetes-Promotora is a community-based intervention given in six 2.5 hour sessions. The Spanish-language sessions are led by two trained promotoras. Subjects covered in these sessions include: 1) techniques to deal with the symptoms of diabetes and associated conditions; 2) appropriate exercise; 3) healthy eating; 4) correct use of diabetes medications; and 5) working more effectively with health care providers in a collaborative partnership. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management strategies.
BEHAVIORAL	Enhanced engagement	The Tomando Control clinician (either a promotora or a Registered Nurse, depending on the original group assignment), will conduct up to three home visits that are designed to explain the purpose of the TC intervention to a key relative so as to re-engage the family member in the group process
BEHAVIORAL	Multifamily Group	The multifamily group consists of three components: three initial "joining" sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions.

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-12-31
• Completion: 2021-07-31
• First posted: 2017-03-27
• Last updated: 2021-09-29

Locations

1 site across 1 country: United States