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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Type2 Diabetes

Treatments: Behavioral: Multifamily Group; Behavioral: Tomando Control-Promotora; Behavioral: Enhanced engagement; Behavioral: Tomando Control-Nurse

Study type: Interventional

Funder types: Other

Identifiers

NCT03092063

5R01NR015809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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330 participants in 6 patient groups

Tomando Control-Nurse

Experimental group

Description:

Tomando Control de su Diabetes-Nurse is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families.

Treatment:

Behavioral: Tomando Control-Nurse

Tomando Control-Promotora

Experimental group

Description:

Tomando Control de su Diabetes-Promotora is 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.

Treatment:

Behavioral: Tomando Control-Promotora

Enhanced Engagement-Nurse

Experimental group

Description:

Tomando Control de su Diabetes-Nurse is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.

Treatment:

Behavioral: Tomando Control-Nurse

Behavioral: Enhanced engagement

Enhanced Engagement-Promotora

Experimental group

Description:

Tomando Control de su Diabetes-Promotora is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.

Treatment:

Behavioral: Tomando Control-Promotora

Behavioral: Enhanced engagement

Multifamily Group-Promotora

Experimental group

Description:

If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the promotoras, they may be randomized to receive a multifamily group intervention consisting 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.

Treatment:

Behavioral: Tomando Control-Promotora

Behavioral: Multifamily Group

Multifamily Group-Nurses

Experimental group

Description:

If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the nurses, they may be randomized to receive a multifamily group intervention consisting 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.

Treatment:

Behavioral: Tomando Control-Nurse

Behavioral: Multifamily Group