Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 10, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedSeptember 29, 2021
September 1, 2021
3.8 years
March 10, 2017
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities)
This 11-item scale assesses ADA-recommended health activities in diet, exercise, glucose self-monitoring, medication adherence and foot care. The mean number of days in the past week that activities are performed is calculated on a scale of 0-7; a high mean score indicates better diabetes self-management.
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 (5)
Diabetes Self-Efficacy (Stanford Self-Efficacy Scale)
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale)
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Family Support (Diabetes Family Support Behavior Checklist)
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Collaborative goal setting (Patient Assessment of Chronic Illness Care)
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Glycemic control
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Study Arms (6)
Tomando Control-Nurse
EXPERIMENTALTomando 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.
Tomando Control-Promotora
EXPERIMENTALTomando 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.
Enhanced Engagement-Nurse
EXPERIMENTALTomando 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.
Enhanced Engagement-Promotora
EXPERIMENTALTomando 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.
Multifamily Group-Promotora
EXPERIMENTALIf 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.
Multifamily Group-Nurses
EXPERIMENTALIf 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.
Interventions
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.
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.
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
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.
Eligibility Criteria
You may qualify if:
- Mexican origin and speaks Spanish fluently
- age 18 years or older
- medical chart diagnosis of Type 2 diabetes
- living with at least one adult family member who is willing to participate.
You may not qualify if:
- diagnosis of Type 1 diabetes
- participation in another Diabetes Self-management education program within the past 12 months
- pregnancy
- significant cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
Related Publications (2)
Kopelowicz A, Wali S, Polzin R, Ruiz ME, Nandy K. Promotore-Led Versus Registered Nurse-Led Diabetes Self-Management Education in Mexican Americans: A Randomized Clinical Trial. Sci Diabetes Self Manag Care. 2023 Oct;49(5):374-383. doi: 10.1177/26350106231192353. Epub 2023 Aug 18.
PMID: 37593833DERIVEDKopelowicz A, Nandy K, Ruiz ME, Polzin R, Kurator K, Wali S. Improving Self-management of Type 2 Diabetes in Latinx Patients: Protocol for a Sequential Multiple Assignment Randomized Trial Involving Community Health Workers, Registered Nurses, and Family Members. JMIR Res Protoc. 2023 Jan 16;12:e44793. doi: 10.2196/44793.
PMID: 36645708DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
alex kopelowicz, MD
Olive View-UCLA Education & Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Raters are blind to treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
March 10, 2017
First Posted
March 27, 2017
Study Start
March 1, 2017
Primary Completion
December 31, 2020
Study Completion
July 31, 2021
Last Updated
September 29, 2021
Record last verified: 2021-09