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

• ClinicalTrials.gov Identifier: NCT03092063
• Recruitment Status: Recruiting
• First Posted: March 27, 2017
• Last Update Posted: October 22, 2019
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Alex Kopelowicz, M.D., University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type2 Diabetes	Behavioral: Tomando Control-Nurse; Behavioral: Tomando Control-Promotora; Behavioral: Enhanced engagement; Behavioral: Multifamily Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Diabetes Self-Management Education
• Masking: Single (Outcomes Assessor)
• Masking Description: Raters are blind to treatment condition.
• Primary Purpose: Treatment
• Official Title: Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: July 1, 2020
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tomando Control-Nurse; 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.	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.
Experimental: Tomando Control-Promotora; 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.	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.
Experimental: Enhanced Engagement-Nurse; 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.	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: 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
Experimental: Enhanced Engagement-Promotora; 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.	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
Experimental: Multifamily Group-Promotora; 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.	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: 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.
Experimental: Multifamily Group-Nurses; 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.	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: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities) [ Time Frame: 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. ]
   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.

Secondary Outcome Measures :

1. Diabetes Self-Efficacy (Stanford Self-Efficacy Scale) [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
   An 8-item measure that assesses the confidence of a person with diabetes to manage diet, exercise, knowledge of blood glucose and the illness, and control over diabetes. Scores range from 1-10, from no confidence to totally confident; higher scores indicate greater confidence.
2. Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale) [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
   This 10-item scale assesses knowledge of glucose management, lifestyle modifications, recognition and treatment of hyper- and hypoglycemia, and activities to prevent long-term consequences of the disease. Correct answers receive a score of 1. Each item score is summed ranging from 0-10, with a high score indicating better knowledge about diabetes.
3. Family Support (Diabetes Family Support Behavior Checklist) [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
   This 17-item scale uses a 5-point Likert range to assess perceptions of family member support of the person with T2DM in medication taking, glucose self-monitoring, exercise and diet. Positive and negative items are summed separately and higher scores indicate stronger perception of family support.
4. Collaborative goal setting (Patient Assessment of Chronic Illness Care) [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
   A 20-item patient survey that evaluates the quality and patient centeredness of chronic illness care received according to the Chronic Care Model paradigm. The questionnaire is divided into five subscales to reflect the key components of the Chronic Care Model: patient activation, delivery system design & decision support, goal setting & tailoring, problem-solving & contextual, and follow-up/coordination. Each item has a score from 1 (never) to 5 (always). Patients self-report how often they received specific types of medical care during the past six months.
5. Glycemic control [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
   Hemoglobin A1c serum level

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: alex kopelowicz, MD; 747-210-4823; akopelowicz@mednet.ucla.edu

Contact: richard franco, BSN; 818-832-2505; rlfranco@mednet.ucla.edu

Locations

United States, California

Olive View-UCLA Medical Center; Recruiting

Sylmar, California, United States, 91342

Contact: alex kopelowicz 747-210-4823 akopelowicz@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: alex kopelowicz, MD; Olive View-UCLA Education & Research Institute

More Information

• Responsible Party: Alex Kopelowicz, M.D., Professor of Psychiatry, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03092063
• Other Study ID Numbers: 5R01NR015809 ( U.S. NIH Grant/Contract )
• First Posted: March 27, 2017
• Last Update Posted: October 22, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases