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

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tomando Control-Nurse
Tomando Control-Promotora
Enhanced engagement
Multifamily Group
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Olive View-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Tomando Control-Nurse

Tomando Control-Promotora

Enhanced Engagement-Nurse

Enhanced Engagement-Promotora

Multifamily Group-Promotora

Multifamily Group-Nurses

Arm 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diabetes Self-Efficacy (Stanford Self-Efficacy Scale)
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.
Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale)
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.
Family Support (Diabetes Family Support Behavior Checklist)
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.
Collaborative goal setting (Patient Assessment of Chronic Illness Care)
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.
Glycemic control
Hemoglobin A1c serum level

Full Information

First Posted
March 10, 2017
Last Updated
September 28, 2021
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03092063
Brief Title
Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes
Official Title
Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Diabetes Self-Management Education
Masking
Outcomes Assessor
Masking Description
Raters are blind to treatment condition.
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tomando Control-Nurse
Arm Type
Experimental
Arm 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.
Arm Title
Tomando Control-Promotora
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Engagement-Nurse
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Engagement-Promotora
Arm Type
Experimental
Arm 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.
Arm Title
Multifamily Group-Promotora
Arm Type
Experimental
Arm 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.
Arm Title
Multifamily Group-Nurses
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Tomando Control-Nurse
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tomando Control-Promotora
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced engagement
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Multifamily Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Diabetes Self-Efficacy (Stanford Self-Efficacy Scale)
Description
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.
Time Frame
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Title
Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale)
Description
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.
Time Frame
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Title
Family Support (Diabetes Family Support Behavior Checklist)
Description
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.
Time Frame
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Title
Collaborative goal setting (Patient Assessment of Chronic Illness Care)
Description
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.
Time Frame
This outcome measure will be assessed at baseline, three months, six months and 12 months.
Title
Glycemic control
Description
Hemoglobin A1c serum level
Time Frame
This outcome measure will be assessed at baseline, three months, six months and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: diagnosis of Type 1 diabetes participation in another Diabetes Self-management education program within the past 12 months pregnancy significant cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alex kopelowicz, MD
Organizational Affiliation
Olive View-UCLA Education & Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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