Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092063
Recruitment Status : Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Alex Kopelowicz, M.D., University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE March 10, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • Glycemic control [ Time Frame: This outcome measure will be assessed at baseline, three months, six months and 12 months. ]
    Hemoglobin A1c serum level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes
Official Title  ICMJE Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Tomando Control-Nurse
  • 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.
    Intervention: Behavioral: Tomando Control-Promotora
  • 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.
    Interventions:
    • Behavioral: Tomando Control-Nurse
    • Behavioral: Enhanced engagement
  • 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.
    Interventions:
    • Behavioral: Tomando Control-Promotora
    • Behavioral: Enhanced engagement
  • 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.
    Interventions:
    • Behavioral: Tomando Control-Promotora
    • Behavioral: Multifamily Group
  • 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.
    Interventions:
    • Behavioral: Tomando Control-Nurse
    • Behavioral: Multifamily Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03092063
Other Study ID Numbers  ICMJE 5R01NR015809( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alex Kopelowicz, M.D., University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: alex kopelowicz, MD Olive View-UCLA Education & Research Institute
PRS Account University of California, Los Angeles
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP