Type2 Diabetes
Conditions
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.
Interventions
BEHAVIORALTomando 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.
BEHAVIORALTomando 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.
BEHAVIORALEnhanced 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
BEHAVIORALMultifamily 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Raters are blind to treatment condition.
Intervention model description
Diabetes Self-Management Education
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities) | 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
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Efficacy (Stanford Self-Efficacy Scale) | 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) | 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) | 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) | 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 | This outcome measure will be assessed at baseline, three months, six months and 12 months. | Hemoglobin A1c serum level |
Countries
United States
Outcome results
None listed