Improving Diabetes Outcomes: a Couples Intervention
- Conditions
- Diabetes
- Interventions
- Behavioral: telephone support and behavior changeOther: Diabetes self-management education
- Registration Number
- NCT00250731
- Lead Sponsor
- State University of New York - Upstate Medical University
- Brief Summary
Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a study to develop and test an intervention that helps partners and patients who have type 2 diabetes better support each other. The intervention will be delivered over the telephone to reach more people. Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.
- Detailed Description
Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support. We believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes. The intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.Forty-five couples will be recruited in which one partner has type 2 diabetes. After initial testing and basic diabetes education, they will be assigned to one of three comparison groups. For those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques. A manual will include readings, structured homework assignments, and self-monitoring logs. They will be re-tested 2 weeks and 3 months after the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- greater than 21 years of age.
- diagnosed with type 2 diabetes for at least 1 year.
- have no severe complications (on dialysis, blindness, amputations, history of stroke)
- able to speak, read and hear English.
- married or cohabiting for > 1 year.
- have a telephone.
- have a diagnosed psychiatric disorder.
- refuse audiotaping or other study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 telephone support and behavior change Telephone support and behavior change for couples 2 telephone support and behavior change Telephone support and behavior change for individuals 3 Diabetes self-management education Limited diabetes self-management education
- Primary Outcome Measures
Name Time Method blood pressure 2 and 14 weeks post blood glucose control (hemoglobin A1c) 2 and 14 weeks post diabetes regimen adherence at 2 and 14 weeks post
- Secondary Outcome Measures
Name Time Method lipids at 2 and 14 weeks post intervention weight/BMI at 2 and 14 weeks post intervention food habits at 2 and 14 weeks post intervention activity habits at 2 and 14 weeks post intervention health-related quality of life at 2 and 14 weeks post relationship quality at 2 and 14 weeks post intervention diabetes self-efficacy at 2 and 14 weeks post intervention
Trial Locations
- Locations (1)
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States