Trials / Completed
CompletedNCT00250731
Improving Diabetes Outcomes: a Couples Intervention
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- State University of New York - Upstate Medical University · Academic / Other
- Sex
- All
- Age
- 21 Years – 95 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | telephone support and behavior change | Diabetes self-management education provided over the telephone either for individuals or couples |
| OTHER | Diabetes self-management education | Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2005-11-08
- Last updated
- 2009-06-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00250731. Inclusion in this directory is not an endorsement.