Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALtelephone support and behavior changeDiabetes self-management education provided over the telephone either for individuals or couples
OTHERDiabetes self-management educationLimited 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.