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Clinical Trials/NCT00250731
NCT00250731
Completed
Phase 1

Improving Diabetes Outcomes: a Couples Intervention

State University of New York - Upstate Medical University1 site in 1 country45 target enrollmentJanuary 2006
ConditionsDiabetes

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes
Sponsor
State University of New York - Upstate Medical University
Enrollment
45
Locations
1
Primary Endpoint
blood glucose control (hemoglobin A1c)
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
February 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • have a diagnosed psychiatric disorder.
  • refuse audiotaping or other study procedures.

Outcomes

Primary Outcomes

blood glucose control (hemoglobin A1c)

Time Frame: 2 and 14 weeks post

blood pressure

Time Frame: 2 and 14 weeks post

diabetes regimen adherence

Time Frame: at 2 and 14 weeks post

Secondary Outcomes

  • 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)

Study Sites (1)

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