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Improving Diabetes Outcomes: a Couples Intervention

Improving Diabetes Outcomes: a Couples Intervention

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00250731
Enrollment
45
Registered
2005-11-08
Start date
2006-01-31
Completion date
2009-02-28
Last updated
2009-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

diabetes, relationship, social support, behavior change, telemedicine

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.

Interventions

Diabetes self-management education provided over the telephone either for individuals or couples

Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Syracuse University
CollaboratorOTHER
State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
blood glucose control (hemoglobin A1c)2 and 14 weeks post
blood pressure2 and 14 weeks post
diabetes regimen adherenceat 2 and 14 weeks post

Secondary

MeasureTime frame
activity habitsat 2 and 14 weeks post intervention
health-related quality of lifeat 2 and 14 weeks post
lipidsat 2 and 14 weeks post intervention
diabetes self-efficacyat 2 and 14 weeks post intervention
relationship qualityat 2 and 14 weeks post intervention
weight/BMIat 2 and 14 weeks post intervention
food habitsat 2 and 14 weeks post intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026