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Completed

NCT Number: NCT00250731

Improving Diabetes Outcomes: a Couples Intervention

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.

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Key information

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone support and behavior change

Behavioral

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

Diabetes self-management education

Other

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

Primary outcomes

  1. blood glucose control (hemoglobin A1c)

    Time frame: 2 and 14 weeks post

  2. blood pressure

    Time frame: 2 and 14 weeks post

  3. diabetes regimen adherence

    Time frame: at 2 and 14 weeks post

Secondary outcomes

  1. lipids

    Time frame: at 2 and 14 weeks post intervention

  2. weight/BMI

    Time frame: at 2 and 14 weeks post intervention

  3. food habits

    Time frame: at 2 and 14 weeks post intervention

  4. activity habits

    Time frame: at 2 and 14 weeks post intervention

  5. health-related quality of life

    Time frame: at 2 and 14 weeks post

  6. relationship quality

    Time frame: at 2 and 14 weeks post intervention

  7. diabetes self-efficacy

    Time frame: at 2 and 14 weeks post intervention

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

  • National Institutes of Health (NIH)
  • Syracuse University

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 8, 2005
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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