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Completed

NCT Number: NCT01017523

Diabetes Support Project: 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. The purpose of this study is to 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

Diabetes is a serious illness that affects an estimated 7% of the US population, and is associated with life-threatening and disabling complications. Research has shown that diabetes affects both the patient and family, and that support from one's spouse has been found to be the most important source of support during illness episodes. Research clearly shows that marital interaction, i.e., how the support is given and received, impacts both marital quality and health functioning. Despite the acknowledged importance of social support, the vast majority of chronic illness interventions target the individual patient. Telephone counseling has been effectively used to enhance feasibility and target patients with many illnesses, and has many benefits including low cost, decreased subject burden, and the ability to reach a broader population. This study proposes a study of a telephone-administered behavior change that promotes couples communication and collaboration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 2 diabetes
  • A1c level is >=7.5%
  • Age of target subject and spouse/partner is 21 years or older
  • Married or together for > 1 year
  • Able to speak, read, and hear English
  • Have a telephone

Exclusion criteria

  • History of diabetes-related medical complications
  • History of active psychosis or dementia

Treatment and study plan

Telephone support and behavior change

Behavioral

Diabetes self-management education provided over the telephone either for individual 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 AIc)

    Time frame: Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary outcomes

  1. BMI/Waist circumference

    Time frame: Baseline and 3 follow-ups (mos 4, 8, and 12)

  2. Measures of behavior change (diet, physical activity)

    Time frame: Baseline and 3 follow-ups (mos 4, 8, and 12)

  3. Diabetes-related quality of life outcome (distress)

    Time frame: Baseline and 3 follow-ups (mos 4, 8, and 12)

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Improving Diabetes Outcome: The Diabetes Support Project

Acronym: DSP

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2009
Registry last updated
May 22, 2015

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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