Diabetes Support Project: Couples Intervention (DSP)

May 21, 2015 updated by: Paula Trief, State University of New York - Upstate Medical University

Improving Diabetes Outcome: The Diabetes Support Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University, Dept. of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 (Couples)
Diabetes self-management education, telephone support and behavior change for couples.
Behavioral: Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual or couples
Active Comparator: 2 (Individual)
Diabetes self-management education, telephone support and behavior change for individuals.
Behavioral: Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual or couples
Placebo Comparator: 3 (Control)
Diabetes self-management education only.
Other: Diabetes self-management education
Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose control (hemoglobin AIc)
Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12)
Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary Outcome Measures

Outcome Measure
Time Frame
BMI/Waist circumference
Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12)
Baseline and 3 follow-ups (mos 4, 8, and 12)
Measures of behavior change (diet, physical activity)
Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12)
Baseline and 3 follow-ups (mos 4, 8, and 12)
Diabetes-related quality of life outcome (distress)
Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12)
Baseline and 3 follow-ups (mos 4, 8, and 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Collaborators

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

Investigators

  • Principal Investigator: Paula M Trief, Ph.D., State University of New York - Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5840 (CTEP)
  • R18DK080867 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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