Improving Diabetes Outcomes: a Couples Intervention

June 15, 2009 updated by: State University of New York - Upstate Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

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
    • New York
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Telephone support and behavior change for couples
Behavioral: telephone support and behavior change
Diabetes self-management education provided over the telephone either for individuals or couples
Active Comparator: 2
Telephone support and behavior change for individuals
Behavioral: telephone support and behavior change
Diabetes self-management education provided over the telephone either for individuals or couples
Placebo Comparator: 3
Limited diabetes self-management education
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 A1c)
Time Frame: 2 and 14 weeks post
2 and 14 weeks post
blood pressure
Time Frame: 2 and 14 weeks post
2 and 14 weeks post
diabetes regimen adherence
Time Frame: at 2 and 14 weeks post
at 2 and 14 weeks post

Secondary Outcome Measures

Outcome Measure
Time Frame
lipids
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
weight/BMI
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
food habits
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
activity habits
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
health-related quality of life
Time Frame: at 2 and 14 weeks post
at 2 and 14 weeks post
relationship quality
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
diabetes self-efficacy
Time Frame: at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention

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 Institutes of Health (NIH)
Syracuse University

Investigators

  • Principal Investigator: Paula M Trief, PhD, 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, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 7, 2005

First Submitted That Met QC Criteria

November 7, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34DK06799501A2

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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