Improving Diabetes Outcomes: a Couples Intervention

This study has been completed.
Sponsor:
Collaborators:
Syracuse University
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00250731
First received: November 7, 2005
Last updated: June 15, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Diabetes
Behavioral: telephone support and behavior change
Other: Diabetes self-management education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Diabetes Outcomes: a Couples Intervention

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • blood glucose control (hemoglobin A1c) [ Time Frame: 2 and 14 weeks post ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 2 and 14 weeks post ] [ Designated as safety issue: No ]
  • diabetes regimen adherence [ Time Frame: at 2 and 14 weeks post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lipids [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
  • weight/BMI [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
  • food habits [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
  • activity habits [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
  • health-related quality of life [ Time Frame: at 2 and 14 weeks post ] [ Designated as safety issue: No ]
  • relationship quality [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
  • diabetes self-efficacy [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250731

Locations
United States, New York
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Syracuse University
Investigators
Principal Investigator: Paula M Trief, PhD State University of New York - Upstate Medical University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paula M. Trief, PhD/Professor, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00250731     History of Changes
Other Study ID Numbers: 1R34DK06799501A2
Study First Received: November 7, 2005
Last Updated: June 15, 2009
Health Authority: United States: Federal Government

Keywords provided by State University of New York - Upstate Medical University:
diabetes
relationship
social support
behavior change
telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014