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Diabetes Support Project: Couples Intervention (DSP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paula Trief, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01017523
First received: November 18, 2009
Last updated: November 17, 2014
Last verified: November 2014
  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. 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.


Condition Intervention Phase
Type 2 Diabetes
Behavioral: Telephone support and behavior change
Other: Diabetes self-management education
Phase 3

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 Outcome: The Diabetes Support Project

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 AIc) [ Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12) ] [ Designated as safety issue: No ]
  • Measures of behavior change (diet, physical activity) [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]
  • Diabetes-related quality of life outcome (distress) [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI/Waist circumference [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01017523

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, New York
SUNY Upstate Medical University, Dept. of Psychiatry
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Paula M Trief, Ph.D. State University of New York - Upstate Medical University
  More Information

Publications:

Responsible Party: Paula Trief, Professor of Psychiatry and Medicine, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01017523     History of Changes
Other Study ID Numbers: 5840
Study First Received: November 18, 2009
Last Updated: November 17, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014