ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Support Project: Couples Intervention (DSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01017523
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 22, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Paula Trief, State University of New York - Upstate Medical University

November 18, 2009
November 20, 2009
May 22, 2015
January 2010
January 2015   (Final data collection date for primary outcome measure)
Blood glucose control (hemoglobin AIc) [ Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12) ]
  • Blood glucose control (hemoglobin AIc) [ Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12) ]
  • Measures of behavior change (diet, physical activity) [ Time Frame: 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) ]
Complete list of historical versions of study NCT01017523 on ClinicalTrials.gov Archive Site
  • BMI/Waist circumference [ Time Frame: 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) ]
  • Diabetes-related quality of life outcome (distress) [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ]
BMI/Waist circumference [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ]
Not Provided
Not Provided
 
Diabetes Support Project: Couples Intervention
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Behavioral: Telephone support and behavior change
    Diabetes self-management education provided over the telephone either for individual or couples
  • Other: Diabetes self-management education
    Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
  • Experimental: 1 (Couples)
    Diabetes self-management education, telephone support and behavior change for couples.
    Intervention: Behavioral: Telephone support and behavior change
  • Active Comparator: 2 (Individual)
    Diabetes self-management education, telephone support and behavior change for individuals.
    Intervention: Behavioral: Telephone support and behavior change
  • Placebo Comparator: 3 (Control)
    Diabetes self-management education only.
    Intervention: Other: Diabetes self-management education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
320
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01017523
5840
R18DK080867 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Paula Trief, State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Paula M Trief, Ph.D. State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP