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Clinical Trials/NCT01017523
NCT01017523
Completed
Phase 3

Improving Diabetes Outcome: The Diabetes Support Project

State University of New York - Upstate Medical University2 sites in 1 country268 target enrollmentJanuary 2010
ConditionsType 2 Diabetes

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
State University of New York - Upstate Medical University
Enrollment
268
Locations
2
Primary Endpoint
Blood glucose control (hemoglobin AIc)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University
Responsible Party
Principal Investigator
Principal Investigator

Paula Trief

Professor of Psychiatry and Medicine

State University of New York - Upstate Medical University

Eligibility 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

Outcomes

Primary Outcomes

Blood glucose control (hemoglobin AIc)

Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary Outcomes

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

Study Sites (2)

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