Diabetes Support Project: Couples Intervention

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Telephone support and behavior change; Other: Diabetes self-management education

• Registration Number: NCT01017523
• Lead Sponsor: State University of New York - Upstate Medical University

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.

Study Timeline

• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2 (Individual)	Telephone support and behavior change	Diabetes self-management education, telephone support and behavior change for individuals.
3 (Control)	Diabetes self-management education	Diabetes self-management education only.
1 (Couples)	Telephone support and behavior change	Diabetes self-management education, telephone support and behavior change for couples.

Primary Outcome Measures

Name	Time	Method
Blood glucose control (hemoglobin AIc)	Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

SUNY Upstate Medical University, Dept. of Psychiatry; 🇺🇸 Syracuse, New York, United States