Diabetes Support Project: Couples Intervention (DSP)

State University of New York - Upstate Medical University

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Behavioral: Telephone support and behavior change; Other: Diabetes self-management education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01017523

R18DK080867 (U.S. NIH Grant/Contract)

5840 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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268 participants in 3 patient groups, including a placebo group

1 (Couples)

Experimental group

Description:

Diabetes self-management education, telephone support and behavior change for couples.

Treatment:

Behavioral: Telephone support and behavior change

2 (Individual)

Active Comparator group

Description:

Diabetes self-management education, telephone support and behavior change for individuals.

Treatment:

Behavioral: Telephone support and behavior change

3 (Control)

Placebo Comparator group

Description:

Diabetes self-management education only.

Treatment:

Other: Diabetes self-management education