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Diabetes Support Project: Couples Intervention

Improving Diabetes Outcome: The Diabetes Support Project

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01017523
Acronym
DSP
Enrollment
268
Registered
2009-11-20
Start date
2010-01-31
Completion date
2015-01-31
Last updated
2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

diabetes, relationship, social support, telemedicine

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.

Interventions

Diabetes self-management education provided over the telephone either for individual or couples

Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood glucose control (hemoglobin AIc)Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary

MeasureTime frame
BMI/Waist circumferenceBaseline 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)
Diabetes-related quality of life outcome (distress)Baseline and 3 follow-ups (mos 4, 8, and 12)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026