Diabetes Support Project: Couples Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Diabetes Outcome: The Diabetes Support Project

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Telephone support and behavior change
* Other: Diabetes self-management education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (Couples)<br>Diabetes self-management education, telephone support and behavior change for couples. | Behavioral: Telephone support and behavior change<br>* Diabetes self-management education provided over the telephone either for individual or couples<br>|
| Active Comparator: 2 (Individual)<br>Diabetes self-management education, telephone support and behavior change for individuals. | Behavioral: Telephone support and behavior change<br>* Diabetes self-management education provided over the telephone either for individual or couples<br>|
| Placebo Comparator: 3 (Control)<br>Diabetes self-management education only. | Other: Diabetes self-management education<br>* Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose control (hemoglobin AIc) |  | Baseline, and 3 follow ups (mos 4, 8, 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI/Waist circumference |  | 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) | 
| Diabetes-related quality of life outcome (distress) |  | Baseline and 3 follow-ups (mos 4, 8, and 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, relationship, social support, telemedicine