Improving Diabetes Outcomes: a 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. This is a study to develop and 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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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. This is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support. We believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes. The intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.Forty-five couples will be recruited in which one partner has type 2 diabetes. After initial testing and basic diabetes education, they will be assigned to one of three comparison groups. For those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques. A manual will include readings, structured homework assignments, and self-monitoring logs. They will be re-tested 2 weeks and 3 months after the intervention.

Official Title
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Improving Diabetes Outcomes: a Couples Intervention

Conditions
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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: greater than 21 years of age. diagnosed with type 2 diabetes for at least 1 year. have no severe complications (on dialysis, blindness, amputations, history of stroke) able to speak, read and hear English. married or cohabiting for > 1 year. have a telephone. Exclusion Criteria: have a diagnosed psychiatric disorder. refuse audiotaping or other study procedures.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 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<br>Telephone support and behavior change for couples | Behavioral: telephone support and behavior change<br>* Diabetes self-management education provided over the telephone either for individuals or couples<br>|
| Active Comparator: 2<br>Telephone support and behavior change for individuals | Behavioral: telephone support and behavior change<br>* Diabetes self-management education provided over the telephone either for individuals or couples<br>|
| Placebo Comparator: 3<br>Limited diabetes self-management education | 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 A1c) |  | 2 and 14 weeks post | 
| blood pressure |  | 2 and 14 weeks post | 
| diabetes regimen adherence |  | at 2 and 14 weeks post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipids |  | at 2 and 14 weeks post intervention | 
| weight/BMI |  | at 2 and 14 weeks post intervention | 
| food habits |  | at 2 and 14 weeks post intervention | 
| activity habits |  | at 2 and 14 weeks post intervention | 
| health-related quality of life |  | at 2 and 14 weeks post | 
| relationship quality |  | at 2 and 14 weeks post intervention | 
| diabetes self-efficacy |  | at 2 and 14 weeks post intervention | 

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