Improving Diabetes Outcomes: a Couples Intervention

State University of New York - Upstate Medical University

Status and phase: Completed; Phase 1

Conditions: Diabetes

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00250731

1R34DK06799501A2

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. 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.

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Telephone support and behavior change for couples

Treatment:

Behavioral: telephone support and behavior change

2

Active Comparator group

Description:

Telephone support and behavior change for individuals

Treatment:

Behavioral: telephone support and behavior change

3

Placebo Comparator group

Description:

Limited diabetes self-management education

Treatment:

Other: Diabetes self-management education