Improving Diabetes Outcomes: a Couples Intervention
Study Details
Study Description
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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Telephone support and behavior change for couples |
Behavioral: telephone support and behavior change
Diabetes self-management education provided over the telephone either for individuals or couples
|
| Active Comparator: 2 Telephone support and behavior change for individuals |
Behavioral: telephone support and behavior change
Diabetes self-management education provided over the telephone either for individuals or couples
|
| Placebo Comparator: 3 Limited diabetes self-management education |
Other: Diabetes self-management education
Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
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married or cohabiting for > 1 year.
-
have a telephone.
Exclusion Criteria:
-
have a diagnosed psychiatric disorder.
-
refuse audiotaping or other study procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
Sponsors and Collaborators
- State University of New York - Upstate Medical University
- National Institutes of Health (NIH)
- Syracuse University
Investigators
- Principal Investigator: Paula M Trief, PhD, State University of New York - Upstate Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- Delamater AM, Jacobson AM, Anderson B, Cox D, Fisher L, Lustman P, Rubin R, Wysocki T; Psychosocial Therapies Working Group. Psychosocial therapies in diabetes: report of the Psychosocial Therapies Working Group. Diabetes Care. 2001 Jul;24(7):1286-92. Review.
- Fisher L, Chesla CA, Bartz RJ, Gilliss C, Skaff MA, Sabogal F, Kanter RA, Lutz CP. The family and type 2 diabetes: a framework for intervention. Diabetes Educ. 1998 Sep-Oct;24(5):599-607. Review.
- Garfield SA, Malozowski S, Chin MH, Narayan KM, Glasgow RE, Green LW, Hiss RG, Krumholz HM; Diabetes Mellitus Interagency Coordinating Committee (DIMCC) Translation Conference Working Group. Considerations for diabetes translational research in real-world settings. Diabetes Care. 2003 Sep;26(9):2670-4. Review.
- Kiecolt-Glaser JK, Newton TL. Marriage and health: his and hers. Psychol Bull. 2001 Jul;127(4):472-503. Review.
- Trief PM, Himes CL, Orendorff R, Weinstock RS. The marital relationship and psychosocial adaptation and glycemic control of individuals with diabetes. Diabetes Care. 2001 Aug;24(8):1384-9.
- Trief PM, Ploutz-Snyder R, Britton KD, Weinstock RS. The relationship between marital quality and adherence to the diabetes care regimen. Ann Behav Med. 2004 Jun;27(3):148-54.
- Trief PM, Wade MJ, Britton KD, Weinstock RS. A prospective analysis of marital relationship factors and quality of life in diabetes. Diabetes Care. 2002 Jul;25(7):1154-8.
- 1R34DK06799501A2