Improving Diabetes Outcomes: a Couples Intervention

Diabetes Clinical Trial

Official title:

Improving Diabetes Outcomes: a Couples Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250731
• Other study ID #: 1R34DK06799501A2
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2005
• Last updated: June 15, 2009
• Start date: January 2006
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• telephone support and behavior change
Diabetes self-management education provided over the telephone either for individuals or couples

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

Locations

Country	Name	City	State
United States	State University of New York Upstate Medical University	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	National Institutes of Health (NIH), Syracuse University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Kiecolt-Glaser JK, Newton TL. Marriage and health: his and hers. Psychol Bull. 2001 Jul;127(4):472-503. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose control (hemoglobin A1c)		2 and 14 weeks post	No
Primary	blood pressure		2 and 14 weeks post	No
Primary	diabetes regimen adherence		at 2 and 14 weeks post	No
Secondary	lipids		at 2 and 14 weeks post intervention	No
Secondary	weight/BMI		at 2 and 14 weeks post intervention	No
Secondary	food habits		at 2 and 14 weeks post intervention	No
Secondary	activity habits		at 2 and 14 weeks post intervention	No
Secondary	health-related quality of life		at 2 and 14 weeks post	No
Secondary	relationship quality		at 2 and 14 weeks post intervention	No
Secondary	diabetes self-efficacy		at 2 and 14 weeks post intervention	No