Diabetes Support Project: Couples Intervention

Type 2 Diabetes Clinical Trial

— DSP  

Official title:

Improving Diabetes Outcome: The Diabetes Support Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017523
• Other study ID #: 5840
• Secondary ID: R18DK080867
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2009
• Last updated: May 21, 2015
• Start date: January 2010
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual 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	University of California, San Francisco	San Francisco	California
United States	SUNY Upstate Medical University, Dept. of Psychiatry	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

Fisher L, Weihs KL. Can addressing family relationships improve outcomes in chronic disease? Report of the National Working Group on Family-Based Interventions in Chronic Disease. J Fam Pract. 2000 Jun;49(6):561-6. 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, Grant W, Elbert K, Weinstock RS. Family environment, glycemic control, and the psychosocial adaptation of adults with diabetes. Diabetes Care. 1998 Feb;21(2):241-5. — 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 AIc)		Baseline, and 3 follow ups (mos 4, 8, 12)	No
Secondary	BMI/Waist circumference		Baseline and 3 follow-ups (mos 4, 8, and 12)	No
Secondary	Measures of behavior change (diet, physical activity)		Baseline and 3 follow-ups (mos 4, 8, and 12)	No
Secondary	Diabetes-related quality of life outcome (distress)		Baseline and 3 follow-ups (mos 4, 8, and 12)	No