Diabetes Support Project: Couples Intervention - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Behavioral: Telephone support and behavior change Other: Diabetes self-management education	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Improving Diabetes Outcome: The Diabetes Support Project

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:

Blood glucose control (hemoglobin AIc) [ Time Frame: Baseline, and 3 follow ups (mos 4, 8, 12) ] [ Designated as safety issue: No ]
Measures of behavior change (diet, physical activity) [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]
Diabetes-related quality of life outcome (distress) [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BMI/Waist circumference [ Time Frame: Baseline and 3 follow-ups (mos 4, 8, and 12) ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Diabetes self-management education, telephone support and behavior change for couples.	Behavioral: Telephone support and behavior change Diabetes self-management education provided over the telephone either for individual or couples
Active Comparator: 2 Diabetes self-management education, telephone support and behavior change for individuals.	Behavioral: Telephone support and behavior change Diabetes self-management education provided over the telephone either for individual or couples
Placebo Comparator: 3 Diabetes self-management education only.	Other: Diabetes self-management education Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017523

Contacts

Contact: Jacqueline A Dimmock, Ph.D.	315-464-3133	DimmockJ@upstate.edu
Contact: Paula M Trief, Ph.D.	315-464-1681	TriefP@upstate.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Danielle Hessler, Ph.D. 415-476-1925 HesslerD@fcm.ucsf.edu
Contact: Larry Fisher, Ph.D. 415-476-5403 fisherl@fcm.ucsf.edu
Principal Investigator: Larry Fisher, Ph.D.
United States, New York
SUNY Upstate Medical University, Dept. of Psychiatry	Recruiting
Syracuse, New York, United States, 13210
Contact: Jacqueline Dimmock, Ph.D.
Contact: Paula Trief, Ph.D. 315-464-1681 TriefP@upstate.edu
Principal Investigator: Paula M. Trief, Ph.D.

Sponsors and Collaborators

State University of New York - Upstate Medical University

Investigators

Principal Investigator:

Paula M Trief, Ph.D.

State University of New York - Upstate Medical University

More Information

Publications:

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.

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.

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.

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, 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, 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.

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. No abstract available.

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.

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

Responsible Party:	Paula Trief, Ph.D., Professor of Psychiatry and Medicine, SUNY Upstate Medical University, Dept. of Psychiatry
ClinicalTrials.gov Identifier:	NCT01017523 History of Changes
Other Study ID Numbers:	5840
Study First Received:	November 18, 2009
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:

diabetes
relationship
social support
telemedicine

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

Diabetes Support Project: Couples Intervention (DSP)