Improving Diabetes Outcomes: a Couples Intervention
Improving Diabetes Outcomes: a Couples Intervention
This study is currently recruiting participants.
Verified by State University of New York - Upstate Medical University, October 2008
Sponsors and Collaborators: State University of New York - Upstate Medical University
National Institutes of Health (NIH)
Syracuse University
Information provided by: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00250731
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. 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 Intervention Phase
Diabetes
Behavioral: telephone support and behavior change
Other: Diabetes self-management education
Phase I
MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title:Improving Diabetes Outcomes: a Couples Intervention
Further study details as provided by State University of New York - Upstate Medical University:
Primary Outcome Measures:
blood glucose control (hemoglobin A1c) [ Time Frame: 2 and 14 weeks post ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: 2 and 14 weeks post ] [ Designated as safety issue: No ]
diabetes regimen adherence [ Time Frame: at 2 and 14 weeks post ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
lipids [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
weight/BMI [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
food habits [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
activity habits [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
health-related quality of life [ Time Frame: at 2 and 14 weeks post ] [ Designated as safety issue: No ]
relationship quality [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
diabetes self-efficacy [ Time Frame: at 2 and 14 weeks post intervention ] [ Designated as safety issue: No ]
Estimated Enrollment:45
Study Start Date:January 2006
Estimated Study Completion Date:December 2008
Estimated Primary Completion Date:December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Active Comparator
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
3: Placebo Comparator
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
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.
Eligibility
Ages Eligible for Study:21 Years to 95 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250731
Contacts
Contact: Jennifer Hartsig, BS 315.464.5724 hartsigj@upstate.edu
Contact: Kelly Duncan, BA 315.464.3878 duncank@upstate.edu
Locations
United States, New York
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Paula M Trief, PhD
Sub-Investigator: Ruth S Weinstock, MD, PhD
Sub-Investigator: Jonathan Sandberg, PhD
Sub-Investigator: Robert Ploutz-Snyder, PhD
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
Publications:
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.
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.
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, 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.
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.
Responsible Party:SUNY Upstate Medical University ( Paula M. Trief, PhD/Professor )
Study ID Numbers:1R34DK06799501A2
First Received:November 7, 2005
Last Updated:October 28, 2008
ClinicalTrials.gov Identifier:NCT00250731 [history]
Health Authority:United States: Federal Government
Keywords provided by State University of New York - Upstate Medical University:
diabetes
relationship
social support
behavior change
telemedicine
Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
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