Study Results
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Basic Information
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COMPLETED
PHASE3
268 participants
INTERVENTIONAL
2010-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1 (Couples)
Diabetes self-management education, telephone support and behavior change for couples.
Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual or couples
2 (Individual)
Diabetes self-management education, telephone support and behavior change for individuals.
Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual or couples
3 (Control)
Diabetes self-management education only.
Diabetes self-management education
Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
Interventions
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Telephone support and behavior change
Diabetes self-management education provided over the telephone either for individual or couples
Diabetes self-management education
Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
Eligibility Criteria
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Inclusion Criteria
* 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 active psychosis or dementia
21 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
State University of New York - Upstate Medical University
OTHER
Responsible Party
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Paula Trief
Professor of Psychiatry and Medicine
Principal Investigators
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Paula M Trief, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Locations
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University of California, San Francisco
San Francisco, California, United States
SUNY Upstate Medical University, Dept. of Psychiatry
Syracuse, New York, United States
Countries
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References
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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. doi: 10.1177/014572179802400504.
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.
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. doi: 10.2337/diacare.21.2.241.
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. doi: 10.1207/s15324796abm2703_2.
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. doi: 10.2337/diacare.24.8.1384.
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. doi: 10.2337/diacare.25.7.1154.
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. doi: 10.2337/diacare.26.9.2670. 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. doi: 10.2337/diacare.24.7.1286.
Kiecolt-Glaser JK, Newton TL. Marriage and health: his and hers. Psychol Bull. 2001 Jul;127(4):472-503. doi: 10.1037/0033-2909.127.4.472.
Yorgason JB, Sandberg JG, Weinstock RS, Trief PM, Fisher L, Hessler D. The importance of relationship processes for lowering BMI over time in women with type 2 diabetes in a randomized controlled trial. Obes Res Clin Pract. 2019 Nov-Dec;13(6):599-601. doi: 10.1016/j.orcp.2019.08.003. Epub 2019 Oct 22.
Trief PM, Fisher L, Sandberg J, Hessler DM, Cibula DA, Weinstock RS. Two for one? Effects of a couples intervention on partners of persons with Type 2 diabetes: a randomized controlled trial. Diabet Med. 2019 Apr;36(4):473-481. doi: 10.1111/dme.13871. Epub 2019 Jan 8.
Trief PM, Fisher L, Sandberg J, Cibula DA, Dimmock J, Hessler DM, Forken P, Weinstock RS. Health and Psychosocial Outcomes of a Telephonic Couples Behavior Change Intervention in Patients With Poorly Controlled Type 2 Diabetes: A Randomized Clinical Trial. Diabetes Care. 2016 Dec;39(12):2165-2173. doi: 10.2337/dc16-0035. Epub 2016 Jul 25.
Other Identifiers
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5840
Identifier Type: -
Identifier Source: org_study_id
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