Diabetes Support Project: Couples Intervention

NCT01017523 | Completed Phase 3

• 2 other identifiers: 5840R18DK080867
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes

Keywords

diabetes; relationship; social support; telemedicine

Outcome Measures

Primary Outcomes (1)

• Blood glucose control (hemoglobin AIc)

  Baseline, and 3 follow ups (mos 4, 8, 12)

Secondary Outcomes (3)

• BMI/Waist circumference

  Baseline and 3 follow-ups (mos 4, 8, and 12)

• Measures of behavior change (diet, physical activity)

  Baseline and 3 follow-ups (mos 4, 8, and 12)

• Diabetes-related quality of life outcome (distress)

  Baseline and 3 follow-ups (mos 4, 8, and 12)

Study Arms (3)

1 (Couples)

EXPERIMENTAL

Diabetes self-management education, telephone support and behavior change for couples.

Behavioral: Telephone support and behavior change

2 (Individual)

ACTIVE COMPARATOR

Diabetes self-management education, telephone support and behavior change for individuals.

Behavioral: Telephone support and behavior change

3 (Control)

PLACEBO COMPARATOR

Diabetes self-management education only.

Other: Diabetes self-management education

Interventions

Telephone support and behavior change BEHAVIORAL

Diabetes self-management education provided over the telephone either for individual or couples

1 (Couples); 2 (Individual)

Diabetes self-management education OTHER

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

3 (Control)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of diabetes-related medical complications
• History of active psychosis or dementia

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

SUNY Upstate Medical University, Dept. of Psychiatry

Syracuse, New York, 13210, United States

Location

Related Publications (12)

• 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.

  PMID: 9830956 BACKGROUND

• 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.

  PMID: 10923558 BACKGROUND

• 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.

  PMID: 9539989 BACKGROUND

• 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.

  PMID: 15184090 BACKGROUND

• 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.

  PMID: 11473074 BACKGROUND

• 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.

  PMID: 12087013 BACKGROUND

• 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.

  PMID: 12941736 BACKGROUND

• 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.

  PMID: 11423517 BACKGROUND

• 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.

  PMID: 11439708 BACKGROUND

• 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.

  PMID: 31653476 DERIVED

• 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.

  PMID: 30485516 DERIVED

• 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.

  PMID: 27456837 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paula M Trief, Ph.D.

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Medicine

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 20, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (2)