Improving Diabetes Outcomes: a Couples Intervention

NCT00250731 | Completed Phase 1 DMC

• 1 other identifier: 1R34DK06799501A2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Diabetes

Keywords

diabetes; relationship; social support; behavior change; telemedicine

Outcome Measures

Primary Outcomes (3)

• blood glucose control (hemoglobin A1c)

  2 and 14 weeks post

• blood pressure

  2 and 14 weeks post

• diabetes regimen adherence

  at 2 and 14 weeks post

Secondary Outcomes (7)

• lipids

  at 2 and 14 weeks post intervention

• weight/BMI

  at 2 and 14 weeks post intervention

• food habits

  at 2 and 14 weeks post intervention

• activity habits

  at 2 and 14 weeks post intervention

• health-related quality of life

  at 2 and 14 weeks post

Study Arms (3)

1

EXPERIMENTAL

Telephone support and behavior change for couples

Behavioral: telephone support and behavior change

2

ACTIVE COMPARATOR

Telephone support and behavior change for individuals

Behavioral: telephone support and behavior change

3

PLACEBO COMPARATOR

Limited diabetes self-management education

Other: Diabetes self-management education

Interventions

telephone support and behavior change BEHAVIORAL

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

1; 2

Diabetes self-management education OTHER

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

3

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• have a diagnosed psychiatric disorder.
• refuse audiotaping or other study procedures.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• National Institutes of Health (NIH): collaborator
• Syracuse University: collaborator

Study Sites (1)

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (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. 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

• 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

• 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

• 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

• 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 P, Sandberg JG, Ploutz-Snyder R, Brittain R, Cibula D, Scales K, Weinstock RS. Promoting couples collaboration in type 2 diabetes: the diabetes support project pilot data. Fam Syst Health. 2011 Sep;29(3):253-61. doi: 10.1037/a0024564.

  PMID: 21744962 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Paula M Trief, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: January 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

US (1)