Improving Diabetes Outcomes: a Couples Intervention

NCT ID: NCT00250731

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-02-28

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.

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Telephone support and behavior change for couples

Group Type: EXPERIMENTAL

telephone support and behavior change

Intervention Type: BEHAVIORAL

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

2

Telephone support and behavior change for individuals

Group Type: ACTIVE_COMPARATOR

telephone support and behavior change

Intervention Type: BEHAVIORAL

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

3

Limited diabetes self-management education

Group Type: PLACEBO_COMPARATOR

Diabetes self-management education

Intervention Type: OTHER

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

Interventions

telephone support and behavior change

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

Intervention Type: BEHAVIORAL

Diabetes self-management education

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Syracuse University

OTHER

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

SUNY Upstate Medical University

Principal Investigators

Paula M Trief, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

State University of New York Upstate Medical University

Syracuse, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12941736 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11423517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9830956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11439708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11473074 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12087013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15184090 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21744962 (View on PubMed)

Other Identifiers

1R34DK06799501A2

Identifier Type: -

Identifier Source: org_study_id