Clinical trial NCT00250731: Improving Diabetes Outcomes: a Couples Intervention
Official title: Improving Diabetes Outcomes: a Couples Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: diabetes
relationship
social support
behavior change
telemedicine
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Syracuse University
First posted: 2005-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: blood glucose control (hemoglobin A1c)
timeFrame: 2 and 14 weeks post
measure: blood pressure
timeFrame: 2 and 14 weeks post
measure: diabetes regimen adherence
timeFrame: at 2 and 14 weeks post
Secondary outcomes:
measure: lipids
timeFrame: at 2 and 14 weeks post intervention
measure: weight/BMI
timeFrame: at 2 and 14 weeks post intervention
measure: food habits
timeFrame: at 2 and 14 weeks post intervention
measure: activity habits
timeFrame: at 2 and 14 weeks post intervention
measure: health-related quality of life
timeFrame: at 2 and 14 weeks post
measure: relationship quality
timeFrame: at 2 and 14 weeks post intervention
measure: diabetes self-efficacy
timeFrame: at 2 and 14 weeks post intervention
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: State University of New York Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Paula M Trief, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.