Clinical trial NCT00714441: Reducing Distress and Improving Self-Care in Diabetes
Official title: Reducing Distress and Improving Self-Care in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes Type 2
Distress
Problem Solving Therapy
Computer Automated Self-Management (CASM)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-07-14
Enrollment: 392
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.

Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.

Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
* Be between 21 and 75 years of age
* Speak and read Spanish or English fluently
* In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score \> 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
* Have access to the internet

Exclusion Criteria:

* Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
* Have current MDD (based on the PHQ8).

Primary outcomes:
measure: Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.
timeFrame: Baseline, 16 weeks, and 12 months
measure: Physical Activity. The CHAMPS (28 items) will be used to measure physical activity.
timeFrame: Baseline, 16 weeks, and 12 months
measure: Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use.
timeFrame: Baseline, 16 weeks, and 12 months
measure: Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis.
timeFrame: Baseline, 16 weeks, and 12 months
Secondary outcomes:
measure: HbA1C
timeFrame: Baseline, 16 weeks, and 12 months
measure: Blood Pressure
timeFrame: Baseline, 16 weeks, and 12 months
measure: Fasting glucose
timeFrame: Baseline, 16 weeks, and 12 months
measure: Lipids
timeFrame: Baseline, 16 weeks, and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UC San Francisco, Family and Community Medicine Dept.
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lawrence Fisher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
citation: Fisher L, Skaff MM, Mullan JT, Arean P, Mohr D, Masharani U, Glasgow R, Laurencin G. Clinical depression versus distress among patients with type 2 diabetes: not just a question of semantics. Diabetes Care. 2007 Mar;30(3):542-8. doi: 10.2337/dc06-1614.
citation: Glasgow RE, Fisher L, Skaff M, Mullan J, Toobert DJ. Problem solving and diabetes self-management: investigation in a large, multiracial sample. Diabetes Care. 2007 Jan;30(1):33-7. doi: 10.2337/dc06-1390.
citation: Arean PA, Perri MG, Nezu AM, Schein RL, Christopher F, Joseph TX. Comparative effectiveness of social problem-solving therapy and reminiscence therapy as treatments for depression in older adults. J Consult Clin Psychol. 1993 Dec;61(6):1003-10. doi: 10.1037//0022-006x.61.6.1003.
citation: Glasgow RE, Klesges LM, Dzewaltowski DA, Estabrooks PA, Vogt TM. Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues. Health Educ Res. 2006 Oct;21(5):688-94. doi: 10.1093/her/cyl081. Epub 2006 Aug 31.
citation: Glasgow RE, Strycker LA, King DK, Toobert DJ, Rahm AK, Jex M, Nutting PA. Robustness of a computer-assisted diabetes self-management intervention across patient characteristics, healthcare settings, and intervention staff. Am J Manag Care. 2006 Mar;12(3):137-45.
citation: Fisher L, Mullan JT, Skaff MM, Glasgow RE, Arean P, Hessler D. Predicting diabetes distress in patients with Type 2 diabetes: a longitudinal study. Diabet Med. 2009 Jun;26(6):622-7. doi: 10.1111/j.1464-5491.2009.02730.x.
citation: Hessler D, Fisher L, Glasgow RE, Strycker LA, Dickinson LM, Arean PA, Masharani U. Reductions in regimen distress are associated with improved management and glycemic control over time. Diabetes Care. 2014;37(3):617-24. doi: 10.2337/dc13-0762. Epub 2013 Oct 29.
citation: Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, Strycker LA. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care. 2013 Sep;36(9):2551-8. doi: 10.2337/dc12-2493. Epub 2013 Jun 4.