Diabetes Type 2
Conditions
Keywords
Diabetes Type 2, Distress, Problem Solving Therapy, Computer Automated Self-Management (CASM)
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.
Interventions
BEHAVIORALLifestyle and Activities Education Program (LEAP-AHEAD)
Patients in the LEAP-AHEAD Program arm will be shown a 40-minute interactional DVD and given the Healthy Habits Health Risk Appraisal, at baseline and 20 weeks that asks questions about diabetes self care practices and other health behaviors and gives recommendations in those areas. A score sheet based on the participant's responses will be left with the participant. At intervals from 0 to 44 weeks, patients will receive emailed informational pamphlets on diabetes and its complications, along with live telephone calls to answer any questions and check-in.
BEHAVIORALComputer Automated Self-Management (CASM)
CASM is a live and computer-assisted, low intensity, automated web and telephony based program that is directed at enhancing and sustaining diabetes self-management behavior over time. It provides education on the importance of healthy eating, physical activity and medication taking, and then asks patients to select an area for behavior change. At baseline patients will have a 45 minutes home visit to help them set goals and familiarize them with the website. A booster session is given at 20 weeks. Patients receive 8 ive phone calls over 12 months to support behavior change efforts.
BEHAVIORALComputer Automated Self-Management and Problem Solving Therapy (CAPS)
Patients in the CAPS program receive all of the protocol included in the CASM program, and in addition receive a Problem Solving program. Problem solving is a process by which an individual attempts an adaptive solution to stressful, real life problem(s). At baseline there is a 45 minute home visit where the Counselor will introduce the patient to CASM and will go on to teach the patient about diabetes distress and PST. They will then generate a list of distress-related problems to teach the steps of PST. The steps of PST are: problem definition, goal setting, brain storming, decision making, action planning, and solution review. At 20 weeks there will be a booster session. Patients receive 8 live phone calls over 12 months to support behavior change efforts.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Baseline, 16 weeks, and 12 months |
| 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. | Baseline, 16 weeks, and 12 months |
| Physical Activity. The CHAMPS (28 items) will be used to measure physical activity. | Baseline, 16 weeks, and 12 months |
| Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use. | Baseline, 16 weeks, and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| HbA1C | Baseline, 16 weeks, and 12 months |
| Blood Pressure | Baseline, 16 weeks, and 12 months |
| Fasting glucose | Baseline, 16 weeks, and 12 months |
| Lipids | Baseline, 16 weeks, and 12 months |
Countries
United States
Outcome results
None listed