Reducing Distress and Improving Self-Care in Diabetes (REDEEM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00714441
First received: July 9, 2008
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Diabetes Type 2
Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD)
Behavioral: Computer Automated Self-Management (CASM)
Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Distress and Improving Self-Care in Diabetes

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • Physical Activity. The CHAMPS (28 items) will be used to measure physical activity. [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use. [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1C [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: Baseline, 16 weeks, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 392
Study Start Date: July 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Computer Automated Self-Management (CASM). Please see description below for CASM.
Behavioral: Computer 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.
Active Comparator: 3
Computer Automated Self-Management and Problem Solving Therapy (CAPS). Please see descriptions below for CAPS (also refer to CASM with is included in the CAPS program).
Behavioral: Computer 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.
Behavioral: Computer 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.
Active Comparator: 1
Lifestyle and Activities Education Program (LEAP-AHEAD). Please see description below for LEAP-AHEAD.
Behavioral: Lifestyle 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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714441

Locations
United States, California
UC San Francisco, Family and Community Medicine Dept.
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Lawrence Fisher, Ph.D. University of California, San Francisco
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00714441     History of Changes
Other Study ID Numbers: 2R01DK061937-05A1, 2R01DK061937-05A1
Study First Received: July 9, 2008
Last Updated: April 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Diabetes Type 2
Distress
Problem Solving Therapy
Computer Automated Self-Management (CASM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014