Linking Self-Management and Primary Care for Diabetes 2 (LB2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Kaiser Permanente.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
InterVision
Oregon Research Institute
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00987285
First received: September 29, 2009
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

This project is primarily a behavioral study. We employed a three-arm, patient-randomized practical effectiveness trial to evaluate the impact of two different interactive, multimedia self-management programs, relative to "enhanced" usual care. The two interventions will be (a) the revised program from our present study, based on our social-ecological theory and the 5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs will be compared to a realistic "enhanced usual care" (UC) condition that will provide health risk appraisal feedback, control for computer interactions, and provide standardized advice on behavior change, but not the hypothesized key intervention processes of goal-setting, barriers identification, problem-solving, or social-environmental support. Patients will be randomized to conditions within clinic and will participate for 1 year.

The proposed project will test the effectiveness of a practical, automated-based intervention for primary care patients to facilitate dietary and physical activity practices, and medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity, medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and maintenance of the intervention programs (Specific Aim #3), and also factors related to program implementation, linkage to primary care, and program success with emphasis on cost, cost-effectiveness, and mediators and moderators of outcomes such as social-environment support (Aim #4).

Primary hypotheses:

  1. That the Automated Intervention received by Automated self-management (ASM) condition and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the primary outcomes.
  2. That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.

Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: CASM +
Behavioral: CASM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Linking Self-Management and Primary Care for Diabetes

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status). [ Time Frame: Baseline, 4 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes-specific quality of life (Diabetes Distress Scale), patient activation (PAM scale), and perceived social-environmental support (the Chronic Illness Resources Survey) at 4- and 12-month follow-ups. [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 463
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer Assisted Self Management plus Social Support
an interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media combined with enhanced support in the form of group Diabetes Care Management visits and live follow up phone calls from Diabetes Care Managers
Behavioral: CASM +
Computer Assisted Self Management plus Social Support
No Intervention: Usual care
will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support.
Experimental: Computer Assisted Self Management
An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media.
Behavioral: CASM
Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria:
  • being 25-75 years of age,
  • live independently,
  • have a telephone,
  • are able to read in either English or Spanish,
  • able to access the Internet at least twice per week
  • are capable of providing informed consent,
  • have been diagnosed with type 2 diabetes for at least 1 year
  • are overweight (BMI ≥ 25), and
  • have at least one additional UKPDS equation risk factor (i.e., high lipids, hypertension, HbA1c, or smoking)

Exclusion Criteria:

  • Exclusion criteria:
  • Suffering dementia or active psychosis,
  • Being on end-stage dialysis,
  • or predicted to live fewer than 2 years
  • Being institutionalized.
  • Pregnant women - women with gestational diabetes will not be enrolled, because there needs are quite different, but we won't specifically exclude women who are pregnant AND otherwise eligible, since we do acknowledge that it's possible that someone may be unaware that they are pregnant at the time of enrollment, or may become pregnant during the study, and that this will not affect their continued participation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00987285

Locations
United States, Colorado
Kaiser Permanente of Colorado
Denver, Colorado, United States, 80237-8066
Sponsors and Collaborators
Kaiser Permanente
InterVision
Oregon Research Institute
Investigators
Principal Investigator: Russell E Glasgow, PhD Kaiser Permanente
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00987285     History of Changes
Other Study ID Numbers: 2 R01 DK035524-21, R01DK035524, 2 R01 DK035524-21
Study First Received: September 29, 2009
Last Updated: April 26, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
RE AIM model
Type 2 Diabetes Mellitus
Interactive voice recognition
Computer Assisted Self Management

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

ClinicalTrials.gov processed this record on July 24, 2014