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

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ClinicalTrials.gov Identifier: NCT00987285
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : May 25, 2015
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
InterVision
Oregon Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

September 29, 2009
September 30, 2009
May 25, 2015
January 2007
December 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00987285 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Linking Self-Management and Primary Care for Diabetes 2
Linking Self-Management and Primary Care for Diabetes

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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Type 2 Diabetes Mellitus
  • Behavioral: CASM +
    Computer Assisted Self Management plus Social Support
  • Behavioral: CASM
    Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
  • 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
    Intervention: Behavioral: CASM +
  • 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.
    Intervention: Behavioral: CASM

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
463
Same as current
December 2014
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00987285
2R01DK035524-21( U.S. NIH Grant/Contract )
R01DK035524 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • InterVision
  • Oregon Research Institute
Principal Investigator: Russell E Glasgow, PhD Kaiser Permanente
Kaiser Permanente
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP