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Completed

NCT Number: NCT00987285

Linking Self-Management and Primary Care for Diabetes 2

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente of Colorado

Denver, Colorado, 80237-8066, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CASM +

Behavioral

Computer Assisted Self Management plus Social Support

CASM

Behavioral

Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • InterVision
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Oregon Research Institute

Registry information

Official study title

Linking Self-Management and Primary Care for Diabetes

Acronym: LB2

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Sep 30, 2009
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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