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Internet Diabetes Self-Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372463
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
Robert Wood Johnson Foundation

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 7, 2006
Last Update Posted Date July 27, 2011
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Health related-quality of life
  • Metabolic control (HbA1c)
  • Heath care utilization
  • Behaviors
  • Self-efficacy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Diabetes Self-Management
Official Title  ICMJE Internet Diabetes Self-Management: A Randomized Trial
Brief Summary

Diabetes is a growing health problem causing personal suffering, comorbid conditions, premature death, and high costs to the individual, the health care system and society. Many of these problems can be prevented or delayed by controlling the disease. This in turn requires daily self-management by patients.

We will evaluate an Internet based small group Diabetes Self-Management Program. This program will be adapted from the Chronic Disease Self-Management Program Online, already developed and currently being evaluated by the investigators. Participants with type 2 diabetes will be randomized to participate in the Internet Program or serve as controls continuing with usual care. Treatment subjects will participate in a structured 6 week interactive web-based online class with 20-24 other participants and 2 trained peer moderators.

If successful, this project will result in a new and effective means of reaching the CDC objective and more importantly in improving the quality of life and health status of people with diabetes while reducing health care utilization and thus costs.

Detailed Description

Diabetes is a growing health problem causing personal suffering, comorbid conditions, premature death, and high costs to the individual, the health care system and society. Many of these problems can be prevented or delayed by controlling the disease. This in turn requires daily self-management by patients.

The CDC has recognized the importance of self-management by setting a 2010 objective of having 60% of diabetics receive diabetes education. Unfortunately, many people cannot receive such education because it is not available or they do not wish to or cannot participate in small group or one on one education.

The Internet may offer a viable alternative. We will evaluate an Internet based small group Diabetes Self-Management Program. This program will be adapted from the Chronic Disease Self-Management Program Online, already developed and currently being evaluated by the investigators. Participants with type 2 diabetes will be randomized to participate in the Internet Program or serve as controls continuing with usual care. Treatment subjects will participate in a structured 6 week interactive web-based online class with 20-24 other participants and 2 trained peer moderators.

Data will be collected online at baseline, 6 months and 1 year. Outcome measures include health related quality of life (fatigue, physical discomfort, the symptoms of hypoglycemia and hyperglycemia, activity limitations, health distress, and self-rated health), metabolic control (hemoglobin A1c), health care utilization (decreases in outpatient visits to physicians, increases in the percentage of participants having received an eye examination in the past year, increases in the number of times a health professional has examined participants' feet, and decreases in emergency department visits, hospitalizations, and hospital days), health behaviors (aerobic exercise, communication with physicians, diet, glucose self-monitoring, and self-examination of the feet), and self-efficacy to manage diabetes.

If successful, this project will result in a new and effective means of reaching the CDC objective and more importantly in improving the quality of life and health status of people with diabetes while reducing health care utilization and thus costs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Behavioral: 6-week Online Diabetes Self-Management Educational Program
Study Arms  ICMJE Not Provided
Publications * Case S, Jernigan V, Gardner A, Ritter P, Heaney CA, Lorig KR. Content and frequency of writing on diabetes bulletin boards: does race make a difference? J Med Internet Res. 2009 Jun 24;11(2):e22. doi: 10.2196/jmir.1153.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 2, 2007)
700
Original Enrollment  ICMJE
 (submitted: September 6, 2006)
500
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes
  • Live in the United States
  • Access to internet and an email account

Exclusion Criteria:

  • Under 18 years of age
  • Pregnant
  • Treatment for cancer in past 12 months
  • Have taken any Stanford self-management program previously
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372463
Other Study ID Numbers  ICMJE 49148
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Robert Wood Johnson Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kate Lorig, DrPH Stanford University
Study Director: Diana Laurent, MPH Stanford University
PRS Account Robert Wood Johnson Foundation
Verification Date July 2011

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