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Internet Chronic Disease Self-Management Program for Australia

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: NCT00787956
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Kate Lorig, Stanford University

Tracking Information
First Submitted Date  ICMJE November 6, 2008
First Posted Date  ICMJE November 10, 2008
Last Update Posted Date April 10, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
Health Status [ Time Frame: 6 an 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
self-management behavior
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
  • Health behaviors [ Time Frame: 6 and 2 months ]
  • Health care utilization [ Time Frame: 6 and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
increasing self-efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Chronic Disease Self-Management Program for Australia
Official Title  ICMJE Evaluation of an Internet Chronic Disease Self-Management Program for Australia
Brief Summary The Internet Chronic Disease Self-Management Program (ICDSMP) is a pilot study of our existing, previous approved, Chronic Disease Self-Management Program Online. The online programme will be offered to 300 people with chronic disease in South Australia and evaluated for effectiveness, as well as satisfaction of both the South Australian peer facilitators and the participants with chronic disease. All participants will be recruited by the State of South Australia, after which they will complete informed consent and a questionnaire on a secure website housed at Stanford. They will take a 6-week online self-management program in groups of 20-25, and they fill our additional online questionnaires at 6 month and one year.
Detailed Description

The study will determine if the ICDSMP can be effective in the diverse population of South Australia. We hope that this online workshop will provide South Australians easy access to the Chronic Disease Self-Management Workshop. If successful, this program or similar programs could be made broadly available. The workshop being offered on the internet will offer this program as an alternative mode of service delivery to support self-management education for chronic diseases and will become an integral part of high quality primary health care in the state.

  1. A potential subject will learn of the project through advertisement done by existing community CDSMP providers or by websites or online newsletter provided by State of South Australia. The announcements will direct them to the study website at Stanford, where they will read a description of the project and leave their names and email addresses if they are interested in participating.
  2. When enough people are on the wait list to fill an online workshop, Stanford will send an email with a unique URL for each potential participant to log on, complete the informed consent, and fill out the baseline questionnaire. They will create their own username and password during this process.
  3. Once 24 people have enrolled, they will be assigned to a workshop and receive an email detailing when the workshop starts and inviting them to log on to familiarize themselves with the online environment and meet their moderators and other classmates online.
  4. They will start the 6-week workshop with each session starting a week apart with new content. They are expected to log on 2-3 times per week, for a total time of about 2 hours. They may log on more often if they wish, and they are not required to log on at any specific time.
  5. The workshop consists of didactic/interactive web pages, 4 discussion boards, an internal anonymous message center, a section of personalized tools that are available only to the individual participant and Stanford staff, and a help section. Each workshop is facilitated by 2 trained peer moderators, supervised by Stanford staff.
  6. The moderators offer help to those who may be confused by the goal setting exercise, for example, to give feedback to participants' progress, and to remind people to log on if they have not. They monitor for safety.
  7. After the end of the 6-week workshop, participants will be able to log into the workshop to review the past 6-weeks' participation and print out any useful workshop materials for future reference
  8. 6 months after the end of the 6-week workshop, participants will complete a follow up questionnaire, and again at 1 year.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Disease
Intervention  ICMJE Behavioral: Internet Chronic Disease Self-Management Program (ICDSMP)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: November 7, 2008)
300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:- be 18 or older

  • live in South Australia
  • have at least one long term condition (It is suitable for people with heart disease, lung disease, or type 2 diabetes as well as other diagnosed chronic condition)
  • and be able to fill out the on-line questionnaire without assistance.
  • Have access to the internet and an email account
  • Able to read English Exclusion Criteria:be pregnant
  • if they self-identify they are enrolled in another program similar to this one, they will be excluded from the study
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 Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00787956
Other Study ID Numbers  ICMJE SU-10032008-1315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kate Lorig, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kate R Lorig Stanford University
PRS Account Stanford University
Verification Date April 2013

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