Internet Chronic Disease Self-Management Program for Australia

Chronic Disease Clinical Trial

Official title:

Evaluation of an Internet Chronic Disease Self-Management Program for Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787956
• Other study ID #: SU-10032008-1315
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2008
• Last updated: April 9, 2013
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• Internet Chronic Disease Self-Management Program (ICDSMP)

Locations

Country	Name	City	State
Australia	Country Health SA	Mt. Gambier	South Australia
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Status		6 an 12 months	No
Secondary	Health behaviors		6 and 2 months	No
Secondary	Health care utilization		6 and 12 months	No