Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00787956




Registration number
NCT00787956
Ethics application status
Date submitted
6/11/2008
Date registered
10/11/2008
Date last updated
10/04/2013

Titles & IDs
Public title
Internet Chronic Disease Self-Management Program for Australia
Scientific title
Evaluation of an Internet Chronic Disease Self-Management Program for Australia
Secondary ID [1] 0 0
SU-10032008-1315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Health Status
Timepoint [1] 0 0
6 an 12 months
Secondary outcome [1] 0 0
Health behaviors
Timepoint [1] 0 0
6 and 2 months
Secondary outcome [2] 0 0
Health care utilization
Timepoint [2] 0 0
6 and 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Country Health SA - Mt. Gambier
Recruitment postcode(s) [1] 0 0
5290 - Mt. Gambier
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Other
Name
Stanford University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00787956
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate R Lorig
Address 0 0
Stanford University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00787956