Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 registered on ANZCTR


Registration number
ACTRN12611000802909
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
29/07/2011
Date last updated
29/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, controlled trial of behavioural modifications using an Information Technology (IT) tool to improve self-management in adolescents and adults with Cystic Fibrosis: A pilot study.
Scientific title
A randomised controlled trial of behavioural modification utilising an Information technology tool in adolescents and adults with Cystic fibrosis to improve Self-management skills
Secondary ID [1] 252767 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis (CF) 258268 0
Condition category
Condition code
Respiratory 258460 258460 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 259208 259208 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural interventions including goal setting, action planning and self-monitoring using an IT tool and facilitated by telephone mentoring. There are three treatment arms;
1. Mentor plus IT tool (modified mobile phone)
2. Mentor only
3. Control = usual CF care.

The active intervention lasted for six months followed by a six month washout. The IT tool consists of a mobile phone that has been modified to allow self-recording of symptoms. Entries were then sent to a central data server, converted into graphical format and send back to the participant immediately. This allowed them to viw their progress compared to baseline when well, which had been recorded at the study commencement. The participants were asked to use the moble phone on a daily basis.

The frequency of participant-mentor telephone interaction occurred initially on a weekly basis, initiated by the mentor with the intention of becoming increasingly negotiated by the participant as their self-efficacy developed.
Intervention code [1] 257283 0
Behaviour
Comparator / control treatment
Normal CF care delived by either the statewide (Tasmania) adult CF care team or paediatric CF care, which was delivered through three different hospitals based in the regional areas of north, northwest and south.
Control group
Active

Outcomes
Primary outcome [1] 259295 0
Improvement in Self-efficacy assessed using the Stanford Self-efficacy scale, assessed at baseline, 6 months and 12 months.
Timepoint [1] 259295 0
Baseline assessment were made and then active intervention outcomes were re-assessed at three months and six months of active intervention. There was a 12 month from recruitment follow-up visit when assessments were repeated to see if there was any evidence for deterioration (six months after cessation of active intervention)
Secondary outcome [1] 265722 0
Improvement in lung function - spirometry; FORCED EXPIRATORY VOLUME IN ONE SECOND = FEV1, forced vital capacity FVC and FEF25-75.
Timepoint [1] 265722 0
Baseline, three months and six months of active intervention and then a 12 month follow-up (six months after cessation of active intervention)

Eligibility
Key inclusion criteria
Diagnosis of Cystic Fibrosis and no exacerbation for one month.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An exacerbation within the past month and severe disease.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Initial invitation to participate letter sent out to all potential participants and those who responded in the affirmative were then contacted by phone by a study coordinator and baseline demographics and consent obtained. Randomisation was centrally generated by a computer program. The clinical team treating the patients was blinded to intervention, all of which were undertaken by a team of mentors removed from usual clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257719 0
Government body
Name [1] 257719 0
Commonwealth government; Pathways Home Project
Country [1] 257719 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aging.
Address
GPO Box 9848,
Canberra ACT 2601, Australia
Country
Australia
Secondary sponsor category [1] 256936 0
None
Name [1] 256936 0
Address [1] 256936 0
Country [1] 256936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259767 0
Royal Hobart Hospital Statewide Ethics Committee
Ethics committee address [1] 259767 0
Ethics committee country [1] 259767 0
Australia
Date submitted for ethics approval [1] 259767 0
Approval date [1] 259767 0
Ethics approval number [1] 259767 0
H0008939

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31703 0
Address 31703 0
Country 31703 0
Phone 31703 0
Fax 31703 0
Email 31703 0
Contact person for public queries
Name 14950 0
Dr David Reid
Address 14950 0
The Dept of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside 4032
Queensland
Brisbane
Country 14950 0
Australia
Phone 14950 0
+61 7 3139 4000
Fax 14950 0
Email 14950 0
[email protected]
Contact person for scientific queries
Name 5878 0
Dr David Reid
Address 5878 0
The Dept of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside 4032
Queensland
Brisbane
Country 5878 0
Australia
Phone 5878 0
+61 7 3139 4000
Fax 5878 0
Email 5878 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.