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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 257719 0
Department of Health and Ageing
Canberra GPO Box 9848
Australian Capital Territory 2601
Australia
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
Royal Hobart Hospital
Liverpool Street
Hobart 7001
Tasmania
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
Cystic fibrosis (CF) is a progressive, multi-system genetic disorder that increases in complexity and severity with age. A substantial increase in survival has occurred over the past 50 years and where previously affected individuals died predominantly in childhood, this is now a rare event. CF population projections predict that the majority of children now living with CF will survive into their fifth decade.
The challenge facing adult healthcare providers is how to consolidate the gains made during paediatric care and to assist adult CF patients to manage a condition made increasingly complex by the onset of CF-related diabetes, progressive lung and liver disease, and osteoporosis in the context of trying to lead an independent life.

Equipping individuals affected by chronic disease with skills to self-manage has been shown to improve both health-related outcomes and quality of life, but there has been little work in CF in this area.

The aim of this pilot study is to assess the feasibility of a mentor-based behavioural modification intervention to enhance self-efficacy to self-manage, with some individuals utilizing an information and communication technology (IT) tool - a modified mobile phone - that enabled self-recording of symptoms with immediate visual feedback on reported symptoms.
Trial website
Trial related presentations / publications
Conference Presentations
Jessup M, Cameron-Tucker H, Cummings E, Hauser J, Joseph L, Saddington H, Cheney J, Turner P, Wainwright C, Reid DW. Someone to talk to: Adolescent and adult feedback on their experience of mentoring and IT. Oral presentation, Australian and New Zealand Cystic Fibrosis Nurses Conference, Perth, 2010.

Cameron-Tucker HL, Joseph L, *Cummings E, Cystic Fibrosis Research Team led by *Reid D. Outcomes of Health-Mentor Training to improve Self- Management by People with Cystic Fibrosis (CF). TSANZ ASM 2009, poster TP105. Respirology, 2009; 14 (s1):A58.

M Jessup, Cystic Fibrosis Research Team led by DW Reid. Pathways Home Project: A pilot study of chronic disease self-management in cystic fibrosis. Asia Pacific Society of Respirology. Conference 2007 Gold Coast Oral Poster 1-052.

H Cameron-Tucker, Cystic Fibrosis Research Team led by DW Reid. Telephone-mentor training of Health professionals to facilitate self-management for people with cystic fibrosis. Asia Pacific Society of Respirology Conference, 2007 Gold Coast Oral Poster 1-053.

Turner, P., Cummings, E., Busch, J., Reid, DW., Fitzpatrick, P., Cameron-Tucker, H., Joseph, L., Walters, EH., Jessup, M. Pathways Home Project: The Development of an IT Support Tool to Aid Chronic Disease Self Management In Cystic Fibrosis (CF) 7th Australasian Cystic Fibrosis Conference, Sydney, August 11-14 2007.

Chau, S., Cummings, E. and Turner, P. Experiences and Insights from the Development of a Mobile Self Management System for Cystic Fibrosis Sufferers in Tasmania. MedInfo 2007, Brisbane, 2007, August 20-24.

Turner, P., Cummings, E., Busch, J., Reid, DW., Fitzpatrick, P., Cameron-Tucker, H., Joseph, L., Walters, EH., Jessup, M. Pathways Home Project: The Development of an it Support Tool to Aid Chronic Disease Self Management In Cystic Fibrosis (CF). PHCRED Symposium 2007.

Cummings, EA and Courtney-Pratt, HM and Reid, DW and Robinson, A and Turner, P and Walters, EH and Wood-Baker, R, ‘Issues and experiences with technology supported development of patient self-efficacy and self-managed of chronic disease’, Australasian Journal on Ageing, 25 (supp 1) pp. A14-15. ISSN 1440-6381 (2006).
Cummings, EA and Turner, P, ‘Pathways Home Project: Patient Self-management and Self-efficacy through the Deployment of ICTs’, eValues: Proceedings of the 19th Bled eConference, 5-7 June 2006, Bled Slovenia EJ ISBN 961-232-191-4 (2006)
Cummings, EA and Turner, P, ‘Pathways Home: developing & deploying technology to support patient empowerment in the self-management of chronic illness in the community’. Proceedings of CollECTeR Europe 2006, 9-10 June 2006, Basel, Switzerland, pp. 261-269.
Cummings, EA and Turner, P, ‘Patient Empowerment and Self-efficacy in Chronic Disease Management: Considerations for Information Systems Development, Deployment and Evaluation’, Paradigms Politics Paradoxes: Proceedings of the 29th Information Systems Research Seminar in Scandinavia, 12-15 August 2006, Scandinavia EJ (2006) [Refereed Conference]
Cummings, EA and Turner, P, ‘Pathways Home: Considerations for Technology Solutions aimed at Supporting Self-management of Chronic illness’, HIC 2005 & HINZ 2005, 31st July to 2nd August 2005, Melbourne Convention Centre, pp. 1-9. ISBN 0 9751013 5 8 (2005).
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
David_Reid@health.qld.gov.au
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
David_Reid@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary