ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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 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]

Not applicable

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cystic Fibrosis (CF)

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Human Genetics and Inherited Disorders

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]

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]

Improvement in Self-efficacy assessed using the Stanford Self-efficacy scale, assessed at baseline, 6 months and 12 months.

Timepoint [1]

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]

Improvement in lung function - spirometry; FORCED EXPIRATORY VOLUME IN ONE SECOND = FEV1, forced vital capacity FVC and FEF25-75.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Commonwealth government; Pathways Home Project

Address [1]

Department of Health and Ageing
Canberra GPO Box 9848
Australian Capital Territory 2601
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Hobart Hospital Statewide Ethics Committee

Ethics committee address [1]

Royal Hobart Hospital
Liverpool Street
Hobart 7001
Tasmania

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr David Reid

Address

The Dept of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside 4032
Queensland
Brisbane

Country

Australia

Phone

+61 7 3139 4000

Fax

David_Reid@health.qld.gov.au

Contact person for scientific queries

Name

Dr David Reid

Address

The Dept of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside 4032
Queensland
Brisbane

Country

Australia

Phone

+61 7 3139 4000

Fax

David_Reid@health.qld.gov.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically