ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001009303

Ethics application status

Approved

Date submitted

6/07/2017

Date registered

13/07/2017

Date last updated

2/03/2023

Date data sharing statement initially provided

6/08/2019

Date results provided

2/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Action: PACT. Be Active. Online. A trial to promote physical activity in young people with cystic fibrosis.

Scientific title

A randomised controlled trial of a novel web-based intervention to promote physical activity participation in young people with cystic fibrosis.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Action: PACT

Linked study record

Health condition

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

Cystic Fibrosis

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

The aim of this project is to determine whether the use of an online program (ActivOnline – www.activonline.com.au) is more effective than usual care at improving physical activity participation in young people with Cystic Fibrosis (CF) after an inpatient admission to hospital. People who agree to take part in the study will be randomly allocated to one of two groups. The intervention group will use the ActivOnline program, via the internet, as well as receive usual care. Usual care will comprise provision of details for an online information source regarding physical activity participation and physical activity targets for children and young adults (http://www.nhs.uk/Livewell/fitness/Pages/physical-activity-guidelines-for-young-people.aspx) as well as activity and exercise guidance, as indicated, as part of their routine clinical care on hospital discharge. ActivOnline was developed in accordance of the principles of motivational interviewing and has been used to promote physical activity participation in older adults with chronic respiratory disease. Those allocated to the ActivOnline group will be provided with a unique logon and password to access the ActivOnline program and will be asked to record their daily physical activity and exercise using the secure portal. When logging onto ActivOnline they will be prompted to set goals, will record their PA or exercise using a pedometer or other device of their choice and will regularly enter data about that will be displayed graphically so they can see their progress.. The messaging tab on the Home screen is there for communication between researchers and participants. For example participants will be able to send to questions at any time and clinicians will be able to remind participants to review their goals each week. The intervention phase will last for 12 weeks during which time participants will have access to the ActivOnline program to facilitate their participation in exercise and seek support in reaching their activity goal.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Participants randomised to the usual care group will be provided with details for an online information source regarding physical activity participation and physical activity targets for children and young adults (http://www.nhs.uk/Livewell/fitness/Pages/physical-activity-guidelines-for-young-people.aspx). These guidelines are consistent with Australian Department of Health recommendations for daily physical activity participation. Participants in the control group will receive activity and exercise guidance, as indicated, as part of their routine clinical care on hospital discharge.

Control group

Active

Outcomes

Primary outcome [1]

Change in physical activity participation objectively measured via accelerometry

Timepoint [1]

Baseline
At the end of the intervention phase

Secondary outcome [1]

Change in exercise capacity as measured by the Modified Shuttle Test (MST)

Timepoint [1]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [2]

Change in lung function as measured by Forced Expiratory Volume in one second (FEV1)

Timepoint [2]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [3]

Change in health related quality of life as assessed by the Cystic Fibrosis Questionnaire (CFQ-R)

Timepoint [3]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [4]

Change in Hospital Anxiety and Depression Scale (HADS)

Timepoint [4]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [5]

Change in the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [5]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [6]

Time to first hospital admission, by medical record review

Timepoint [6]

12 months post end of intervention

Secondary outcome [7]

Change in the Centre for Epidemiological Studies - Depression (CES-D) scale

Timepoint [7]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [8]

Change in physical activity participation self reported by the Habitual Activity Estimation Scale (HAES)

Timepoint [8]

Baseline
At the end of the intervention phase
3 months post intervention

Secondary outcome [9]

Change in reasons for participating in physical activity (BREQ-2)

Timepoint [9]

Baseline
3 months post intervention

Secondary outcome [10]

Number of hospital inpatient days by medical record review

Timepoint [10]

12 months post end of intervention

Eligibility

Key inclusion criteria

Confirmed diagnosis of cystic fibrosis
Hospital inpatient admission (including hospital in the home) for intravenous antibiotic therapy for a respiratory cause
Able to provide informed consent
Able to access the internet via computer or mobile device

Minimum age

12 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of severe co-morbidity limiting mobilisation or physical activity participation
Previous lung transplantation
Pregnancy

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated, block randomisation with stratification for:
1) site
2) whether or not the participant is enrolled in fulltime schooling (primary or secondary)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Not applicable

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A mixed model within (time) and between (group) ANOVA will be conducted to investigate change across all outcome measures. Linear regression modelling will be used to investigate impact of demographic and baseline measures on the change in physical activity (PA). Sample size was based on physical activity PA participation measured post hospitalisation in our population of young adults with CF. A difference of 20 mins/day between groups in PA would correspond to achievement of accepted activity targets (> or = 150 mins/week). This assumes a standard deviation of 26 mins/week with a power of 80% and a significance level of p<0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/09/2017

Actual

27/09/2017

Date of last participant enrolment

Anticipated

1/02/2020

Actual

7/02/2020

Date of last data collection

Anticipated

1/05/2021

Actual

6/05/2021

Sample size

Target

Accrual to date

Final

107

Recruitment in Australia

Recruitment state(s)

NSW,SA,TAS,VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment hospital [2]

The Royal Childrens Hospital - Parkville

Recruitment hospital [3]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [4]

Royal Hobart Hospital - Hobart

Recruitment hospital [5]

Westmead Hospital - Westmead

Recruitment hospital [6]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [7]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [8]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment postcode(s) [3]

3168 - Clayton

Recruitment postcode(s) [4]

7000 - Hobart

Recruitment postcode(s) [5]

2145 - Westmead

Recruitment postcode(s) [6]

2145 - Westmead

Recruitment postcode(s) [7]

2050 - Camperdown

Recruitment postcode(s) [8]

5000 - Adelaide

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

United Kingdom CF Trust

Address [1]

2nd Floor
One Aldgate
London EC3N 1RE

Country [1]

United Kingdom

Primary sponsor type

University

Name

Monash University

Address

Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

Office of Ethics and Research Governance
Old Baker Building, Level 1
The Alfred
55 Commercial Road
Melbourne 
Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2017

Approval date [1]

03/02/2017

Ethics approval number [1]

HREC/16/Alfred/188(Alfred 7/17)

Summary

Brief summary

Cystic Fibrosis (CF) is a complex, progressive, life-limiting disease that predominantly affects children and young adults. ‘Flare-ups’ of CF lung disease are common in people with this condition and often lead to admission to hospital and decline in lung capacity, imposing considerable burden on patients, their families and the healthcare system.  
Physical activity (PA) participation is a low-cost, easily accessible treatment option that has the potential to reduce the impact and progression of chronic lung disease in CF and may help reduce ‘flare ups’ of lung disease. However uptake and adherence to PA and exercise rehabilitation programs by young people with CF is poor. 
Advances in Internet technology and accessibility have made it possible for people to receive specialist medical care and rehabilitation therapy without attending the hospital. By using a secure website, readily accessible on any smartphone, tablet, laptop or computer it is possible for young people with CF to track their PA participation and receive feedback – at any time and place of their choosing. 
The aim of this project is to determine whether use of an online program to track PA participation and provide feedback, is more effective than usual care at improving PA participation, exercise capacity and quality of life, and prolonging the time to next hospital admission. People who agree to take part in the study will be randomly allocated to use the online program via the Internet, or to usual post-hospital care. 
At the beginning and end of the 12 weeks of the intervention phase, and at 3-months post completion of the intervention period, all participants will undergo measurements of PA participation, exercise capacity and health status. At 12 months- post completion of the intervention, hospital medical records will be reviewed to determine the frequency of hospital admission and number of hospital days. 
It is hypothesized that:
1.	The web-based intervention will improve uptake and participation in PA by young people with CF.
2.	The web-based intervention to increase PA will lead to improvements in exercise capacity, lung function, quality of life, anxiety and depression and sleep quality in young people with CF and reduced health care utilisation for this group in the 12 months post intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Anne Holland

Address

Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 3 9903 0214

Fax

+61 3 9903 0556

[email protected]

Contact person for public queries

Name

Narelle Cox

Address

Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 0409227157

Fax

+61 3 9903 0556

[email protected]

Contact person for scientific queries

Name

Anne Holland

Address

Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 3 9903 0214

Fax

+61 3 9903 0556

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data of published results only can be shared once approval has been obtained from the relevant Human Research Ethics Committee.

When will data be available (start and end dates)?

Data will not be available prior to publication of the main trial results. There is no specific end date until which data will be available.

Available to whom?

Data will be available on a case by case basis, at the discretion of the Coordinating Principal Investigator and after protocol review and approval of the relevant Human Research Ethics Committees.

Available for what types of analyses?

Data will be available for analyses that are approved by the relevant Human Research Ethics Committees.

How or where can data be obtained?

Access to data will be subject to approval by the Coordinating Principal Investigator (email request to ([email protected]) and approval by the Alfred Health Human Research Ethics Committee. Individuals requesting data will also need to apply to the Alfred Health HREC specifying their intended use of the data.
Data will only be released once all relevant approvals have been obtained.

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

Source	Title	Year of Publication	DOI
Embase	A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: Protocol for a randomized controlled trial.	2019	https://dx.doi.org/10.1186/s12890-019-0942-3
Embase	Current perspectives of physical activity in cystic fibrosis.	2019	https://dx.doi.org/10.1080/17476348.2019.1552833
Embase	Web-based physical activity promotion in young people with CF: a randomised controlled trial.	2022	https://dx.doi.org/10.1136/thorax-2022-218702

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically