Trial Review

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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 information initially provided
8/04/2021
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] 292262 0
None
Universal Trial Number (UTN)
Trial acronym
Action: PACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 303783 0
Condition category
Condition code
Respiratory 303151 303151 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 303321 303321 0 0
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] 298438 0
Treatment: Other
Intervention code [2] 298439 0
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] 302551 0
Change in physical activity participation objectively measured via accelerometry
Timepoint [1] 302551 0
Baseline
At the end of the intervention phase
Secondary outcome [1] 336356 0
Change in exercise capacity as measured by the Modified Shuttle Test (MST)
Timepoint [1] 336356 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [2] 336358 0
Change in lung function as measured by Forced Expiratory Volume in one second (FEV1)
Timepoint [2] 336358 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [3] 336359 0
Change in health related quality of life as assessed by the Cystic Fibrosis Questionnaire (CFQ-R)
Timepoint [3] 336359 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [4] 336360 0
Change in Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 336360 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [5] 336361 0
Change in the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [5] 336361 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [6] 336364 0
Time to first hospital admission, by medical record review
Timepoint [6] 336364 0
12 months post end of intervention
Secondary outcome [7] 336426 0
Change in the Centre for Epidemiological Studies - Depression (CES-D) scale
Timepoint [7] 336426 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [8] 336433 0
Change in physical activity participation self reported by the Habitual Activity Estimation Scale (HAES)
Timepoint [8] 336433 0
Baseline
At the end of the intervention phase
3 months post intervention
Secondary outcome [9] 336556 0
Change in reasons for participating in physical activity (BREQ-2)
Timepoint [9] 336556 0
Baseline
3 months post intervention
Secondary outcome [10] 336797 0
Number of hospital inpatient days by medical record review
Timepoint [10] 336797 0
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?
No
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
75
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 8448 0
The Alfred - Prahran
Recruitment hospital [2] 8449 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 8450 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 8451 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 14457 0
Westmead Hospital - Westmead
Recruitment hospital [6] 14458 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 14459 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [8] 14460 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 27474 0
2050 - Camperdown
Recruitment postcode(s) [2] 27472 0
2145 - Westmead
Recruitment postcode(s) [3] 27473 0
2145 - Westmead
Recruitment postcode(s) [4] 16521 0
3004 - Prahran
Recruitment postcode(s) [5] 16522 0
3052 - Parkville
Recruitment postcode(s) [6] 16523 0
3168 - Clayton
Recruitment postcode(s) [7] 27475 0
5000 - Adelaide
Recruitment postcode(s) [8] 16524 0
7000 - Hobart
Recruitment outside Australia
Country [1] 9022 0
United Kingdom
State/province [1] 9022 0

Funding & Sponsors
Funding source category [1] 296808 0
Charities/Societies/Foundations
Name [1] 296808 0
United Kingdom CF Trust
Country [1] 296808 0
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] 295825 0
None
Name [1] 295825 0
Address [1] 295825 0
Country [1] 295825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298042 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 298042 0
Office of Ethics and Research Governance
Old Baker Building, Level 1
The Alfred
55 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 298042 0
Australia
Date submitted for ethics approval [1] 298042 0
25/01/2017
Approval date [1] 298042 0
03/02/2017
Ethics approval number [1] 298042 0
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 75794 0
Prof Anne Holland
Address 75794 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 75794 0
Australia
Phone 75794 0
+61 3 9903 0214
Fax 75794 0
+61 3 9903 0556
Email 75794 0
anne.holland@monash.edu
Contact person for public queries
Name 75795 0
Dr Narelle Cox
Address 75795 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 75795 0
Australia
Phone 75795 0
+61 0409227157
Fax 75795 0
+61 3 9903 0556
Email 75795 0
narelle.cox@monash.edu
Contact person for scientific queries
Name 75796 0
Prof Anne Holland
Address 75796 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 75796 0
Australia
Phone 75796 0
+61 3 9903 0214
Fax 75796 0
+61 3 9903 0556
Email 75796 0
anne.holland@monash.edu

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 (a.holland@latrobe.edu.au) 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Cox NS, Eldridge B, Rawlings S On behalf of Youth ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWeb-based physical activity promotion in young people with CF: a randomised controlled trial.2022https://dx.doi.org/10.1136/thorax-2022-218702
EmbaseA web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: Protocol for a randomized controlled trial.2019https://dx.doi.org/10.1186/s12890-019-0942-3
EmbaseCurrent perspectives of physical activity in cystic fibrosis.2019https://dx.doi.org/10.1080/17476348.2019.1552833
N.B. These documents automatically identified may not have been verified by the study sponsor.