Cystic Fibrosis in ChildrenPHACTS-CFNCT05493137
Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF)
An observational study of Cystic Fibrosis in Children, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Cystic Fibrosis in Children
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Parents of children with cystic fibrosis.
Who may be able to join
- Parents of Children aged 5-16 years.
- Under the care of Cambridge University Hospitals CF team
- Confirmed Cystic Fibrosis diagnosis
- Uses an ineb as main nebulizer delivery device.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).
- If not yet doing lung function.
- If has any other self-identified physical disability which may limit physical activity.
Trial locations and contacts
No sites are listed yet.
Colin Hamilton, MRes contact
About this study
Official title: Investigating Physical Activity Levels of Parents of Children With Cystic Fibrosis and Its Influence on Their Children's Physical Activity Levels and Nebuliser Use
This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- No intervention will be provided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be providedOther
No intervention will be provided, this is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
GPAQ
Activity questionnaire for parents
Measured: Reviews the past 7 days activities.
Secondary outcomes (4)
CPAQ
Physical activity Questionnaire for children aged 5-11 (From medical notes)
Measured: Reviews the past 7 days activities.
YPAQ
Physical activity Questionnaire for children aged 12 and over (From medical notes)
Measured: Reviews the past 7 days activities.
Ineb adherence
Adherence to recommended number of nebulised treatment from the i-adhere software downloaded from the ineb device.
Measured: 1 year
Lung function
FEV1 (z-score and %), FVC (z-score and %), FEF2575 (z-score and %) (From medical notes)
Measured: Best score in the last 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kieren Lock, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493137
- Sponsor's protocol ID
- A096376
- Acronym
- PHACTS-CF
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Physical Activity Levels of Parents of Children With Cystic Fibrosis and Its Influence on Their Children's Physical Activity Levels and Nebuliser Use
- ClinicalTrials.gov ID
- NCT05493137
- Acronym / sponsor ID
- PHACTS-CF / A096376
- Conditions
- Cystic Fibrosis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of children with cystic fibrosis.
Key inclusion criteria (5 listed)
- Parents of Children aged 5-16 years.
- Under the care of Cambridge University Hospitals CF team
- Confirmed Cystic Fibrosis diagnosis
- Uses an ineb as main nebulizer delivery device.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Key exclusion criteria (3 listed)
- Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).
- If not yet doing lung function.
- If has any other self-identified physical disability which may limit physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be providedNo intervention will be provided, this is an observational study | Other | – |
Primary outcome
GPAQ
Time frame: Reviews the past 7 days activities.
Activity questionnaire for parents
4 secondary outcomes
CPAQ
Time frame: Reviews the past 7 days activities.
YPAQ
Time frame: Reviews the past 7 days activities.
Ineb adherence
Time frame: 1 year
Lung function
Time frame: Best score in the last 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Hamilton, MRes contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis in Children, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kieren Lock, Bsc (01223256726, kieren.lock@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GPAQ (time frame: Reviews the past 7 days activities.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.