NCT05493137

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 4, 2022

Last Update Submit

August 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • GPAQ

    Activity questionnaire for parents

    Reviews the past 7 days activities.

Secondary Outcomes (4)

  • CPAQ

    Reviews the past 7 days activities.

  • YPAQ

    Reviews the past 7 days activities.

  • Ineb adherence

    1 year

  • Lung function

    Best score in the last 1 year.

Interventions

No intervention will be provided, this is an observational study

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Parents of children with cystic fibrosis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 9, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.