Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF) (PHACTS-CF)

August 5, 2022 updated by: Kieren Lock, Cambridge University Hospitals NHS Foundation Trust

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents of children with cystic fibrosis.

Description

Inclusion Criteria:

  1. Parents of Children aged 5-16 years.
  2. Under the care of Cambridge University Hospitals CF team
  3. Confirmed Cystic Fibrosis diagnosis
  4. Uses an ineb as main nebulizer delivery device.
  5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  1. Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).
  2. If not yet doing lung function.
  3. If has any other self-identified physical disability which may limit physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPAQ
Time Frame: Reviews the past 7 days activities.
Activity questionnaire for parents
Reviews the past 7 days activities.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAQ
Time Frame: Reviews the past 7 days activities.
Physical activity Questionnaire for children aged 5-11 (From medical notes)
Reviews the past 7 days activities.
YPAQ
Time Frame: Reviews the past 7 days activities.
Physical activity Questionnaire for children aged 12 and over (From medical notes)
Reviews the past 7 days activities.
Ineb adherence
Time Frame: 1 year
Adherence to recommended number of nebulised treatment from the i-adhere software downloaded from the ineb device.
1 year
Lung function
Time Frame: Best score in the last 1 year.
FEV1 (z-score and %), FVC (z-score and %), FEF2575 (z-score and %) (From medical notes)
Best score in the last 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A096376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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