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

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: Cystic Fibrosis in Children
• Intervention / Treatment: Other: No intervention will be provided

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Kieren Lock, Bsc; Phone Number: 01223256726; Email: kieren.lock@addenbrookes.nhs.uk
• Study Contact Backup: Name: Colin Hamilton, MRes; Email: colin.hamilton@addenbrookes.nhs.uk

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAQ	Physical activity Questionnaire for children aged 5-11 (From medical notes)	Reviews the past 7 days activities.
YPAQ	Physical activity Questionnaire for children aged 12 and over (From medical notes)	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.	1 year
Lung function	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

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

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: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• 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