Physical Activity Levels of Parents of Children With Cyst... | NCT05493137

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

NCT05493137

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Status

Unknown status

Last Update Posted

Aug 9, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cystic Fibrosis in Children

Interventions

No intervention will be provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Estimated

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Aug 4, 2022

First Submission Date that Met QC Criteria

Aug 5, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2022

Last Update Posted Date

Aug 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kieren Lock, Principal Investigator, Cambridge University Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Cambridge University Hospitals NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention will be provided	Other	No intervention will be provided, this is an observational study

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Parents of children with cystic fibrosis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kieren Lock, Bsc	Contact	01223256726		kieren.lock@addenbrookes.nhs.uk
Colin Hamilton, MRes	Contact			colin.hamilton@addenbrookes.nhs.uk

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided