Condition category
Infections and Infestations
Date applied
20/03/2019
Date assigned
25/03/2019
Last edited
25/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chickenpox is one of the commonest illnesses in childhood. For most children with mild disease it is unpleasant but other than a few scars they will have no long term consequences, however a small proportion will develop very severe potentially life threatening side effects.

Very effective vaccines exist against chickenpox and have been safely used in the rest of the world for over twenty years. However in the NHS new vaccines can only be introduced if they can be shown to be good value for money. The government body that assesses this, the Joint Committee for Vaccination and Immunisation (JCVI) examined the use of chickenpox vaccines in 2010 but advised against vaccine introduction. One of the main areas of uncertainty identified was the degree to which the quality of life of children and their parents is affected

Who can participate?
Children who have, have recently had, or have recently been exposed to chickenpox can take part in this study.

What does the study involve?
This study will collect more accurate data on the age distribution and impact on quality of life for children hospitalised by chickenpox and their families. To do this we will identify children with chickenpox in hospitals and the community and ask them and their parents to fill out short diary cards made up of standard quality of life survey tools . There will be no interventions, tests or hospital visits as part of the study – just completion of simple diaries.

What are the possible benefits and risks of participating?
None

Where is the study run from?
1. Bristol Children's Hospital, Bristol, UK
2. Hospital Pediátrico de Coimbra, Coimbra, Portugal

When is the study starting and how long is it expected to run for?
March 2018 to December 2020

Who is funding the study?
The National Institute for Health Research (UK)

Who is the main contact?
Dr. Robin Marlow, robin.marlow@bristol.ac.uk


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Trial website

Contact information

Type

Scientific

Primary contact

Dr Robin Marlow

ORCID ID

http://orcid.org/0000-0002-3192-3102

Contact details

Level 6
UHBristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
0117 3420172
robin.marlow@bristol.ac.uk

Type

Scientific

Additional contact

Prof Fernanda Rodrigues

ORCID ID

http://orcid.org/0000-0002-5820-5215

Contact details

Centro Hospitalar e Universitário de Coimbra - Hospital Pediátrico
Coimbra
3000-602
Portugal
+351 239 488 700
rodriguesfmp@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.3

Study information

Scientific title

Prospective cohort study of quality of life impact and healthcare usage in hospitalised and community cases of varicella zoster in children and their carers

Acronym

QoLPox

Study hypothesis

Whilst a ubiquitous disease of childhood with vaccines available to prevent it, chickenpox is not currently part of the UK or Portuguese childhood vaccine programme. Current evidence on the quality of life burden on children and their families is limited, we aim to follow a cohort of community and hospitalised cases of varicella to determine the QALY loss due to this disease.

Ethics approval

1. Hospital arm approved 09/04/2018, East of Scotland Research Ethics Service (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY; 01382 383848; eosres.tayside@nhs.net), ref: 18/ES/0040.
2. Community arm approved 22/01/2018, University of Bristol Faculty of Health Services Ethics (University of Bristol, Beacon House, Queens Road, Bristol, BS8 1QU, UK; 0117 928 9000; liam.mckervey@bristol.ac.uk), ref: 60721

Study design

International multi-centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format please use contact details to request a participant information sheet.

Condition

Chickenpox

Intervention

Inpatient arm:
We will recruit patients with with acute varicella or secondary complications requiring admission to hospital. After informed consent they (child and both carers) will be asked to complete daily quality of life diaries whilst an inpatient. After discharge they will complete weekly diaries for one month with final follow up diary at 6m.
Community arm:
We will recruit patients with acute varicella in the community. After informed consent they (child and both carers) will be asked to complete daily diaries (alternate day quality of life) for 7-14 days until recovered to baseline.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Total QALY loss due to varicella in children and carers, for child assessed with CHU9 & EQ5D-5L and for parent with EQ5D-5L. For inpatient arm this is measured daily until discharge, once weekly for first month and then again at 6m. For community arm this is measured alternate days (although there is a diary every day)

Secondary outcome measures

We will collect data on disease severity using a previously validated assessment of varicella symptoms tool (Vázquez et al 2001), demographics, healthcare use, illness within the family unit and missed work/education days. We will estimate the financial and societal costs for families through a daily diary inquiring about medication use, additional childcare costs and days of work missed.

Overall trial start date

01/10/2017

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male or Female, less than 18 years old.
2. Hospital arm: Currently have chickenpox or have had it during the last 21 days (12m for stroke).
3. Community arm: History of close exposure to active case of chickenpox or diagnosis of early disease
4. Informed consent obtained from the parent(s) / guardian with assent in children >6 years.

Participant type

All

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Only those for whom admission is felt to be clinically unrelated to recent varicella (e.g. injuries / new malignant diagnosis) should be excluded from the study.

Recruitment start date

01/03/2018

Recruitment end date

01/09/2020

Locations

Countries of recruitment

Portugal, United Kingdom

Trial participating centre

Bristol Children's Hospital
Upper Maudlin Street.
Bristol
BS2 8AE
United Kingdom

Trial participating centre

Hospital Pediátrico de Coimbra
Aevnida, R. Dr. Afonso Romão,
Coimbra
3000-602
Portugal

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
University of Bristol
One Cathedral Square
Bristol
BS1 5DD
United Kingdom
0117 428 4011
research-governance@bristol.ac.uk

Sponsor type

University/education

Website

www.bristol.ac.uk/red

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

It is anticipated that this research will lead to publications in a journals covering the areas of paediatric infectious disease or vaccine research. Interim results are planned to be shared with the JVCI and presented at the ESPID summer 2020 meeting with final results in 2020.

Participating families will be asked if they would like to receive a copy of the final report.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/03/2019: Trial’s existence confirmed by NHS HRA