Quality of life effects of chickenpox on children and their families
| ISRCTN | ISRCTN15017985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15017985 |
| Secondary identifying numbers | 1.3 |
- Submission date
- 20/03/2019
- Registration date
- 25/03/2019
- Last edited
- 19/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 January 2023
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
Contact information
Scientific
Level 6, UHBristol Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
 ORCID ID |
0000-0002-3192-3102 |
|---|---|
| Phone | 0117 3420172 |
| robin.marlow@bristol.ac.uk |
Scientific
Centro Hospitalar e Universitário de Coimbra - Hospital Pediátrico
Coimbra
3000-602
Portugal
| ORCID ID |
0000-0002-5820-5215 |
|---|---|
| Phone | +351 239 488 700 |
| rodriguesfmp@gmail.com |
Study information
| Study design | International multi-centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format please use contact details to request a participant information sheet. |
| 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 |
| Study acronym | QoLPox |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2017 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 435 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- England
- Portugal
- United Kingdom
Study participating centres
Bristol
BS2 8AE
United Kingdom
Coimbra
3000-602
Portugal
Sponsor information
University/education
Research and Enterprise Development
University of Bristol
One Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | 0117 428 4011 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | www.bristol.ac.uk/red |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 29/03/2023 | 30/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | Protocol for hospital arm only version 1.5 |
27/11/2019 | 20/11/2023 | No | No |
| Basic results | 19/03/2024 | No | No |
Additional files
- ISRCTN15017985 _Protocol_Hospital arm_v1.5_27Nov2019.pdf
- Protocol for hospital arm only
- ISRCTN15017985_BasicResults_corrected.pdf
Editorial Notes
19/03/2024: The basic results previously added was replaced with a corrected version.
20/11/2023: A protocol for the hospital arm has been uploaded.
17/11/2023: The following changes have been made:
1. A basic results summary has been uploaded.
2. The final enrolment number has been added from the results summary.
30/03/2023: Publication reference added.
27/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/12/2022 to 31/01/2023.
2. The plain English summary was updated to reflect these changes.
16/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 01/12/2021 to 01/12/2022.
2. The intention to publish date was changed from 01/06/2021 to 01/06/2023.
3. The plain English summary was updated to reflect these changes.
23/06/2021: The recruitment end date has been changed from 01/06/2021 to 01/12/2021.
28/09/2020: Intention to publish date changed from 01/06/2020 to 01/06/2021 and IPD sharing statement added.
23/09/2020: The recruitment end date was changed from 01/09/2020 to 01/06/2021.
23/06/2020: The overall trial end date has been changed from 01/12/2020 to 01/12/2021 and the plain English summary has been updated accordingly.
25/03/2019: Trial’s existence confirmed by NHS HRA
