Condition category
Musculoskeletal Diseases
Date applied
05/11/2015
Date assigned
05/11/2015
Last edited
15/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Arthritis is a common condition which causes pain, stiffness and swelling (inflammation) in the joints. Arthritis is usually associated with older people, but it can also affect children. Most cases of arthritis in children are known as juvenile idiopathic arthritis (JIA), because the cause is not known (idiopathic). In order to be diagnosed with JIA, one or more joints must be inflamed for more than 6 weeks, in a child under the age of 16. The condition can cause considerable pain and distress to the child however it also has a significant impact on their family. It can be incredibly stressful for parents having to be faced with their child’s pain and physical difficulties. The treatment of JIA is often complex, involving a number of different medications, hospital visits and physiotherapy, and some parents find it difficult to manage all of these aspects. There is a great deal of information available on the internet which can help parents to understand more about JIA. There is however a lack of resources which help parents to deal with the daily issues that they and their children could face. "WebParC" is a specially designed website which aims to help teach parents ways to cope, lowing their stress levels and improving their child’s wellbeing. The aim of this study is to find out whether using this web-based tool can help to lower stress levels in parents who have children suffering from JIA.

Who can participate?
Adults who have a child that has been diagnosed with JIA within the last six months.

What does the study involve?
Parents are randomly allocated to one of two groups. Those in the first group are given access to WebParC for the 12 months of the study. Their child also receives their normal medical care throughout this time. Parents in the second group are not given any access to WebParC however their child continues to receive their normal medical care. At the start of the study, and then again after 4 and 12 months, parents are asked to complete a number of questionnaires designed to measure their stress levels, how well they are coping with their child’s illness and how well they fell that their child is coping. Those that have access to the website will also complete questions regarding website usage.

What are the possible benefits and risks of participating?
If the website is effective, participants may benefit from enhanced parental ability to manage their child’s JIA, which will reduce parental stress and improve their children's quality of life. There are no known risks of taking part in the study.

Where is the study run from?
Approximately 18 children’s hospitals and clinics across England (UK)

When is the study starting and how long is it expected to run for?
July 2015 to June 2018

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

Who is the main contact?
Miss Pauline Whitelaw

Trial website

Contact information

Type

Public

Primary contact

Ms Pauline Whitelaw

ORCID ID

Contact details

Centre for Health Services Research
School of Health Sciences
City University of London
10 Northampton Square
London
EC1V 0HB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19872

Study information

Scientific title

Assessment of a web-based tool for parents of children with Juvenile Idiopathic Arthritis (JIA) coupled with standard care versus standard care alone: A randomised controlled trial

Acronym

WebParC

Study hypothesis

The aim of this study is to investigate the benefits of having access to the WebParC in combination with standard care when compared to standard care alone. The study help to determine the value of making an authorised website available on a larger scale and encouraging parents to access it as part of managing their child’s condition.

Ethics approval

London Bridge Research Ethics Committee, 14/10/2013, ref: 13/LO/0288

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children, Musculoskeletal disorders; Subtopic: All Diagnoses, Musculoskeletal (all Subtopics); Disease: All Diseases, Studies involving Children and Adolescents

Intervention

Participants are randomly allocated to one of two groups:

Group 1: Participants are given access to a specifically designed website (WebParC) for parents of children with Juvenile Idiopathic Arthritis for a period of 12 months, in addition to their child's normal clinical care. WebParC has been systematically developed with healthcare professionals and parents of children with JIA to provide techniques for dealing with the daily issues in JIA.
Group 2: Participants continue with standard care alone for the 12 month study period and are not given access to the web-based tool.

At baseline, 4 and 12 months, participants complete a number of questionnaires to assess their stress levels, how their are coping and their child's wellbeing.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Parental Stress is measured using the Paediatric Inventory for Parents (PIP) questionnaire at baseline, 4 and 12 months.

Secondary outcome measures

1. Parent effectiveness in managing their child's healthcare is assessed using the Effective Consumer Scale - Adapted (EC17-A) at baseline, 4 and 12 months
2. Parent self-efficacy in managing their child's arthritis is assessed using the Parent's Arthritis Self-Efficacy Scale (PASE) at baseline, 4 and 12 months
3. Parent coping is assessed using the Brief COPE at baseline, 4 and 12 months
4. Parent mood is assessed with the Hospital Anxiety and Depression Scale (HADS) at baseline, 4 and 12 months
5. Parent satisfaction with healthcare is assessed with the Client Evaluation of Service Questionnaire (CESQ) at baseline, 4 and 12 months
6. Child health-related quality of life is assessed with the parent administered version of the Child Health Questionnaire - PF50 (CHQ-PF50) at baseline, 4 and 12 months
7. Healthcare utilization is assessed by recording all contacts at the trial sites and with the Client Service Receipt Inventory (CSRI) questionnaire at baseline, 4 and 12 months
8. Dose-response relationship between the level of website usage and the primary and secondary outcomes, is determined by analysing website-based usage data at 12 months
9. Website usage is measured for the intervention group only at 4 and 12 months

Added 15/11/2016:
Process evaluation:
1. Illness beliefs in parents will be measured using the Brief Illness Perceptions Questionnaire (BIPQ) at baseline, 4 and 12 months
2. Acceptability will measured within a qualitative interview study using an topic guide based on an acceptability framework, on a small sample of parents from the intervention group (around 16 parents), randomly selected and invited to take part at 4 months
3. Website satisfaction and usage data will be assessed as part of the process evaluation by a satisfaction feedback questionnaire, administered to the intervention group at 4 and 12 months post randomisation
4. Context will be assessed by undertaking a survey assessing standard care across recruiting sites, and a survey of Clinical Nurse Specialists to give an overview of care packages delivered to patients and their families

Overall trial start date

01/07/2015

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents of children who have been newly diagnosed (within 6 months) with JIA according to internationally agreed criteria (Int. League against Rheumatism ILAR)
2. Aged 18 years or over
3. Ability to understand written and spoken English

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200; Description: The standard deviation of scores on the EC-17 is expected to be 17. Therefore, 79 households (118 parents) per groupwill be sufficient to detect a minimal clinically important difference of 7 points on this scale with 80% power at the 5% significance level, assuming an intra­-cluster correlation of 0.5.

Participant exclusion criteria

1. Identifiable psychosis or dementia in parents
2. Major problems with literacy making the completion of the questionnaires impossible
3. Too likely to be distressed by the study as judged by senior members of clinical staff

Recruitment start date

01/01/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Trial participating centre

Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

New Cross Hospital
Royal Wolverhampton NHS Trust Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

University Hospital of North Staffordshire
Newcastle Road
Stoke on Trent
ST4 6QG
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Alder Hey Children’s Hospital
E Prescot Rd
Liverpool
L14 5AB
United Kingdom

Trial participating centre

Birmingham Children's Hospital NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Great North Children's Hospital
Royal Victoria Infirmary Victoria Wing
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Leeds Children's Hospital
Leeds Teaching Hospital Clarendon Wing Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Nuffield Orthopaedic Centre
Oxford University Hospitals Windmill Road Headington
Oxford
OX3 7HE
United Kingdom

Trial participating centre

Southampton Children’s Hospital
119 Tremona Road
Southampton
SO16 6HU
United Kingdom

Trial participating centre

Addenbrooke's Hosptial
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Robert Jones and Agnes Hunt Orthopaedic Hospital
Gobowen
Oswestry
SY10 7AG
United Kingdom

Trial participating centre

Shrewsbury and Telford Hospital
Evolution Road
Shrewsbury
SY3 8XQ
United Kingdom

Sponsor information

Organisation

City University London

Sponsor details

Centre for Health Services Research
Northampton Square
London
EC1V 0HB
United Kingdom

Sponsor type

University/education

Website

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

Planned publication of a study protocol paper in June 2016 and results data in December 2018.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/11/2016: Royal Liverpool hospital has been removed from the list of trial participating centres and Alder Hey Children’s Hospital, Southampton Children’s Hospital; Addenbrooke's Hosptial, Robert Jones and Agnes Hunt Orthopaedic Hospital and Shrewsbury & Telford Hosptial have been added. In addition, the secondary outcome measures have been updated. 29/06/2016: The inclusion criteria section has been updated so that the participants are now parents of children with JIA diagnosed within six months rather than two months.