Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study is exploring whether it is possible to implement a web-based intervention for improving treatment for children with severe cough and respiratory tract infection. While most respiratory infections resolve themselves without treatment, a very small number of children require hospital care (e.g. for pneumonia and bronchiolitis). In consultations it is often difficult to establish which children will develop serious complications. The CHICO intervention will use the child's unique state of being (during the consultation) to provide individualised information for both doctors and carers to reduce this uncertainty.

Who can participate?
GPs and prescribing nurses are eligible to recruit children who are aged between 3 months and 12 years coming in with cough and respiratory infection.

What does the study involve?
The clinician will ask the parent/carer and child several questions about the child's cough during the consultation. The parent/carer will be asked to respond to some questions about their child's illness and their interaction with health services once a week for up to 8 weeks or until their cough has gone. They will have the option to complete the follow-up online or by phone and on paper.

What are the possible benefits and risks of participating?
The parent/carer will be helping us understand what information is given to them about their child's cough and how to care for their child at home. Disadvantages may be that the weekly phone call and home questionnaire, or the online questionnaire, will take a few minutes to answer.

Where is the study run from?
The study is run from the following Clinical Commissioning Groups in the UK: Bath and North East Somerset, Bristol, Gloucestershire, South Gloucestershire, North Somerset, Swindon and Wiltshire.

When is the study starting and how long is it expected to run for?
July 2014 to April 2015.

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

Who is the main contact?
Miss Sophie Turnbull

Trial website

Contact information



Primary contact

Miss Sophie Turnbull


Contact details

School of Social & Community Medicine
Canynge Hall
39 Whatley Road Clifton
United Kingdom

Additional identifiers

EudraCT number

2014-000903-28 number

Protocol/serial number


Study information

Scientific title

A feasibility randomised controlled trial investigating the clinical and cost effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection



Study hypothesis

As this is a feasibility trial there is no hypothesis, however, the research aim is:

To assess the feasibility of implementing a web-based behavioural intervention to improve the approach to, and clinical management of, childhood RTI and the use of antibiotics.

Ethics approval

14/NW/1034; First MREC approval date 13/06/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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


Topic: Children, Primary Care; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases


We are recruiting 30 practices with 10 in reserve. We are randomising at the practice level as it is a cluster RCT. 15 practices will be randomised to each arm initially and we may randomise the 10 reserves depending on how recruitment is going.

The control practices will be asked to conduct their consultation as usual with the children eligible to enter the CHICO study and to record brief details about the child's signs, symptoms and demographics on the CHICO web-based system.

CHICO intervention, Findings across the TARGET Programme were synthesised using Greene and Kreuter's Precede-Proceed model, which integrates across a number of behavioural theories into a unified model. Key findings from each Workstream were used to produce a summary of the evidence fitted to this model, identifying the behavioural and environmental factors shown to influence the decision to prescribe in our research.
This model was used to formulate a number of evidence-based recommendations for the intervention.

Follow Up Length: 7 month(s); Study Entry: Multiple Randomisations

Intervention type



Not Applicable

Drug names

Primary outcome measures

Feasiblity; Timepoint(s): September 2014-September 2015

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

GPs and prescribing nurses are eligible to recruit children to the study.

GP practices will be included if they have at least Internet Explorer version 8 on their IT systems.

Children can be included into the study if they meet the following criteria:
1. Children aged =3 months and <12 years
2. Presenting with an acute RTI with cough for =28 days as a main symptom (including exacerbation of asthma)
3. Presenting with illnesses such as RTI and epilepsy or diabetes, including infective exacerbation of asthma (non-infective exacerbation of asthma is an exclusion criterion)

Target Gender: Male & Female; Upper Age Limit 11 years ; Lower Age Limit 3 months

Participant type


Age group




Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

Participant exclusion criteria

Children will not be eligible for the study if:
1. They are aged < 3 months or = 12 years.
2. The parent/carer/children are unable or unwilling to assist with study.
3. The child has already been successfully recruited to the CHICO study.
4. They present with acute non-infective exacerbations of asthma
5. They present with RTI without cough or symptoms >28 days
6. They are at greater risk of serious infection; they have chronic diseases/multi-morbidities that increase the risk of RTI complications.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

School of Social & Community Medicine
United Kingdom

Sponsor information


University of Bristol (UK)

Sponsor details

Senate House
Tyndall Avenue
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (UK); Grant Codes: SSCMRK7516

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in:

Publication citations

Additional files

Editorial Notes