Condition category
Respiratory
Date applied
27/06/2014
Date assigned
27/06/2014
Last edited
17/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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
sophie.turnbull@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sophie Turnbull

ORCID ID

Contact details

School of Social & Community Medicine
Canynge Hall
39 Whatley Road Clifton
Bristol
BS8 2PS
United Kingdom
-
sophie.turnbull@bristol.ac.uk

Additional identifiers

EudraCT number

2014-000903-28

ClinicalTrials.gov number

Protocol/serial number

16891

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

Acronym

CHICO

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

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

Intervention

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

Other

Phase

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

01/07/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Clinicians:
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

Patient

Age group

Child

Gender

Both

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

01/07/2014

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Social & Community Medicine
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

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

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: http://www.ncbi.nlm.nih.gov/pubmed/26373406

Publication citations

Additional files

Editorial Notes