The CHICO (Children with Cough) trial
| ISRCTN | ISRCTN23547970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23547970 |
| Clinical Trials Information System (CTIS) | 2014-000903-28 |
| Protocol serial number | 16891 |
| Sponsor | University of Bristol (UK) |
| Funder | National Institute for Health Research (UK); Grant Codes: SSCMRK7516 |
- Submission date
- 27/06/2014
- Registration date
- 27/06/2014
- Last edited
- 12/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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 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 asks the parent/carer and child several questions about the child's cough during the consultation. The parent/carer is 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 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
Contact information
Scientific
School of Social & Community Medicine
Canynge Hall
39 Whatley Road Clifton
Bristol
BS8 2PS
United Kingdom
| sophie.turnbull@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 acronym | CHICO |
| Study objectives | 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(s) | First MREC approval date 13/06/2014, ref: 14/NW/1034 |
| Health condition(s) or problem(s) studied | Topic: Children, Primary Care; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases |
| Intervention | 30 practices are recruited with 10 in reserve. Randomisation at the practice level as it is a cluster RCT. 15 practices will be randomised to each arm initially and the 10 reserves may be randomised 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 |
| Primary outcome measure(s) |
Feasiblity; Timepoint(s): September 2014-September 2015 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2014 |
| Date of final enrolment | 30/04/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BS8 2PS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/05/2017 | Yes | No | |
| Protocol article | protocol | 15/09/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/05/2017: Publication reference added.
