Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CCT (Croup Communication Tools) Study
Study hypothesis
Stories, delivered through printed and illustrated story booklets, versus standard information sheets distributed in the Emergency Department (ED), will produce different results in terms of:
1. Parental anxiety, knowledge, satisfaction, and decisional regret
2. Healthcare utilisation patterns, and
3. Costs
Please note that as of 05/09/2008, the anticipated end date of this trial was extended to 31st March 2009 to create more time to recruit the full sample size. The previous anticipated end date was 31st March 2008.
Ethics approval
Approved by University of Alberta Health Research Ethics Board on the 14th September 2007 (ref: B-110607).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Acute obstructive laryngitis (croup)
Intervention
Patients are randomly assigned to one of the following:
1. Experimental intervention is three booklets that integrate stories, as told by parents of children with croup attending the ED, with evidence regarding the epidemiology and treatment of the condition. These will be given when they are recruited and randomised at the beginning of their ED visit. They will be able to take the information home and refer to it at their convenience. Parents will be interviewed when they are recruited to the study (baseline), on discharge from the ED, one day post-ED discharge and three days post-ED discharge. For patients who still have symptoms at day three, the parents will be interviewed every two days until the symptoms resolve or until 9 days post-discharge. A convenience sample of 30 parents randomised to the story group will be asked to participate in an in-depth qualitative interview approximately 2 weeks after the ED visit. All parents will be interviewed at 1 year post-ED visit
2. Control intervention is a standard patient information sheet on croup
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Parental anxiety measured using the State-Trait Anxiety Inventory (STAI-S, Form Y). Anxiety will be measured at baseline, discharge from ED, one day post-discharge, and when child is symptom free.
Secondary outcome measures
1. Event impact
2. Parental knowledge, measured at day 3 post-discharge, 1 year post-discharge
3. Parental satisfaction with ED visit, measured at day 1 post-discharge
4. Decisional regret, measured at day 1 post-discharge
5. Incidence of return for medical care, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge
6. Healthcare utilisation patterns, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge, 1 year post-discharge
7. Costs, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge, 1 year post-discharge
Overall trial start date
15/10/2007
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parents of children with a clinical diagnosis of croup
2. Parents must also meet the following criteria:
2.1. Have a telephone and be willing to be contacted for follow-up interviews
2.2. Fluent in English
2.3. Provide informed consent
2.4. No prior visit to an ED during this episode of the disease
2.5. No prior visit to an ED for another episode of croup during the study period
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant exclusion criteria
Parents will be excluded if:
1. Stridor is due to another cause (e.g., bacterial tracheitis, presence of a supraglottic foreign body)
2. Parent has previously been included in the study
Recruitment start date
15/10/2007
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Aberhart Centre One, Room 8213
Edmonton
T6G 2J3
Canada
Sponsor information
Organisation
University of Alberta (Canada) - Department of Paediatrics
Sponsor details
Aberhart Centre One
11402 University Avenue
Edmonton
T6G 2J3
Canada
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Alberta (Canada) - Department of Paediatrics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24204974
Publication citations
-
Results
Hartling L, Scott SD, Johnson DW, Bishop T, Klassen TP, A randomized controlled trial of storytelling as a communication tool., PLoS ONE, 2013, 8, 10, e77800, doi: 10.1371/journal.pone.0077800.