Condition category
Respiratory
Date applied
04/10/2007
Date assigned
16/10/2007
Last edited
11/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Terry Klassen

ORCID ID

Contact details

Aberhart Centre One
Room 8213
11402 University Avenue
Edmonton
T6G 2J3
Canada

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 measures

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

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

http://www.ualberta.ca/

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

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24204974

Publication citations

  1. 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.

Additional files

Editorial Notes