Contact information
Type
Scientific
Primary contact
Dr Raveed Khan
ORCID ID
Contact details
17 Hillside Terrace
Tunapuna
0000
Trinidad and Tobago
raveed01@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of personalized written asthma action plans in the management of children with partly controlled asthma in Trinidad: A randomized controlled trial.
Acronym
Study hypothesis
Current study hypothesis as of 20/05/2013:
In a primary care setting among children with partly controlled asthma, the use of written asthma action plans reduces revisits for acute asthma care.
Previous study hypothesis until 20/05/2013:
In a primary care setting among children with recurrent admissions to the Emergency room for asthma, the use of written action plans (WAPs) reduces revisits for acute asthma care.
Please note that as of 20/05/2013, the following changes were made to the trial record:
1. The public title was previously "Reducing emergency room visits in children with asthma: a randomised controlled trial"
2. The scientific title was previously "Efficacy of personalised written asthma action plans in the reduction of emergency room revisits in children with recurrent admissions for asthma: a randomised controlled trial"
Ethics approval
University of the West Indies, Faculty of Medical Sciences Ethics Committee approved on the 30th November 2009
Study design
Interventional randomised double blind single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma
Intervention
Current interventions as of 20/05/2013:
Personalised written asthma action plan versus routine care. Total duration of treatment is 6 months with monthly follow up of both arms for 1 year.
Previous interventions until 20/05/2013:
Personalised written asthma action plan versus routine care. Total duration of treatment is 6 months with monthly follow up of both arms for 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of emergency room revisits, measured monthly
Secondary outcome measures
1. Number of unscheduled doctor visits, measured monthly
2. Number of school days missed, measured weekly
3. Number of night-time awakenings with symptoms, measured weekly
4. Mean change in peak expiratory flow rates, measured weekly
Overall trial start date
01/02/2010
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 20/05/2013:
1. Children with partly controlled asthma with a history of presenting to the Emergency Room (ER) or Paediatric clinic for acute treatment of bronchospasm in the preceding six months
2. Ability of the child and/or parent to follow written directions.
Previous inclusion criteria until 20/05/2013:
1. Children with more than one admission to the ER for acute asthma care in the preceding six months
2. Children and/or the parents able to follow written directions
3. Children aged 1 - 16 years, either sex
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
Current exclusion criteria as of 20/05/2013:
1. Uncontrolled asthmatics
2. Inability of child and/or parent to follow written directions
3. Presence of co-morbid respiratory illness
4. Children or parents already in possession of written/verbal plans or other asthma education material
5. Children who sought care outside of the Chaguanas paediatric outpatient clinic or Emergency Room department and
6. Previous enrolment in an asthma educational programme/study.
Previous exclusion criteria until 20/05/2013:
1. Uncontrolled asthmatics
2. Inability of the child and/or parent to follow written directions
3. Presence of co-morbid respiratory illness
4. Previous enrolment in an asthma educational program/study
Recruitment start date
01/02/2010
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Trinidad and Tobago
Trial participating centre
17 Hillside Terrace
Tunapuna
0000
Trinidad and Tobago
Sponsor information
Organisation
University of the West Indies (Trinidad and Tobago)
Sponsor details
Department of Paraclinical Sciences
Public Health and Primary Care Unit
Faculty of Medical Sciences
St. Augustine
-
Trinidad and Tobago
Rohan.Maharaj@sta.uwi.edu
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Trinidad and Tobago)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23902670
Publication citations
-
Results
Khan R, Maharaj R, Seerattan N, Babwah F, Effectiveness of personalized written asthma action plans in the management of children with partly controlled asthma in Trinidad: a randomized controlled trial., J. Trop. Pediatr., 2014, 60, 1, 17-26, doi: 10.1093/tropej/fmt063.