Condition category
Respiratory
Date applied
25/10/2010
Date assigned
17/11/2010
Last edited
26/03/2014
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 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 measures

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

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

http://sta.uwi.edu/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23902670

Publication citations

  1. 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.

Additional files

Editorial Notes