Effectiveness of personalized written asthma action plans in the management of children with partly controlled asthma in Trinidad: A randomized controlled trial.
| ISRCTN | ISRCTN53955042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53955042 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/10/2010
- Registration date
- 17/11/2010
- Last edited
- 26/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Raveed Khan
Scientific
Scientific
17 Hillside Terrace
Tunapuna
0000
Trinidad and Tobago
| raveed01@hotmail.com |
Study information
| Study design | Interventional randomised double blind single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of personalized written asthma action plans in the management of children with partly controlled asthma in Trinidad: A randomized controlled trial. |
| Study objectives | 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(s) | University of the West Indies, Faculty of Medical Sciences Ethics Committee approved on the 30th November 2009 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2010 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- Trinidad and Tobago
Study participating centre
17 Hillside Terrace
Tunapuna
0000
Trinidad and Tobago
0000
Trinidad and Tobago
Sponsor information
University of the West Indies (Trinidad and Tobago)
University/education
University/education
Department of Paraclinical Sciences
Public Health and Primary Care Unit
Faculty of Medical Sciences
St. Augustine
-
Trinidad and Tobago
| Rohan.Maharaj@sta.uwi.edu | |
| Website | http://sta.uwi.edu/ |
"ROR" |
https://ror.org/003kgv736 |
Funders
Funder type
Other
Investigator initiated and funded (Trinidad and Tobago)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/02/2014 | Yes | No |
