Home » Trials » SLCTR/2010/007
Selected aspects of quality and patient safety in management of asthmatic children and effectiveness of a health education intervention for caregivers in reducing recurrent attacks
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SLCTR Registration Number
SLCTR/2010/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Selected aspects of quality and patient safety in management of asthmatic children and effectiveness of a health education intervention for caregivers in reducing recurrent attacks
Public Title of Trial
Selected aspects of quality and patient safety in management of asthmatic children and effectiveness of a health education intervention for caregivers in reducing recurrent attacks
Disease or Health Condition(s) Studied
Asthma
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P45/05/2010 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya.)
What is the research question being addressed?
Will a health education intervention have any effect on, reducing frequency and severity of recurrent attacks, increase in knowledge on caregiving on asthmatic children and change in preventive practices.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Study setting - Paediatric wards of Gampaha and Negombo hospitals The study participants - caregivers of asthmatic children Selection of study and control group – Randomization will be carried out for the days of the study period. Either Gampaha or Negombo hospital will be allocated as the study group according to randomization for each day. The intervention will be carried out for the caregivers form the selected hospital for that particular day. The caregivers in the hospital which was not selected will be chosen as the control group. Intervention Study group – health education booklet will be given to caregivers of asthmatic children Control group – No health education booklet to be given to caregivers of asthmatic children
Inclusion criteria
Caregivers with a child of 2 to 12 years of age admitted for treatment of asthma and refered to follow a paediatric clinic at Negombo and Gampaha hospitals.
Exclusion criteria
1.Caregivers who cannot read Sinhalese language 2. Not willing to follow clinics at Negombo and Gampaha hospitals
Primary outcome(s)
|
1.
Proportion of children with recurrent attacks needing visits to GP/OPD/hospital during past three months |
[ After 3 months and 6 months. ] |
Secondary outcome(s)
|
1.
Mean score on knowledge of asthma in care givers |
[ After 3 months and 6 months ] |
|
2.
Proportion of children having compliance with treatment |
[ After 3 months and 6 months ] |
|
3.
Proportion of children with hospital admissions |
[ After 3 months and 6 months ] |
Target number/sample size
70 each to experimental and control groups
Countries of recruitment
Sri Lanka
Anticipated start date
2010-08-01
Anticipated end date
2011-04-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2010-05-18
Approval number
P45/05/2010
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. N.A.N. Perera
Registrar in Public Health Dept. of Public Health,
Faculty of Medicine, University of Kelaniya
0112953411,
0773084870
niranjalaperera@ymail.com
Contact Person for Public Queries
Dr. N.A.N. Perera
Registrar in Public Health Dept. of Public Health,
Faculty of Medicine, University of Kelaniya
0112953411,
0773084870
niranjalaperera@ymail.com
Primary study sponsor/organization
Dr. N.A.N Perera
Registrar in Public Health, Department of Pulic health, Faculty of Medicine, University of Kelaniya.
0773084870
niranjalaperera@ymail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
