| 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 (in lay language) | Selected aspects of quality and patient safety in managment of asthmatic children and effectiveness of a health education intervention for caregivers in reducing recurrent attacks | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Asthma | |
| What is the research question being addressed? | Will a health education intervention have any effect on reducing freequancy and severity of recurrent attacks, increase in knowledge on caregiving on asthmatic children and change in preventive practices? | |
| Study design | Study design- Randomized controled clinical trial 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 Control group – No health education booklet |
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| Intervention(s) planned | 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 |
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| Target number / sample size | 70 each to experimental and control groups | |
| Primary outcome(s) | Proportion of children with recurrent attacks needing visits to GP/OPD/hospital during past three months | |
| Primary outcome(s) - time of assessment(s) | After 3 months and 6 months. | |
| Secondary outcome(s) | 1.Mean score on knowledge of asthma in care givers 2.Proportion of children having compliance with treatment 3. Proportion of children with hospital admissions |
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| Secondary outcome(s) - time of assessment(s) | After 3 months and 6 months | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/08/2010 | |
| Anticipated end date | 01/04/2011 | |
| Recruitment status | Pending | |
| State of ethics review approval | Granted ethical clearance by Ethics Review Committee, Faculty of Medicine, University of Kelaniya | |
| Funding source(s) | None | |
| Applicant's Email | niranjalaperera@ymail.com | |
| Approval Status | Approved | |
| 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 |
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| Primary Study Sponsor/ Organization | Dr. N.A.N. Perera
Dept. of Public Health, Faculty of Medicine, University of Kelaniya 0112953411, 0773084870 niranjalaperera@ymail.com |
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| Contact Person for Public Queries | Dr. N.A.N. Perera Registrar in Public Health Dept. of Public Health, Faculty of Medicine, University of Kelaniya 0773084870 niranjalaperera@ymail.com |
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| Secondary Study Sponsor(s), (if any) | None |
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