Home » Trials » SLCTR/2019/030
Burden of human leptospirosis and the effectiveness of an intervention to minimize delays in seeking treatment among patients in Monaragala district
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SLCTR Registration Number
SLCTR/2019/030
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Burden of human leptospirosis and the effectiveness of an intervention to minimize delays in seeking treatment among patients in Monaragala district
Public Title of Trial
A non-randomized controlled clinical trial on the effectiveness of an education based intervention in improving the knowledge on leptospirosis that would help minimise delays in seeking treatment among farmers in the Monaragala district
Disease or Health Condition(s) Studied
Leptospirosis
Scientific Acronym
None
Public Acronym
None
Brief title
An intervention to minimize delays related to awareness in seeking treatment of leptospirosis in the Monaragala district
Universal Trial Number
U1111-1239-3168
Any other number(s) assigned to the trial and issuing authority
EC - 18 - 066
What is the research question being addressed?
Will an education based intervention improve the knowledge on leptospirosis that would help minimise delays in seeking treatment, among farmers in the Monaragala District?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Study setting –Siyambalanduwa and Madulla MOH areas (the intervention group) and Wallawaya and Buttala MOH areas (non-intervention areas)
The educational interventions will be developed through the following process: 1. Situational analysis of the study area related to paddy cultivation, related to leptospirosis transmission, clinical features, prophylaxis and prevention. 2. Conducting focus group discussions with area agricultural officer, PHI, representatives from the Govisamithi, MOH and other relevant officers to identify the state of cultivation with time frame. 3. Creating health messages in the local language with expert opinion from health promotion bureau according to the health belief model, and emphasizing the need for reducing delays in seeking treatment for leptospirosis.
The following methods will be utilized for the delivery of the educational interventions:
1.Create SMS group among farmers to share SMS related to Leptospirosis Duration and frequency – 6 months / Weekly SMS will be sent
2.Announcements at “SathiPola” Duration and frequency – 6 months/ Weekly announcements
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Percentage improvement in knowledge of farmers attending Govisamithi meetings measured using pre and post questionnaire according to health belief model |
[ 6 months after the commencement of the intervention ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
Intervention group - 200 Non intervention group - 200
Countries of recruitment
Sri Lanka
Anticipated start date
2019-09-20
Anticipated end date
2020-02-27
Date of first enrollment
2019-09-10
Date of study completion
Recruitment status
Terminated
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2018-08-16
Approval number
EC-18-066
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. A.M.U.P.Kumari
Registrar in Community Medicine
Deputy Director General Non Communicable Disease unit (NCD Unit), Ministry of Health, Sri Lanka
Ministry of Health, 385, Ven. Baddegama Wimalawansa Thero Mawatha, Colombo 10.
+94773395675
abeykoonprabha@gmail.com
Contact Person for Public Queries
Dr. Jagath Amarasekare
Consultant Community Physician
Anti Malaria Campaign, Ministry of Health
Public Health Complex, Ministry of Health, Sri Lanka,
555/5 Elvitigala Mawatha, Colombo, Sri Lanka
+94779030706
jagthamarasekare@gmail.com
Primary study sponsor/organization
Epidemiology Unit, Ministry of Health, Sri Lanka
231 De Saram Place, Colombo 01000
www.epid.gov.lk › web
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
