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


SLCTR Registration Number


Date of Registration

09 Sep 2019

The date of last modification

Sep 09, 2019

Application Summary

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


Scientific Acronym


Public Acronym


Brief title

An intervention to minimize delays related to awareness in seeking treatment of leptospirosis in the Monaragala district

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

EC - 18 - 066

Trial Details

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


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice





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

  1. Create a desk calendar for general practitioners in Siyambalanduwa and Madulla area (As a tool to provide education to farmers of the intervention area) Duration and frequency – 6 months/ monthly The health messages will be delivered to farmers attending General Practice (GP) clinics in the intervention area. Key messages will be delivered to the farmers through the GPs via desk calendars containing a key message for each month.

Inclusion criteria

  1. Farmers registered at the Agricultural Office who attend Govisamithi meetings.
  2. Male and female farmers
  3. Farmer > 18 years of age

Exclusion criteria

  1. Farmers not registered at the Agricultural Office

Primary outcome(s)


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)




Target number/sample size

Intervention group - 200 Non intervention group - 200

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source


Regulatory approvals

State of Ethics Review Approval



Date of Approval


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 & Sponsor Information

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.



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



Primary study sponsor/organization

Epidemiology Unit, Ministry of Health, Sri Lanka

231 De Saram Place, Colombo 01000

www.epid.gov.lk › web

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results