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

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

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


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

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

  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)

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


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals



State of Ethics Review Approval


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 & 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.

+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

Secondary study sponsor (If any)







Trial Completion details


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