| CTRI Number |
CTRI/2021/11/038137 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Capacity building of health system on prevention and management of snakebite envenomation |
|
Scientific Title of Study
|
ICMR National Snakebite Project (INSP) on capacity building of health system on prevention and management of snakebite envenomation including its complications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Gajbhiye |
| Designation |
Scientist D |
| Affiliation |
ICMR-NIRRH |
| Address |
Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224192036 |
| Fax |
|
| Email |
gajbhiyer@nirrh.res.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rahul Gajbhiye |
| Designation |
Scientist D |
| Affiliation |
ICMR-NIRRH |
| Address |
Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224192036 |
| Fax |
|
| Email |
gajbhiyer@nirrh.res.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rahul Gajbhiye |
| Designation |
Scientist D |
| Affiliation |
ICMR-NIRRH |
| Address |
Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224192036 |
| Fax |
|
| Email |
gajbhiyer@nirrh.res.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research National Task Force on Snakebite |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashikant Shambharkar |
Aheri Block Gandchiroli |
Aheri Block, Gadchiroli District Maharashtra Gadchiroli MAHARASHTRA |
9422141016
shashishambharkar@gmail.com |
| Dr Amarendra Mahapatra |
Kasipur Block |
Kasipur Block, Rayagada District Rayagada ORISSA |
9437694368
amarmaha@gmail.com |
| Dr Amarendra Mahapatra |
Khordha Block |
Khurdha Block,Orissa Khordha ORISSA |
9437694368
amarmaha@gmail.com |
| Dr Manohar Vitthalrao Bansode |
Shahapur Block |
Sub District Hospital Shahapur District Thane Thane MAHARASHTRA |
8424057421
drmvbansode1969aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ICMR-RMRC Instituttional Human Ethics Commitee |
Approved |
| NIRRH Ethics Committee for Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T630||Toxic effect of snake venom, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IEC materials, community lectures |
IEC materials in local language for the community, snake rescuers (Sarpa Mitra/snake friends) school teachers, panchayat members, and traditional healers. The IEC materials will include the following information:
- Pictures of the venomous snakes commonly found in the study area
- Knowledge about venomous and non-venomous snakes
- Symptoms of snakebite envenomation in simple non-medical terms in regional language
- Prevention of snakebites and first aid treatment
- Nearest health facility for snakebite treatment (distance in kms, contact numbers of health facilities), ambulance services 102,108 information
The IEC materials will be displayed at Schools, Gram Panchayat in villages, Anganawadi, Tribal Residential Schools, Block panchayat Office, Sub Centers, PHCs, CHCs.
Community meetings and Public talks:
- ICMR snakebite project staff, and primary health care workers (ASHA, ANM and MPW) will be trained to educate community through community meetings for creating awareness on prevention, first aid and early transport of snakebite patients to nearest health facility
|
| Intervention |
Training of healthcare workers |
Capacity building of Medical Officers (PHC, CHC, District Hospital):
- Team of National experts for snakebite management (Expert group STG, 2017) will provide training to master trainers and also provide technical support for regional training. [Dr Himmatrao Bawaskar and other experts who contributed for the development of STG, 2017 will provide training]
- Region wise snakebite experts will train the master trainers from each study site in Maharashtra and Odisha.
- Total 6 Master Trainers from each study site: 2 Master Trainers from State Public Health Department (Two Senior MOs from District Hospital and two MOs from CHC , 2 Senior faculties Medicine Department of linked Medical College will be trained.
 Periodic training of all Medical Officers working in public health system in study area will be conducted every 6 months.
 All medical officers will be provided copies of Training modules prepared as per the Standardized Treatment Guidelines (STG, 2017)
- Quick reference guide
- Snakebite treatment flyer
Capacity building of outreach health staff (ASHA, ANM, MPW other healthcare providers):
- Periodic Training (every 6 months for 2 years) of health care providers will be conducted on snakebite prevention, diagnosis and management
- Training will also focus on first aid skills, immobilization techniques, cardiopulmonary resuscitation (CPR) etc.
- Medical Officers trained by Master trainers will conduct the training program for ASHA, ANM, MPW and other healthcare providers at their respective health facilities.
- Training manuals for ASHA, ANM, MPW, and other healthcare providers developed by ICMR- NIRRH will be translated into regional languages
- Pre and post training evaluation to assess knowledge retention and assess impact of training
Quick reference charts as per STG (2017) on first aid and management of snakebite in English and regional languages will be displayed in OPD and indoor wards of PHC, CHC, in study area.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
62.00 Year(s) |
| Gender |
Both |
| Details |
Community Members
Medical Officers
Front line Health Workers |
|
| ExclusionCriteria |
| Details |
not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retrospective data
Facility survey
FGDs among community
Evaluation of the basic knowledge of MOs & other Healthcare providers on snakebite management
Capacity building of MOs & Health care Providers
Impact of the Capacity building |
Baseline Retrospective data FGD Facility survey
6 month Capacity building
12 months impact evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The results of the study will help in reducing the mortality and morbidity due to snakebites in selected regions in India and also useful for phase II implementation in other states having high burden of snakebites.
- The evidence generated from the study may be useful to the Government of India for developing National Strategies to reduce burden of on snakebites.
- Model clinical snakebite management centers can be established all over country based on the outcome of the study
|
24 month |
|
|
Target Sample Size
|
Total Sample Size="900" Sample Size from India="900"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On request to Principal Investigator/Director NIRRH after permission from ICMR
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Snakebite is a major public health problem in India leading to nearly 50,000 deaths every year. Snakebite affects mainly poor, agricultural and migrant workers, tribals, hunters and mainly earning family member. Lack of awareness, inadequate knowledge of prevention of snakebite and first aid amongst community as well as peripheral health care workers, delay in receiving lifesaving treatment [anti-snake venom (ASV)] and non-availability of trained medical officers for management of snakebite contribute to higher number of deaths. Earlier study conducted through Model Rural Health Research Unit (MRHRU) at Sub District Hospital Dahanu, District Palghar, Maharashtra reported higher incidence of snakebites in tribal area of Dahanu, lack of awareness on snakebites, inadequate knowledge on prevention and first aid amongst community and peripheral health care workers in Dahanu block. We also observed that none of the medical officers in Dahanu block were aware about National snakebite treatment protocol and there was no uniformity in giving treatment dose of ASV. Most of the medical officers were practising ASV skin test which is not recommended leading to wastage of precious ASV. We provided training to all the Medical Officers and also implemented National snakebite treatment protocol. Intense training was provided to ASHA, ANM, MPW on prevention and first aid for snakebites. The snake rescuers, local tantriks were also provided training on prevention, first aid and timely referral of snakebite cases to the nearest public health facility having ASV and trained manpower. A model has been established involving community, training of healthcare workers, implementation of National snakebite treatment protocol for reducing burden of snakebites. ICMR-National Task Force on snakebite recommended to upscale the model in selected districts of Maharashtra and Odisha States. The objectives of the proposed study are to empower the community on prevention, appropriate first aid, and early transfer of snakebite patients to nearest health facility for reducing the mortality and morbidity due to snakebites in selected districts in Maharashtra and Odisha. The culturally appropriate IECs, training manuals for outreach health worker (in regional languages), Training manuals for Medical Officers will be developed. The facility check assessment will also be carried out to understand ASVs distribution and utilization in selected regions of India. Interviews of outreach health care workers (ASHA,ANM,MPW) and Medical Officers will be conducted to understand the knowledge gaps. This would be crucial for planning appropriate and effective training in order to build the capacity of the health system in different zones of India. The prospective data will be collected from health facilities in all study sites for one year period and implementation of STG for snakebite treatment will be monitored regularly. The impact evaluation of the capacity building will also be carried out. The results of this study will be useful for expansion of the study at National level. The study will be useful for providing inputs for National Snakebite Management Protocol relevant to public health system taking into consideration regional differences in India. The study will help in reducing the mortality and morbidity due to snakebites in selected regions in India. The study will empower the community and health system for prevention and improved management of snakebites in selected regions in India. The results of the study will be crucial for establishing centers of excellence for snakebite management in 2 study sites spread across two geographical zones. The evidence generated from the study may be useful to the Government of India and other agencies for developing Strategies to reduce burden of snakebites. |