CTRI

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CTRI Number

CTRI/2017/09/009600 [Registered on: 01/09/2017] Trial Registered Prospectively

Last Modified On:

17/08/2021

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Process of Care Changes

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Behavioral modifications in stroke patients through education

Scientific Title of Study

Secondary prevention by structured semi-interactive stroke prevention package in India (SPRINT - INDIA)

Trial Acronym

SPRINT

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jeyaraj D Pandian
Designation	Professor and Head
Affiliation	Christian Medical College and Hospital
Address	Department of Neurology, Christian Medical College and Hospital Ludhiana PUNJAB 141008 India
Phone	9915784750
Fax	0161-2220850
Email	jeyarajpandian@hotmail.com

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Jeyaraj D Pandian
Designation	Professor and Head
Affiliation	Christian Medical College and Hospital
Address	Department of Neurology, Christian Medical College and Hospital Ludhiana PUNJAB 141008 India
Phone	9915784750
Fax	0161-2220850
Email	jeyarajpandian@hotmail.com

Details of Contact Person
Public Query
Modification(s)

Name	Dr Jeyaraj D Pandian
Designation	Professor and Head
Affiliation	Christian Medical College and Hospital
Address	Department of Neurology, Christian Medical College and Hospital Ludhiana PUNJAB 141008 India
Phone	9915784750
Fax	0161-2220850
Email	jeyarajpandian@hotmail.com

Source of Monetary or Material Support

Indian Council of Medical Research, New Delhi

Primary Sponsor

Name	Indian Council of Medical Research
Address	Indian Council of Medical Research Ansari Nagar, New Delhi, India 110029
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 31
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sanjeev Kumar Bhoi	AIIMS Bhubaneswar	Sijua, Patrapada, Bhubaneswar, Odisha 751019 Cuttack ORISSA	9919787978 neuro_sanjeev@aiimsbhubaneswar.edu.in
Dr M V Padma Srivastava	All India Institute for Medical Sciences and Technology	Department of Neurology, room no 708, 7th floor, All India Institute of Medical Sciences Ansari Nagar, Aurobindo Marg, New Delhi-110029, Delhi. South West DELHI	9810819167 vasanthapadma123@gmail.com
Dr Vivek Nambiar	Amrita Institute of Medical Sciences and Research Centre	Amrita Institute of Medical Sciences and Research Centre, AIMS Ponekkara, P. O Kochi, Kerala 682 041 Ernakulam KERALA	9400315050 vivek19602@aims.amrita.edu
Dr Biman Kanti Roy	Bangur Institute of Neurology	Department of Neurology, Bangur Institute of Neurology, 52/1A, Sambhu Nath Pandit Street, Bhawanipur, Kolkata, West Bengal 700025 Kolkata WEST BENGAL	9433185327 biman.kanti@rediffmail.com
Dr Sherly Mary Abharam	Baptist Christian Hospital, Tezpur, Assam	Department of Neurology, Baptist Christian Hospital, Chariali Tezpur Assam 784001,Sonitpur Sonitpur ASSAM	9678235423 sherlymsmhc@gmail.com
DR MADHUSUDHAN BK	BGS Global Hospital, Bangalore	department of Neurology, BGS Global Hospital, 67, Uttarahalli Road, Fort Kengeri, Bengaluru, Karnataka 560060 Bangalore KARNATAKA	9902078244 drmadhubk@gmail.com
Dr Y Muralidhar Reddy	Care Hospitals Hyderabad	Department of Neurology,Care Hospitals, Banjara Hills, Hyderabad Hyderabad ANDHRA PRADESH	9912329342 muralidharnims@gmail.com
Dr Jeyaraj D Pandian	Christian Medical College and Hospital	Department of Neurology, CMC Ludhiana,Brown Road, Punjab, India, 141008, Ludhiana,PUNJAB. Ludhiana PUNJAB	9915784750 jeyarajpandian@hotmail.com
Dr Sanjith Aaron	Christian Medical College, Vellore	Department of Neurological Sciences, Christian Medical College and Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 Vellore TAMIL NADU	9894022395 drsanjith@yahoo.co.uk
Dr Neetu Ramrakhiani	Fortis Escorts Hospital Jaipur	Jawahar Lal Nehru Marg, Sector 5, Malviya Nagar, Jaipur, Rajasthan 302017 Jaipur RAJASTHAN	9314932648 neetudilip@yahoo.co.in
Dr N V Sundrachary	Government General Hospital, Guntur	Department of Neurology, Government General Hospital,Guntur, Andhra Pradesh 522001 Guntur ANDHRA PRADESH	8632218675 sundarachary@yahoo.com
Dr Pawan Ojha	Grant Govt. Medical College & Sir J. J. Group of Hospitals	J J Marg, Nagpada, Mumbai Central, Mumbai, Maharashtra 400008 Mumbai MAHARASHTRA	9820523745 ptojha@yahoo.co.in
Dr Sulena	Guru Gobind Singh Medical College Faridkot	Sadiq Rd, Kotakpura, GGS Medical Hospital, Faridkot, Punjab 151203 Faridkot PUNJAB	7087907025 sulenasingh@yahoo.co.in
Dr Nomal Chandra Borah	Guwahati Neurological Research Centre	Department of Neurology, Guwahati Neurological Research Centre, Dispur, Guwahati-781006,Kamrup, ASSAM Kamrup ASSAM	9706050235 ncborah@usa.net
Dr Sudhir Sharma	Indira Gandhi Medical College Shimla	Ridge Sanjauli Rd, Lakkar Bazar, Shimla, Himachal Pradesh 171001 Shimla HIMACHAL PRADESH	9418523202 sharmasudhir21@gmail.com
Dr Abhishek Pathak	Institute of Medical Sciences, BHU, Varanasi	Aurobindo Colony, Banaras Hindu University Campus, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH	8948512666 abhishekpathakaiims@gmail.com
Dr Jayanta Roy	Institute of Neurosciences, Kolkata	185, Acharya Jagadish Chandra Bose Rd, Elgin, Kolkata, West Bengal 700017 Kolkata WEST BENGAL	9831195654 jroyneuro01@gmail.com
DR SUNIL K NARAYAN	Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry	Department of Neurology, SS Block, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Puducherry-6 Pondicherry PONDICHERRY	04132297280 sunil.narayan@jipmer.edu.in
Dr Saroja A O	Jawaharlal Nehru Medical College, KLE Academy of Higher Education & Research, Belagavi, Karnataka	JNMC Campus, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA	9448468474 sarojaao2002@yahoo.com
Dr Aparna R Pai	Kusturba Medical College and Hospital Manipal	Department of Neurology, Kusturiba Medical College and Hospital, SH 65, Madhav Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA	9880182224 aparna.pai@manipal.edu
Dr P Vijaya	Lalitha Super Specialty Hospital, Guntur	Department of Neurology, Lalitha Super Specialty Hospital Kothapet , Gowri Sankar Theatre Road, Guntur - 522001 Andhra Pradesh Guntur ANDHRA PRADESH	9440808621 vijayapvr@yahoo.com
Dr Vikram Huded	Narayana Hrudayalaya Hospital Bangalore	Narayana Hrudayalaya Hospital,NH Institute of Neurosciences, NH Mazumdar Shaw Medical Center, #258/A, Bommasandra, Anekal Taluk,Â Bangalore , Karnataka, India 560099Â Bangalore KARNATAKA	9900002101 drvikramhuded@gmail.com
Dr Girish Baburao Kulkarni	National Institute of Mental Health and Neuro Sciences	Department of Neurology, National Institute of Mental Health and Neuro Sciences, Hosur Road, Lakkasandra, Bengaluru, Karnataka 560029 Bangalore KARNATAKA	9035160614 gbk5000@rediffmail.com
Subash Kaul	Nizam Institute for Medical Sciences Hyderabad	Department of Neurology, Nizam Institute for Medical Sciences Punjagutta, Hyderabad-500082, Andhra Pradesh Hyderabad ANDHRA PRADESH	9848043329 subashkaul@hotmail.com
Dr Dheeraj Khurana	Post Graduate Institute for Medical Sciences and Research Chandigarh	Department of Neurology,Room No.18,A Block, Ground Floor, Post Graduate Institute for Medical Sciences and Research, Sector 12, Chandigarh, 160012 Chandigarh CHANDIGARH	9815066990 dherajk@yahoo.com
Dr S Kumaravelu	Ramesh Hospitals Guntur	Department o Neurology, Ramesh Hospitals, Nagarampalem Rd, Kanna Vari Thota, Guntur, Andhra Pradesh 522004 Guntur ANDHRA PRADESH	9553651777 neurovelu@gmail.com
DR PN Sylaja	Sree ChitraTirunal Institute for Medical Sciences and Technology Trivandrum	Department of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram-695011, Kerala Thiruvananthapuram KERALA	91-471-2446433 sylajapn@hotmail.com
Dr Thomas Mathew	St Johns Medical College Hospital Bengaluru	Department of Neurology, St Johns Medical College Hospital,Sarjapur Road, Opp BDA Complex, Bengaluru, Karnataka 560034 Bangalore KARNATAKA	9880247582 chakkuthom@hotmail.com
Dr Gaurav Mittal	St. Stephens Hospital, New Delhi	Department of Neurology, St. Stephens Hospital, Tis Hazari Marg, New Delhi- 110401 India. North DELHI	7042877975 drgkmittal@gmail.com
Dr Anand Vaishnav	Vadodara Stroke Center Vadodara	Department of Neurology, Vadodara Stroke Center, Vadodara Institute of Neurological Sciences, 99, Productivity Road, Urmi Society, Opp. ESI Hospital, Vadodara, Gujarat 390020 Vadodara GUJARAT	7600049554 vadodarastrokeclinic@gmail.com
Dr Arvind Shrama	Zydus Hospitals Ahmedabad	Department of Neurology, Zydus Hospitals, Nr. Sola Bridge, S.G. Highway Thaltej, Ahmedabad, Gujarat 380054 Ahmadabad GUJARAT	9409210486 dr_arvind10@yahoo.co.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 31
Name of Committee	Approval Status
ETHICAL COMMITTEE OF AMRITA	Approved
ETHICAL COMMITTEE OF IMS BHU, VARANASI	Approved
ETHICAL COMMITTEE OF INSTITUTE OF NEUROSCIENCES	Approved
ETHICS COMMITTEE OF BAPTIST CHRISTIAN HOSPITAL TEZPUR	Approved
ETHICS COMMITTEE OF LALITA SUPERSPECIALITY HOSPITAL	Approved
ETHICS COMMITTEE OF ST. STEPHENS HOSPITAL	Approved
ETHICS COMMITTEE ZYDUS HOSPITAL	Approved
INSTITUTE ETHICS COMMITTEE OF AIIMS	Approved
INSTITUTE ETHICS COMMITTEE PGIMER	Approved
INSTITUTE ETHICS COMMITTEE, JIPMER	Approved
INSTITUTINAL REVIEW BOARD, CMC, VELLORE	Approved
INSTITUTIONAL ETHICS COMMITTEE BGS GLOBAL HOSPITAL	Approved
INSTITUTIONAL ETHICS COMMITTEE DR RAMESH CARDIAC AND MULTIDISCIPLINARY HOSPITAL P LTD	Approved
INSTITUTIONAL ETHICS COMMITTEE NIZAM INSTITUTE OF MEDICAL SCIENCES	Approved
INSTITUTIONAL ETHICS COMMITTEE OF AIIMS, BHUBANESWAR	Approved
INSTITUTIONAL ETHICS COMMITTEE OF BANGUR INSTITUTE OF NEUROLOGY	Approved
INSTITUTIONAL ETHICS COMMITTEE OF FORTIS ESCORTS, JAIPUR	Approved
INSTITUTIONAL ETHICS COMMITTEE OF GGMC	Approved
INSTITUTIONAL ETHICS COMMITTEE OF GGSMC, FARIDKOT	Approved
INSTITUTIONAL ETHICS COMMITTEE OF GNRC	Approved
INSTITUTIONAL ETHICS COMMITTEE OF IGMC, SHIMLA	Approved
INSTITUTIONAL ETHICS COMMITTEE OF KLE, BELAGAVI	Approved
INSTITUTIONAL ETHICS COMMITTEE, CARE HOSPITAL	Approved
INSTITUTIONAL ETHICS COMMITTEE, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL LUDHIANA	Approved
INSTITUTIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE AND HOSPITAL, MANIPAL	Approved
INSTITUTIONAL ETHICS COMMITTEE, SCIMST	Approved
INSTITUTIONAL ETHICS REVIEW BOARD, ST. JOHNS MEDICAL COLLEGE AND HOSPITAL	Approved
INSTITUTIONAL HUMAN ETHICS COMMITTEE OF GOVERNMENT GENERAL HOSPITAL GUNTUR	Approved
NARAYANA HEALTH MEDICAL ETHICS COMMITTEE	Approved
NIMHANS ETHICS COMMITTEE	Approved
VADODARA ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	ALL STROKE PATIENTS, (1) ICD-10 Condition: G819\|\|Hemiplegia, unspecified, (2) ICD-10 Condition: G811\|\|Spastic hemiplegia,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	standard post stroke care	control group will receive standard of care as per current guidelines alone.
Intervention	Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines.	structured semi-interactive stroke prevention package

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Age â‰¥18 years (at the time of suffering stroke) including both men and women and there is no upper age limit 2. First ever Ischemic stroke or intracerebral haemorrhage 3. Between 2 days-3 months of stroke symptom onset 4. Modified Rankin scale score â‰¥2 at the time of enrolment

ExclusionCriteria

Details

1. Modified Rankin scale score 0 and 1 at the time of enrolment
2. Limited internet and/or mobile accessibility due to travel
3. Patients having active malignancies needing intensive therapy
4. Patients with terminal illness with an anticipated lifespan of less than 1 year
5. Patients with heart failure admitted more than twice in last six months
6. Patients with current psychiatric illness with loss of insight and suicide attempts
7. Patients with cerebral venous sinus thrombosis, aneurysmal subarachnoid hemorrhage, isolated central nervous system vasculitis and systemic vasculitis

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Centralized

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Primary outcome measure is a composite endpoint of recurrent stroke, high-risk transient ischemic attack, acute coronary syndrome, and death.	1 year

Secondary Outcome

Outcome	TimePoints
secondary outcome measures are blood pressure (mmHg), fasting blood glucose (mg/dl), LDL Cholesterol (mg/dl), triglycerides (mg/dl), smoking cessation (No/ total %), alcohol cessation, body mass index, physical activity MET (min/week), medication adherence and modified Rankin scale (mRS)	1 year

Target Sample Size
Modification(s)

Total Sample Size="5830"
Sample Size from India="5830"
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)
Modification(s)

28/04/2018

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
Modification(s)

Years="5"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

the main results will be published under the trial name INSTRuCT collaborators

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome in patients with index stroke. According to INTERSTROKE study 80% of stroke are preventable due to presence of modifiable risk factors. However lack of knowledge that stroke and cardiovascular diseases are preventable is major hurdle to reduce the incidence of recurrent stroke and cardiovascular morbidity. This is further compounded by the non-compliance to medications, exercises smoking cessationand other lifestyle modifications.

Stroke awareness has proven to be useful in improving early arrival of stroke patients to emergency thus increasing the thrombolysis rates. Early stroke prevention education using print and audio-visual media may be useful. In addition the use of pervasive mobile phone platform may help us reach patients during multiple intervals in a timely manner.

We aim to use structured semi-interactive stroke prevention package to reduce the risk of recurrent strokes, myocardial infarction and death in patients with sub-acute stroke after one month.