NCT03228979

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,830

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

April 28, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

3.9 years

First QC Date

February 3, 2017

Last Update Submit

July 26, 2021

Conditions

Stroke

Keywords

Secondary Prevention PackageEducation

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular event

    Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.

    One year.

Secondary Outcomes (11)

  • Systolic Blood Pressure (mmHg)

    One year.

  • Fasting Blood Glucose (mg/dl)

    One year.

  • LDL Cholesterol (mg/dl)

    One year.

  • Triglycerides (mg/dl)

    One year.

  • Smoking cessation (No/ total %)

    One year.

  • +6 more secondary outcomes

Study Arms (2)

Structured Semi-Interactive Prevention

ACTIVE COMPARATOR

The intervention arm will receive a 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

Other: Structured Semi-Interactive Stroke Prevention Package

Control group

NO INTERVENTION

Patients will receive standard post stroke care for 1 year

Interventions

Structured Semi-Interactive Stroke Prevention PackageOTHER

The intervention arm will receive a 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 Prevention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and above including both men and women
  • First-ever Ischemic stroke or intracerebral haemorrhage
  • Between 2 days-3 months of stroke symptom onset
  • Computed Tomography /Magnetic Resonance Imaging shows recent stroke (infarct and/or hemorrhage)
  • Able to read and complete simple tasks suggested in the stroke workbook if having aphasia or is illiterate, a caregiver is available to read for the patients and complete the reading/workbook tasks for the patients.
  • Able to read and possess a working personal mobile cellular device. In case of patients who is not able to read and/or don't have a personal mobile cellular device or unable to use it, a caregiver is available all times who is able to use mobile cellular devices and read to the patient.
  • Able to watch health education videos on a video player on cellular device or any other video player available to the patient.
  • Able to come for follow up visits for at least 1 year
  • Able to provide signed informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

RECRUITING

Related Publications (7)

  • Chow CK, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis GS. Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol. BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012.

    PMID: 22267690BACKGROUND

  • Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.

    PMID: 26486857BACKGROUND

  • Kumaravelu S, Verma SJ, Arora R, Arora D, Arya Devi KS, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray B, Nambiar V, Aaron S, Mittal G, Nagarjunakonda S, Pai A, Reddy YM, Narayan S, Borah N, Das R, Kulkarni G, Huded V, Mathew T, Srivastava MVP, Bhatia R, Ojha P, Roy J, Abraham S, Vaishnav A, Sharma A, Jabeen SA, Pathak A, Bhoi S, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi S, Kate M, George T, Sebastian I, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. SPRINT INDIA: Regional Variations in Primary and Secondary Stroke Outcomes Based on Baseline Characteristics in North and South Indian Sites. Ann Indian Acad Neurol. 2025 May 1;28(3):378-386. doi: 10.4103/aian.aian_792_24. Epub 2025 May 7.

    PMID: 40335450DERIVED

  • Verma SJ, Karuthedathu Mana Sanal Kumar AD, Arora D, Dhasan A, Sylaja PN, Khurana D, Vijaya P, Ray BK, Nambiar V, Aaron S, Mittal GK, Pai AR, Kumaravelu S, Reddy YM, Narayan S, Borah NC, Das R, Kulkarni GB, Huded V, Mathew T, Srivastava P, Bhatia R, Ojha PK, Roy J, Abraham SM, Vaishnav A, Sharma A, Pathak A, Bhoi SK, Sharma S, Sulena S, Saroja AO, Ramrakhiani N, Kempegowda MB, Gorthi SP, Kate MP, George T, Sebastian IA, Sharma M, Dhaliwal R, Huilgol R, Pandian JD. Comparing Stroke Profiles and Outcomes between Urban and Rural India: A Secondary Analysis of the SPRINT INDIA Trial. Cerebrovasc Dis. 2026;55(1):29-39. doi: 10.1159/000545675. Epub 2025 Apr 16.

    PMID: 40239637DERIVED

  • SPRINT INDIA trial collaborators. Secondary prevention with a structured semi-interactive stroke prevention package in INDIA (SPRINT INDIA): a multicentre, randomised controlled trial. Lancet Glob Health. 2023 Mar;11(3):e425-e435. doi: 10.1016/S2214-109X(22)00544-7.

    PMID: 36796986DERIVED

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

    PMID: 34813082DERIVED

  • Kate MP, Arora D, Verma SJ, Sylaja PN, Renjith V, Sharma M, Pandian JD; SPRINT India Collaborators. Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA) study protocol. Int J Stroke. 2020 Jan;15(1):109-115. doi: 10.1177/1747493019895653. Epub 2019 Dec 18.

    PMID: 31852411DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jeyaraj D Pandian, MD DM

    Christian Medical College and Hospital, Ludhiana, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeyaraj D Pandian, MD DM

CONTACT

9915784750jeyarajpandian@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded end-point clinical trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Study is a multicenter, randomized, parallel-design, adaptive and blinded end-point clinical trial of sub-acute stroke patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal and Professor, Department of Neurology

Study Record Dates

First Submitted

February 3, 2017

First Posted

July 25, 2017

Study Start

April 28, 2018

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana. Participants information will be identified only by their initials, date of birth and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as meta-analyses, reanalysis, or replication of results.

Locations

IN(1)