Behavioral modifications in stroke patients through education

Recruiting

Conditions: Hemiplegia, unspecified, (2) ICD-10 Condition: G811||Spastic hemiplegia,

Registration Number: CTRI/2017/09/009600

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Recurrent stroke, cardiovascular morbidityand mortality are important causes of poor outcome in patients with indexstroke. According to INTERSTROKE study 80% of stroke are preventable due topresence of modifiable risk factors. However lack of knowledge that stroke andcardiovascular diseases are preventable is major hurdle to reduce the incidenceof recurrent stroke and cardiovascular morbidity. This is further compounded bythe non-compliance to medications, exercises smoking cessationand otherlifestyle modifications.

Stroke awareness has proven to be useful inimproving early arrival of stroke patients to emergency thus increasing thethrombolysis rates. Early stroke prevention education using print andaudio-visual media may be useful. In addition the use of pervasive mobile phoneplatform may help us reach patients during multiple intervals in a timelymanner.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 5830

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31): AIIMS Bhubaneswar
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Cuttack, ORISSA, India
All India Institute for Medical Sciences and Technology
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West, DELHI, India
Amrita Institute of Medical Sciences and Research Centre
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Ernakulam, KERALA, India
Bangur Institute of Neurology
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Kolkata, WEST BENGAL, India
Baptist Christian Hospital, Tezpur, Assam
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Sonitpur, ASSAM, India
BGS Global Hospital, Bangalore
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Bangalore, KARNATAKA, India
Care HospitalsHyderabad
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Hyderabad, ANDHRA PRADESH, India
Christian Medical College and Hospital
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Ludhiana, PUNJAB, India
Christian Medical College, Vellore
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Vellore, TAMIL NADU, India
Fortis Escorts Hospital Jaipur
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Jaipur, RAJASTHAN, India
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AIIMS Bhubaneswar
🇮🇳Cuttack, ORISSA, India
Dr Sanjeev Kumar Bhoi
Principal investigator
9919787978
neuro_sanjeev@aiimsbhubaneswar.edu.in