<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03228979</url>
  </required_header>
  <id_info>
    <org_study_id>SPRINT INDIA</org_study_id>
    <nct_id>NCT03228979</nct_id>
  </id_info>
  <brief_title>Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study</brief_title>
  <acronym>SPRINT</acronym>
  <official_title>Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christian Medical College and Hospital, Ludhiana, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Council of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Christian Medical College and Hospital, Ludhiana, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent stroke, cardiovascular morbidity and mortality are important causes of poor outcome&#xD;
      in patients with index stroke. According to the INTERSTROKE study, 80% of stroke are&#xD;
      preventable due to the presence of modifiable risk factors. However, the lack of knowledge&#xD;
      that stroke and cardiovascular diseases are preventable is a major hurdle to reduce the&#xD;
      incidence of recurrent stroke and cardiovascular morbidity. This is further compounded by the&#xD;
      non-compliance to medications, exercises smoking cessation and other lifestyle modifications.&#xD;
&#xD;
      Stroke awareness has proven to be useful in improving the early arrival of stroke patients to&#xD;
      emergency thus increasing the thrombolysis rates. Early stroke prevention education using&#xD;
      print and audio-visual media may be useful. In addition, the use of pervasive mobile phone&#xD;
      platform may help us reach patients during multiple intervals in a timely manner.&#xD;
&#xD;
      The study aims to use structured semi-interactive stroke prevention package to reduce the&#xD;
      risk of recurrent strokes, myocardial infarction and death in patients with sub-acute stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the second leading cause of death worldwide in 2010. In rural Maharashtra, it is&#xD;
      the leading cause of death. The Stroke incidence in India ranges from 135 to 145 per 100,000&#xD;
      population. From the recent Ludhiana population-based Stroke Registry and also from the&#xD;
      INSPIRE Registry 25% of the patients are below 49 years of age. Hypertension, smoking,&#xD;
      alcohol, diabetes, heart disease and lifestyle-related problems are the common causes of&#xD;
      stroke in India. Rheumatic heart disease and cerebral venous thrombosis are the main&#xD;
      etiologies of stroke in the young in our country.&#xD;
&#xD;
      Recurrent stroke&#xD;
&#xD;
      In an Oxfordshire Community Stroke Project reported in 1994, it was found that actuarial risk&#xD;
      of suffering a recurrence was 30% (95% confidence interval, 20% to 39%) by 5 years, about&#xD;
      nine times the risk of stroke in the general population. The risk was highest early after the&#xD;
      first stroke: 13% (95% confidence interval, 10% to 16%) by 1 year, 15 times the risk in the&#xD;
      general population. After the first year, the average annual risk was about 4%.&#xD;
&#xD;
      In the Copenhagen Stroke Study, stroke was recurrent in 23% despite most of these patients&#xD;
      being given prophylactic treatment prior to recurrence. Only 12% of patients with atrial&#xD;
      fibrillation were receiving anticoagulant treatment prior to recurrence. In multivariate&#xD;
      analysis, recurrence was more frequently associated with a history of transient ischemic&#xD;
      attack (TIA), atrial fibrillation, male gender, and hypertension, but not with age, daily&#xD;
      alcohol consumption, smoking, diabetes, ischemic heart disease, serum cholesterol or&#xD;
      hematocrit. Mortality was almost doubled compared with patients with a first-ever stroke. In&#xD;
      survivors, however, both neurologic and functional outcomes and the speed of recovery were,&#xD;
      in general, similar in the two groups. Despite similar neurologic impairments, patients with&#xD;
      recurrence contralateral to their first stroke had markedly more severe functional disability&#xD;
      after completed rehabilitation than patients with ipsilateral recurrence, implying that the&#xD;
      ability to compensate functionally is decreased in patients with contralateral recurrence.&#xD;
&#xD;
      However, recently the rates of stroke recurrence have changed in developed countries. On&#xD;
      average, the annual risk for future ischemic stroke after an initial ischemic stroke or TIA&#xD;
      is ≈3% to 4%. Recent clinical trials of patients with non-cardio embolic ischemic stroke&#xD;
      suggest the risk may be as low as 3%, but these data probably underestimate the&#xD;
      community-based rate. The estimated risk for an individual patient will be affected by&#xD;
      specific characteristics of the event and the person, including age, event type, comorbid&#xD;
      illness, and adherence to preventive therapy. The current average annual rate of future&#xD;
      stroke (≈3%-4%) represents a historical low that is the result of important discoveries in&#xD;
      prevention science. These include antiplatelet therapy and effective strategies for the&#xD;
      treatment of hypertension, atrial fibrillation, arterial obstruction and hyperlipidemia.&#xD;
&#xD;
      Even in developed nations currently, there are large gaps in the utilization of preventive&#xD;
      drugs, control of risk factors, and uptake of lifestyle-changing behaviours. This is often&#xD;
      because of failure in the initiation of secondary prevention.&#xD;
&#xD;
      Novel methods to improve the risk factor control to prevent recurrent stroke&#xD;
&#xD;
      In 2017, the number of mobile phone users is forecast to reach 4.77 billion. The number of&#xD;
      mobile phone users in the world is expected to pass the five billion mark by 2019. In 2014,&#xD;
      nearly 60 per cent of the population worldwide already owned a mobile phone. Mobile phone&#xD;
      text messages can be used to remind, encourage, and motivate patients to adhere to secondary&#xD;
      prevention strategies, but there has been limited robust scientific evaluation of these&#xD;
      interventions.&#xD;
&#xD;
      Recurrent stroke in India&#xD;
&#xD;
      Data on recurrent stroke and its causes are scarce from low and middle-income countries like&#xD;
      India. In the door-to-door survey done in Kolkata, 15% of patients had a recurrent stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 28, 2018</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study is a multicenter, randomized, parallel-design, adaptive and blinded end-point clinical trial of sub-acute stroke patients</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded end-point clinical trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular event</measure>
    <time_frame>One year.</time_frame>
    <description>Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure (mmHg)</measure>
    <time_frame>One year.</time_frame>
    <description>SBP is independent secondary outcome measure. Systolic Blood pressure will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood Glucose (mg/dl)</measure>
    <time_frame>One year.</time_frame>
    <description>Fasting Blood Glucose will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome. Limit 30-1000. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL Cholesterol (mg/dl)</measure>
    <time_frame>One year.</time_frame>
    <description>LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides (mg/dl)</measure>
    <time_frame>One year.</time_frame>
    <description>Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking cessation (No/ total %)</measure>
    <time_frame>One year.</time_frame>
    <description>Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol cessation</measure>
    <time_frame>One year.</time_frame>
    <description>Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (kg/m2)</measure>
    <time_frame>One year.</time_frame>
    <description>Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity MET (min/week)</measure>
    <time_frame>One year.</time_frame>
    <description>Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Non-Compliance Assessment (INCA)</measure>
    <time_frame>One year.</time_frame>
    <description>Intervention Non-Compliance Assessment (INCA) will be assessed at baseline and one year.&#xD;
This measures is to note the adherence to the medication for the baseline to one year follow-up. The assessment is not score based. the question: &quot;Have you missed your medication ever?&quot;, the more the patients mark NO will have the better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale (mRS)</measure>
    <time_frame>One year.</time_frame>
    <description>Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure (mmHg)</measure>
    <time_frame>One year.</time_frame>
    <description>Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">5830</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Structured Semi-Interactive Prevention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard post stroke care for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured Semi-Interactive Stroke Prevention Package</intervention_name>
    <description>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.</description>
    <arm_group_label>Structured Semi-Interactive Prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years and above including both men and women&#xD;
&#xD;
          2. First-ever Ischemic stroke or intracerebral haemorrhage&#xD;
&#xD;
          3. Between 2 days-3 months of stroke symptom onset&#xD;
&#xD;
          4. Computed Tomography /Magnetic Resonance Imaging shows recent stroke (infarct and/or&#xD;
             hemorrhage)&#xD;
&#xD;
          5. Able to read and complete simple tasks suggested in the stroke workbook if having&#xD;
             aphasia or is illiterate, a caregiver is available to read for the patients and&#xD;
             complete the reading/workbook tasks for the patients.&#xD;
&#xD;
          6. Able to read and possess a working personal mobile cellular device. In case of&#xD;
             patients who is not able to read and/or don't have a personal mobile cellular device&#xD;
             or unable to use it, a caregiver is available all times who is able to use mobile&#xD;
             cellular devices and read to the patient.&#xD;
&#xD;
          7. Able to watch health education videos on a video player on cellular device or any&#xD;
             other video player available to the patient.&#xD;
&#xD;
          8. Able to come for follow up visits for at least 1 year&#xD;
&#xD;
          9. Able to provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Modified Rankin scale score 0 and 1 at the time of enrollment&#xD;
&#xD;
          2. Limited internet and/or mobile accessibility due to travel&#xD;
&#xD;
          3. Patients having active malignancies needing intensive therapy&#xD;
&#xD;
          4. Patients with a terminal illness with an anticipated lifespan of less than 1 year&#xD;
&#xD;
          5. Patients with heart failure admitted more than twice in the last six months&#xD;
&#xD;
          6. Patients with current psychiatric illness with loss of insight and suicide attempts&#xD;
&#xD;
          7. Patients with cerebral venous sinus thrombosis, aneurysmal subarachnoid haemorrhage,&#xD;
             isolated central nervous system vasculitis and systemic vasculitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeyaraj D Pandian, MD DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christian Medical College and Hospital, Ludhiana, India</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeyaraj D Pandian, MD DM</last_name>
    <phone>9915784750</phone>
    <email>jeyarajpandian@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Christian Medical College and Hospital</name>
      <address>
        <city>Ludhiana</city>
        <state>Punjab</state>
        <zip>141008</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeyaraj D Pandian, MD DM</last_name>
      <phone>9915784750</phone>
      <email>jeyarajpandian@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Jeyaraj D Pandian, MD DM FRACP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>22267690</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26486857</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 3, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Christian Medical College and Hospital, Ludhiana, India</investigator_affiliation>
    <investigator_full_name>Jeyaraj D Pandian</investigator_full_name>
    <investigator_title>Principal and Professor, Department of Neurology</investigator_title>
  </responsible_party>
  <keyword>Secondary Prevention Package</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>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.&#xD;
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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228979
org study id: SPRINT INDIA
nct id: NCT03228979
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Stroke is the second leading cause of death worldwide in 2010. In rural Maharashtra, it is
      the leading cause of death. The Stroke incidence in India ranges from 135 to 145 per 100,000
      population. From the recent Ludhiana population-based Stroke Registry and also from the
      INSPIRE Registry 25% of the patients are below 49 years of age. Hypertension, smoking,
      alcohol, diabetes, heart disease and lifestyle-related problems are the common causes of
      stroke in India. Rheumatic heart disease and cerebral venous thrombosis are the main
      etiologies of stroke in the young in our country.

      Recurrent stroke

      In an Oxfordshire Community Stroke Project reported in 1994, it was found that actuarial risk
      of suffering a recurrence was 30% (95% confidence interval, 20% to 39%) by 5 years, about
      nine times the risk of stroke in the general population. The risk was highest early after the
      first stroke: 13% (95% confidence interval, 10% to 16%) by 1 year, 15 times the risk in the
      general population. After the first year, the average annual risk was about 4%.

      In the Copenhagen Stroke Study, stroke was recurrent in 23% despite most of these patients
      being given prophylactic treatment prior to recurrence. Only 12% of patients with atrial
      fibrillation were receiving anticoagulant treatment prior to recurrence. In multivariate
      analysis, recurrence was more frequently associated with a history of transient ischemic
      attack (TIA), atrial fibrillation, male gender, and hypertension, but not with age, daily
      alcohol consumption, smoking, diabetes, ischemic heart disease, serum cholesterol or
      hematocrit. Mortality was almost doubled compared with patients with a first-ever stroke. In
      survivors, however, both neurologic and functional outcomes and the speed of recovery were,
      in general, similar in the two groups. Despite similar neurologic impairments, patients with
      recurrence contralateral to their first stroke had markedly more severe functional disability
      after completed rehabilitation than patients with ipsilateral recurrence, implying that the
      ability to compensate functionally is decreased in patients with contralateral recurrence.

      However, recently the rates of stroke recurrence have changed in developed countries. On
      average, the annual risk for future ischemic stroke after an initial ischemic stroke or TIA
      is ≈3% to 4%. Recent clinical trials of patients with non-cardio embolic ischemic stroke
      suggest the risk may be as low as 3%, but these data probably underestimate the
      community-based rate. The estimated risk for an individual patient will be affected by
      specific characteristics of the event and the person, including age, event type, comorbid
      illness, and adherence to preventive therapy. The current average annual rate of future
      stroke (≈3%-4%) represents a historical low that is the result of important discoveries in
      prevention science. These include antiplatelet therapy and effective strategies for the
      treatment of hypertension, atrial fibrillation, arterial obstruction and hyperlipidemia.

      Even in developed nations currently, there are large gaps in the utilization of preventive
      drugs, control of risk factors, and uptake of lifestyle-changing behaviours. This is often
      because of failure in the initiation of secondary prevention.

      Novel methods to improve the risk factor control to prevent recurrent stroke

      In 2017, the number of mobile phone users is forecast to reach 4.77 billion. The number of
      mobile phone users in the world is expected to pass the five billion mark by 2019. In 2014,
      nearly 60 per cent of the population worldwide already owned a mobile phone. Mobile phone
      text messages can be used to remind, encourage, and motivate patients to adhere to secondary
      prevention strategies, but there has been limited robust scientific evaluation of these
      interventions.

      Recurrent stroke in India

      Data on recurrent stroke and its causes are scarce from low and middle-income countries like
      India. In the door-to-door survey done in Kolkata, 15% of patients had a recurrent stroke.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study is a multicenter, randomized, parallel-design, adaptive and blinded end-point clinical trial of sub-acute stroke patients
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Blinded end-point clinical trial
measure: Cardiovascular event
time frame: One year.
description: Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.
measure: Systolic Blood Pressure (mmHg)
time frame: One year.
description: SBP is independent secondary outcome measure. Systolic Blood pressure will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome.
measure: Fasting Blood Glucose (mg/dl)
time frame: One year.
description: Fasting Blood Glucose will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome. Limit 30-1000. Lower score, better outcome.
measure: LDL Cholesterol (mg/dl)
time frame: One year.
description: LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.
measure: Triglycerides (mg/dl)
time frame: One year.
description: Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.
measure: Smoking cessation (No/ total %)
time frame: One year.
description: Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.
measure: Alcohol cessation
time frame: One year.
description: Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.
measure: Body Mass Index (kg/m2)
time frame: One year.
description: Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.
measure: Physical Activity MET (min/week)
time frame: One year.
description: Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.
measure: Intervention Non-Compliance Assessment (INCA)
time frame: One year.
description: Intervention Non-Compliance Assessment (INCA) will be assessed at baseline and one year.
This measures is to note the adherence to the medication for the baseline to one year follow-up. The assessment is not score based. the question: "Have you missed your medication ever?", the more the patients mark NO will have the better outcome.
measure: Modified Rankin Scale (mRS)
time frame: One year.
description: Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.
measure: Diastolic Blood Pressure (mmHg)
time frame: One year.
description: Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.
arm group label: Structured Semi-Interactive Prevention
arm group type: Active Comparator
description: 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
arm group label: Control group
arm group type: No Intervention
description: Patients will receive standard post stroke care for 1 year
intervention type: Other
intervention name: Structured Semi-Interactive Stroke Prevention Package
description: 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.
arm group label: Structured Semi-Interactive Prevention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jeyaraj D Pandian, MD DM
role: Principal Investigator
affiliation: Christian Medical College and Hospital, Ludhiana, India
last name: Jeyaraj D Pandian, MD DM
phone: 9915784750
email: jeyarajpandian@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: India
citation: 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: 22267690
citation: 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: 26486857
responsible party type: Principal Investigator
investigator affiliation: Christian Medical College and Hospital, Ludhiana, India
investigator full name: Jeyaraj D Pandian
investigator title: Principal and Professor, Department of Neurology
mesh term: Stroke
sharing ipd: No
ipd description: 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.