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Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study (SPRINT)

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ClinicalTrials.gov Identifier: NCT03228979
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India

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.


Condition or disease Intervention/treatment Phase
Stroke Other: Structured Semi-Interactive Stroke Prevention Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5830 participants
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
Masking: Single (Outcomes Assessor)
Masking Description: Blinded end-point clinical trial
Primary Purpose: Prevention
Official Title: Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study
Actual Study Start Date : April 28, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Arm Intervention/treatment
Active Comparator: Structured Semi-Interactive Prevention
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
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.

No Intervention: Control group
Patients will receive standard post stroke care for 1 year



Primary Outcome Measures :
  1. Cardiovascular event [ Time Frame: One year. ]
    Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.


Secondary Outcome Measures :
  1. Systolic Blood Pressure (mmHg) [ Time Frame: One year. ]
    SBP is independent secondary outcome measure. Systolic Blood pressure will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome.

  2. Fasting Blood Glucose (mg/dl) [ Time Frame: One year. ]
    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.

  3. LDL Cholesterol (mg/dl) [ Time Frame: One year. ]
    LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.

  4. Triglycerides (mg/dl) [ Time Frame: One year. ]
    Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.

  5. Smoking cessation (No/ total %) [ Time Frame: One year. ]
    Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.

  6. Alcohol cessation [ Time Frame: One year. ]
    Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.

  7. Body Mass Index (kg/m2) [ Time Frame: One year. ]
    Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.

  8. Physical Activity MET (min/week) [ Time Frame: One year. ]
    Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.

  9. Intervention Non-Compliance Assessment (INCA) [ Time Frame: One year. ]

    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.


  10. Modified Rankin Scale (mRS) [ Time Frame: One year. ]
    Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.

  11. Diastolic Blood Pressure (mmHg) [ Time Frame: One year. ]
    Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and above including both men and women
  2. First-ever Ischemic stroke or intracerebral haemorrhage
  3. Between 2 days-3 months of stroke symptom onset
  4. Computed Tomography /Magnetic Resonance Imaging shows recent stroke (infarct and/or hemorrhage)
  5. 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.
  6. 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.
  7. Able to watch health education videos on a video player on cellular device or any other video player available to the patient.
  8. Able to come for follow up visits for at least 1 year
  9. Able to provide signed informed consent.

Exclusion Criteria:

  1. Modified Rankin scale score 0 and 1 at the time of enrollment
  2. Limited internet and/or mobile accessibility due to travel
  3. Patients having active malignancies needing intensive therapy
  4. Patients with a terminal illness with an anticipated lifespan of less than 1 year
  5. Patients with heart failure admitted more than twice in the 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 haemorrhage, isolated central nervous system vasculitis and systemic vasculitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228979


Contacts
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Contact: Jeyaraj D Pandian, MD DM 9915784750 jeyarajpandian@hotmail.com

Locations
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India
Christian Medical College and Hospital Recruiting
Ludhiana, Punjab, India, 141008
Contact: Jeyaraj D Pandian, MD DM    9915784750    jeyarajpandian@hotmail.com   
Principal Investigator: Jeyaraj D Pandian, MD DM FRACP         
Sponsors and Collaborators
Christian Medical College and Hospital, Ludhiana, India
Indian Council of Medical Research
Investigators
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Principal Investigator: Jeyaraj D Pandian, MD DM Christian Medical College and Hospital, Ludhiana, India
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeyaraj D Pandian, Principal and Professor, Department of Neurology, Christian Medical College and Hospital, Ludhiana, India
ClinicalTrials.gov Identifier: NCT03228979    
Other Study ID Numbers: SPRINT INDIA
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India:
Secondary Prevention Package
Education
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases