An interventional study of Structured Semi-Interactive Stroke Prevention Package in Stroke, sponsored by Christian Medical College and Hospital, Ludhiana, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Christian Medical College and Hospital, Ludhiana, India · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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
Patients will receive standard post stroke care for 1 year
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.
Cardiovascular event
Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.
Time frame: One year.
Systolic Blood Pressure (mmHg)
SBP is independent secondary outcome measure. Systolic Blood pressure will be assessed at baseline and one year. Limit 90-250. Lower score, better outcome.
Time frame: One year.
Fasting Blood Glucose (mg/dl)
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.
Time frame: One year.
LDL Cholesterol (mg/dl)
LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.
Time frame: One year.
Triglycerides (mg/dl)
Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.
Time frame: One year.
Smoking cessation (No/ total %)
Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.
Time frame: One year.
Alcohol cessation
Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.
Time frame: One year.
Body Mass Index (kg/m2)
Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.
Time frame: One year.
Physical Activity MET (min/week)
Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.
Time frame: One year.
Intervention Non-Compliance Assessment (INCA)
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.
Time frame: One year.
Modified Rankin Scale (mRS)
Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.
Time frame: One year.
Diastolic Blood Pressure (mmHg)
Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.
Time frame: One year.
Plan to share: No — 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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Christian Medical College and Hospital, Ludhiana, India