Clinical trial NCT03228979: Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study
Official title: Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Secondary Prevention Package
Education
Lead sponsor: Christian Medical College and Hospital, Ludhiana, India
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2017-07-25
Enrollment: 5830
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Cardiovascular event
timeFrame: One year.
Secondary outcomes:
measure: Systolic Blood Pressure (mmHg)
timeFrame: One year.
measure: Fasting Blood Glucose (mg/dl)
timeFrame: One year.
measure: LDL Cholesterol (mg/dl)
timeFrame: One year.
measure: Triglycerides (mg/dl)
timeFrame: One year.
measure: Smoking cessation (No/ total %)
timeFrame: One year.
measure: Alcohol cessation
timeFrame: One year.
measure: Body Mass Index (kg/m2)
timeFrame: One year.
measure: Physical Activity MET (min/week)
timeFrame: One year.
measure: Intervention Non-Compliance Assessment (INCA)
timeFrame: One year.
measure: Modified Rankin Scale (mRS)
timeFrame: One year.
measure: Diastolic Blood Pressure (mmHg)
timeFrame: One year.
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
Study officials:
affiliation: Christian Medical College and Hospital, Ludhiana, India
name: Jeyaraj D Pandian, MD DM
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.
citation: 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.