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

2021년 7월 26일 업데이트: Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

5830

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Punjab
      • Ludhiana, Punjab, 인도, 141008
        • 모병
        • Christian Medical College and Hospital
        • 연락하다:
        • 수석 연구원:
          • Jeyaraj D Pandian, MD DM FRACP

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
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.
간섭 없음: Control group
Patients will receive standard post stroke care for 1 year

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cardiovascular event
기간: One year.
Primary outcome measure is a composite endpoint of Recurrent Stroke, high-risk Transient Ischemic Attack, Acute Coronary Syndrome and Death.
One year.

2차 결과 측정

결과 측정
측정값 설명
기간
Systolic Blood Pressure (mmHg)
기간: 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.
One year.
Fasting Blood Glucose (mg/dl)
기간: 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.
One year.
LDL Cholesterol (mg/dl)
기간: One year.
LDL Cholesterol will be assessed at baseline and one year. Limit 30-1000. Lower score, better outcome.
One year.
Triglycerides (mg/dl)
기간: One year.
Triglycerides will be assessed at baseline and one year. Limit 30-1500. Lower score, better outcome.
One year.
Smoking cessation (No/ total %)
기간: One year.
Smoking cessation will be assessed at baseline and one year. Cessation of smoking at 1 year means better outcome.
One year.
Alcohol cessation
기간: One year.
Alcohol cessation will be assessed at baseline and one year. Cessation of alcohol at 1 year means better outcome.
One year.
Body Mass Index (kg/m2)
기간: One year.
Body Mass Index will be assessed at baseline and one year. Limit 15-50. Lower score, better outcome.
One year.
Physical Activity MET (min/week)
기간: One year.
Physical Activity MET (Metabolic Equivalent of Task) will be assessed at baseline and one year. Limit 0-40000. Higher score better outcome.
One year.
Intervention Non-Compliance Assessment (INCA)
기간: 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.

One year.
Modified Rankin Scale (mRS)
기간: One year.
Modified Rankin Scale will be assessed at baseline and one year. Limit 0-5. Lower score, better outcome.
One year.
Diastolic Blood Pressure (mmHg)
기간: One year.
Diastolic Blood pressure will be assessed at baseline and one year. Limit 60-140. A lower score, better outcome.
One year.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jeyaraj D Pandian, MD DM, Christian Medical College and Hospital, Ludhiana, India

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 4월 28일

기본 완료 (예상)

2022년 3월 30일

연구 완료 (예상)

2022년 3월 30일

연구 등록 날짜

최초 제출

2017년 2월 3일

QC 기준을 충족하는 최초 제출

2017년 7월 22일

처음 게시됨 (실제)

2017년 7월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 26일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
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