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临床试验/CTRI/2024/02/062352
CTRI/2024/02/062352尚未招募4 期

Tele-school health led Epilepsy Smart Schools in India: An Implementation Initiative with Mixed Methods Assessment (Tele_ESSI).

Director General , Indian Council of Medical Research5 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年2月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
600
试验地点
5
主要终点
1. Health Outcomes :

研究概览

简要总结

Study design: Mixed methods before- after quasi-experimental study.

The research protocol will be undertaken in two stages:

Stage 1 with an observational design to estimate the occurrence and incidence of epileptic seizures during school hours through tele-school health initiatives in three nationwide districts.

Stage 2 with a hybrid interventional-implementation design comprising a school-based, before-after quasi-experimental study of Tele-school health-led Epilepsy Smart Schools in India (Tele_ESSI) Model to improve coverage and management of epilepsy in the schools in three nationwide districts.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
24.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • School children of India in government schools.

排除标准

  • School children of India not studying in government schools.

结局指标

主要结局

1. Health Outcomes :

时间窗: 12 months after the intervention

i. Occurrence and incidence of epileptic seizures during school hours.

时间窗: 12 months after the intervention

ii. Seizure Control and Quality of Life

时间窗: 12 months after the intervention

iii. Number of Injuries and accidents related to seizures.

时间窗: 12 months after the intervention

iv. Improved management of comorbidities

时间窗: 12 months after the intervention

2. Education-related

时间窗: 12 months after the intervention

i. Scholastic Performance of children with epilepsy in schools.

时间窗: 12 months after the intervention

ii. School dropout rate.

时间窗: 12 months after the intervention

3. Acceptability

时间窗: 12 months after the intervention

i. Improvement in Knowledge, Attitude and Practices of stakeholders.

时间窗: 12 months after the intervention

ii. Cost-effectiveness of the intervention model.

时间窗: 12 months after the intervention

次要结局

  • 1. To document the occurrence and incidence of epileptic seizures during school hours.(2. To assess the feasibility, acceptability and adoptability of the school-based tele-intervention among school personnel, primary health care providers and parents of children with epilepsy.)

研究者

发起方
Director General , Indian Council of Medical Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Sulena

Guru Gobind Singh Medical College and Hospital

研究点 (5)

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