Impact of virtual interactive epilepsy education versus digital educational material in people with epilepsy and their caregivers: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Knowledge regarding epilepsy including first aid management of seizures and medication compliance as assessed by a self developed structured questionnaire
研究概览
简要总结
A study to assess the impact of virtual interactive epilepsy education in people with epilepsy and their caregivers is undertaken by the researcher which is a randomized controlled trial.
Participants will be randomly assigned either to the control arm (receiving digital educational material) or the experimental arm (receiving digital educational material plus virtual interactive epilepsy education). A pre- test will be taken before the intervention by a self- developed structured questionnaire, virtually, either in google forms format or telephonically. The control group will then receive digital educational material and they will be requested to go through it. In the intervention arm, participants will be receiving digital educational material and a 10 minutes session on information regarding epilepsy through a video call or telephonically which will be delivered by the researcher.
The participants will also be taught how to maintain a seizure diary. Post- test will be taken after the intervention in both the groups with the help of self-developed structured questionnaire, virtually, either in google forms format or telephonically. After 15 days, a telephonic reinforcement will be given regarding maintaining the seizure diary and to ask for any problems encountered during this period. A one month follow up, telephonically, will be done focussing on breakthrough seizures and quality of life which will be assessed with the help of seizure diary and quality of life scale (QOLIE-31). The comparison between the two interventions will be done to see the impact that each intervention is having.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •People with epilepsy (PWE) who have been in the follow-up for at least 6 months PWE aged more than 18 years.
- •Caregivers who are staying with PWE for at least 1 month and are directly involved in care.
- •Smart phone users Able to understand Hindi or English.
排除标准
- •Not using smart phones Unwilling to participate.
结局指标
主要结局
Knowledge regarding epilepsy including first aid management of seizures and medication compliance as assessed by a self developed structured questionnaire
时间窗: Pre intervention, immediate post intervention
次要结局
- Breakthrough seizures(Quality of life)