Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
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
- 2
- 主要终点
- Evaluation of improvement in quality of life after receiving an intervention module.
研究概览
简要总结
Patients with epilepsy, especially drug-resistant epilepsy, have a lot of cognitive & psycho-social issues. There is little evidence pertaining to the efficacy of the various cognitive-behavioral interventions and cognitive retraining modules used in epilepsy patients in the Indian context. The real value of these interventions needs further consolidation in terms of its assessment and efficacy. The available literature is scanned and having limitations in terms of assessment tool used, sample size, and also lacks a broader spectrum of psychosocial interventions used. In view of the above limitations, we plan to specially develop & test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions. This module will help in planning the future needs of epileptic patients in terms of not only medication but also guide us in choosing the kind of interventions to be used with a particular patient or group of patients.
详细描述
We plan to specially develop & test a Neuro-cognitive and psychosocial intervention module, based on the deficits found in these domains that will help DRE patients to improve their quality of life. This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions.
AIM To develop and test the efficacy of Neuro-cognitive and psychosocial intervention module in drug-resistant epilepsy.
Clinical Sample: The sample will consist of patients with Drug-resistant epilepsy (DRE). Patients with Drug-resistant epilepsy (DRE) will be included per inclusion and exclusion criteria. The subjects will be taken from the patients attending Refractory epilepsy clinic (REC), Department of Neurology, PGIMER, Chandigarh.
Informed written consent will be obtained from all the study participants per the rules and regulations of the Institutional Ethics Committee of PGIMER.
Study design: It will be a pre and post-design. Subjects fulfilling the inclusion and exclusion criteria will be randomly assigned to intervention and control groups-a Hospital-based Randomized Control Trial Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Stat Trek software will be adopted to randomize the patients. It is a computer-generated randomization technique. Numbering of the groups has been decided based on coin-flipping.
- Intervention group
- Control group
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of 18 - 45 years of age.
- •either gender
- •Willing to participate and sign the informed consent
排除标准
- •Patients with other neurological disorders
- •any other trial at inclusion
- •should not have any major psychiatric disorder
- •pregnant and lactating mothers
- •also, patients who would not be giving informed consent
- •Patients with intellectual disabilities.
结局指标
主要结局
Evaluation of improvement in quality of life after receiving an intervention module.
时间窗: 2 -3 years
Quality of life in epilepsy-31 scale was used to assess quality of life. The scores are usually transformed into a 0-100 scale, with higher scores indicating a better quality of life.
次要结局
- Evaluation of depression in drug-resistant epilepsy patients after receiving an intervention module.(2 -3 years)
- Evaluation of stigma in drug-resistant epilepsy patients after receiving an intervention module.(2 -3 years)
- Evaluation of Disability in drug-resistant epilepsy patients after receiving an intervention module.(2 -3 years)
- Evaluation of improvement in memory among patients with drug-resistant epilepsy after receiving an intervention module.(2 -3 years)
- Evaluation of improvement in executive functioning among patients with drug-resistant epilepsy after receiving an intervention module.(2 -3 years)
- Evaluation of anxiety in drug-resistant epilepsy patients after receiving an intervention module.(2 -3 years)
- Evaluation of improvement in attention among patients with drug-resistant epilepsy after receiving an intervention module.(2 -3 years)
研究者
Neetu Choudhary
Principal Investigator
Post Graduate Institute of Medical Education and Research, Chandigarh