Comparison of telemedicine versus in-person follow-Up in children with infantile epileptic spasms syndrome (IESS): A Randomized controlled trial (Tele-IESS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Epileptic spasms-free rate, as reported by parents at 1, 2, and 6 weeks and validated by EEG resolution using BASED scoring at 6 weeks post-treatment.
研究概览
简要总结
Telemedicine is an increasingly feasible alternative to in-person care for chronic conditions like epilepsy, especially in settings where distance limits access. However, its use in Infantile Epileptic Spasms Syndrome (IESS) is challenging because patients require daily injectable hormonal therapy, frequent monitoring, and EEG assessments. Timely treatment is crucial for neurodevelopment, but in low- and middle-income countries, access is often limited by a scarcity of child neurologists and travel burdens, resulting in high loss-to-follow-up. This proof-of-concept, randomized controlled study evaluates the feasibility of telemedicine-based follow-up in IESS and directly compares its efficacy, safety, cost-effectiveness, and impact on quality of life to standard in-person follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of IESS as per ILAE
- •Newly started on ACTH therapy.
- •Parents or caregivers willing to participate and provide informed consent.
- •Access to a smartphone/internet
- •Resides more than 10km distance from our institute.
排除标准
- •Prior history of ACTH or steroid therapy for epilepsy.
- •Structural brain abnormalities requiring urgent neurosurgical intervention.
结局指标
主要结局
Epileptic spasms-free rate, as reported by parents at 1, 2, and 6 weeks and validated by EEG resolution using BASED scoring at 6 weeks post-treatment.
时间窗: Outcomes measured at 1, 2, and 6 weeks
次要结局
- To assess caregiver burden (Zarit Burden Interview) and parental QoL (EQ-5D-5L) at 2- and 6-weeks post-treatment, comparing TMF and IPF groups.(Zarit Burden Interview scores at baseline, 2 and 6 weeks post-treatment and parental QoL at baseline and 6 weeks)
- To measure adherence to ACTH therapy using MARS-5 at 6 weeks post-treatment for both groups.(At six weeks)
- To analyze telemedicine follow-up cost-effectiveness versus in-person follow-up by assessing direct/indirect costs and identifying implementation barriers through qualitative interviews at study completion.(Assessed over completion of 6 weeks)
研究者
Jitendra Kumar Sahu
Postgraduate Institute of Medical Education and Research, Chandigarh