Comparison of telemedicine versus in-person follow-Up in children with infantile epileptic spasms syndrome (IESS): A Randomized controlled trial (Tele-IESS Trial)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indian Council of Medical Research (ICMR)
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 2.00 Month(s) to 24.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Prior history of ACTH or steroid therapy for epilepsy.
- •Structural brain abnormalities requiring urgent neurosurgical intervention.
Outcomes
Primary Outcomes
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.
Time Frame: Outcomes measured at 1, 2, and 6 weeks
Secondary Outcomes
- 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)
Investigators
Jitendra Kumar Sahu
Postgraduate Institute of Medical Education and Research, Chandigarh