NCT04316286

TElemedicine for NARcolepsy

Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy. Open RCT assessing the non-inferiority of the multidisciplinary management of narcolepsy via Video Consultation (VC) through Mobile Telemedicine devices compared to usual in-office care. 202 children and adults with narcolepsy will be randomly allocated in 1:1 ratio to VC or in-office usual care for a 12 months follow-up. At baseline, all patients will undergo a neurologic, metabolic, and psychosocial assessment. Primary (i.e., excessive daytime sleepiness according to the Epworth Sleepiness Scale) and secondary endpoints (i.e., other symptoms, metabolic control, quality of life, patient and family satisfaction with care, feasibility, safety, and costs) will be measured at 6 and 12 months. The investigators expect the Telemedicine approach not only to be non-inferior for sleepiness control but also to significantly improve other patient-centred outcomes compared to the usual in-office care.

Conditions

• Narcolepsy

Interventions

Type	Name	Description
PROCEDURE	Tele-multidisciplinary care	Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists
OTHER	Standard care	Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-11-24
• Completion: 2023-05-31
• First posted: 2020-03-20
• Last updated: 2023-06-07

Locations

1 site across 1 country: Italy