TElemedicine for NARcolepsy (TENAR)

Azienda Usl di Bologna

Status: Completed

Conditions: Narcolepsy

Treatments: Other: Standard care; Procedure: Tele-multidisciplinary care

Study type: Interventional

Funder types: Other

Identifiers

NCT04316286

RF-2016-02364742

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents (≥14 years old) and adults with a diagnosis of narcolepsy according to ICSD-3 criteria at their first ("incident") or with established diagnosis ("prevalent" subjects), able to provide consent

Exclusion criteria

• inability to read, write, or using a tablet;
• major psychiatric disorders.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Tele-multidisciplinary participants

Experimental group

Description:

Patients undergoing televisit

Treatment:

Procedure: Tele-multidisciplinary care

In-office standard participants

Other group

Description:

Patients undergoing in-office visits

Treatment:

Other: Standard care