Clinical trial NCT04316286: TElemedicine for NARcolepsy
Official title: Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: University of Bologna
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: IRCCS Istituto delle Scienze Neurologiche di Bologna
First posted: 2020-03-20
Enrollment: 202
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: excessive daytime sleepiness
timeFrame: 12 months
Secondary outcomes:
measure: metabolic control - weight Changes
timeFrame: 12 months
measure: metabolic control - lipid profile Changes
timeFrame: 12 months
measure: metabolic control - glycemic profile Changes
timeFrame: 12 months
measure: metabolic control - caloric intake Changes
timeFrame: 12 months
measure: metabolic control - physical activity Changes
timeFrame: 12 months
measure: quality of life - Short-Form 36-Item Questionnaire
timeFrame: 12 months
measure: quality of life - Pediatric Quality of Life Inventory
timeFrame: 12 months
measure: patient and family satisfaction with care
timeFrame: 12 months
measure: safety
timeFrame: 12 months
measure: costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs - Istituto Delle Scienze Neurologiche
Study officials:
affiliation: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: Giuseppe Plazzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingravallo F, Vignatelli L, Pagotto U, Vandi S, Moresco M, Mangiaruga A, Oriolo C, Zenesini C, Pizza F, Plazzi G. Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR). BMC Neurol. 2020 May 11;20(1):176. doi: 10.1186/s12883-020-01762-9.