TElemedicine for NARcolepsy

Narcolepsy Clinical Trial

— TENAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316286
• Other study ID #: RF-2016-02364742
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Azienda Usl di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 31, 2023
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Narcolepsy

Intervention

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

Locations

Country	Name	City	State
Italy	Irccs - Istituto Delle Scienze Neurologiche	Bologna

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Usl di Bologna	IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS-Istituto delle scienze neurologiche di Bologna, University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	excessive daytime sleepiness	Measured by the Epworth Sleepiness Scale. The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score). The proposed range for normal subjects is 0-10	12 months
Secondary	metabolic control - weight Changes	metabolic control - weight Changes of weight in kilograms. [Time frame: 12 months]	12 months
Secondary	metabolic control - lipid profile Changes	metabolic control - lipid profile Changes of: total cholesterol; high-density lipoprotein cholesterol; low-density lipoprotein cholesterol; total triglycerides. All are measured in milligrams per deciliter (mg/dl).; [Time frame: 12 months]	12 months
Secondary	metabolic control - glycemic profile Changes	metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). [Time frame: 12 months]	12 months
Secondary	metabolic control - caloric intake Changes	metabolic control - caloric intake Changes of caloric intake measured by a food diary. [Time frame: 12 months]	12 months
Secondary	metabolic control - physical activity Changes	metabolic control - physical activity Changes of physical activity measured by the International Physical Activity Questionnaire (IPAQ). Total physical activity is measured in MET-min/week and time spent sitting, and it is ranked in three levels: low; moderate; high.; [Time frame: 12 months]	12 months
Secondary	quality of life - Short-Form 36-Item Questionnaire	Quality of life - Short-Form 36-Item Questionnaire (SF-36) Changes of SF-36 health related quality of life (HRQOL) scales. This tool presents 36 questions. Eight health domains are assessed (physical activities; social activities; limitations in role activities because of physical health problems; bodily pain; mental health; limitations in role activities because of emotional problems; vitality; general health perceptions). Each domain measures a level of HRQOL with a scale between 0-100, with 0 being bad quality of life and 100 being good.; [Time frame: 12 months]	12 months
Secondary	quality of life - Pediatric Quality of Life Inventory	Quality of life - Pediatric Quality of Life Inventory (PedsQL) Changes of PedsQL health related quality of life (HRQOL) scales. This is a tool of 23 questions comprising four generic domains: physical functioning; emotional functioning; social functioning; school functioning. These domains are measured by a 0-100 scale. Higher scores indicate better HRQOL.; [Time frame: 12 months]	12 months
Secondary	patient and family satisfaction with care	patient and family satisfaction with care, measured by an ad-hoc devised form (named Co-Tenar), assessing qualitatively the satisfaction level.	12 months
Secondary	safety	safety, in terms of number (percent) of full drop-outs, partial drop-outs (patients changing procedure), adverse reactions to drugs in both group of intervention (standard in-office visit arm, video-consultation arm).	12 months
Secondary	costs	costs related to the disease management (drugs, tests, hospitalization, journeys) will be assessed, by means of a standardized interview, in both group of intervention (standard in-office visit arm, video-consultation arm).	12 months