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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
202
Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists
Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists
Irccs - Istituto Delle Scienze Neurologiche
Bologna, Italy
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
Time frame: 12 months
metabolic control - weight Changes
metabolic control - weight Changes of weight in kilograms. \[Time frame: 12 months\]
Time frame: 12 months
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). \[Time frame: 12 months\]
Time frame: 12 months
metabolic control - glycemic profile Changes
metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). \[Time frame: 12 months\]
Time frame: 12 months
metabolic control - caloric intake Changes
metabolic control - caloric intake Changes of caloric intake measured by a food diary. \[Time frame: 12 months\]
Time frame: 12 months
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. \[Time frame: 12 months\]
Time frame: 12 months
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. \[Time frame: 12 months\]
Time frame: 12 months
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. \[Time frame: 12 months\]
Time frame: 12 months
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.
Time frame: 12 months
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).
Time frame: 12 months
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).
Time frame: 12 months
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