TElemedicine for NARcolepsy

Not Applicable

Completed

• Conditions: Narcolepsy
• Interventions: Other: Standard care; Procedure: Tele-multidisciplinary care

• Registration Number: NCT04316286
• Lead Sponsor: Azienda Usl di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Study Start: 2020-04-01
• Primary Completion: 2022-11-24
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-office standard participants	Standard care	Patients undergoing in-office visits
Tele-multidisciplinary participants	Tele-multidisciplinary care	Patients undergoing televisit

Primary Outcome Measures

Name	Time	Method
excessive daytime sleepiness	12 months	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

Secondary Outcome Measures

Name	Time	Method
metabolic control - glycemic profile Changes	12 months	metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). \[Time frame: 12 months\]
metabolic control - weight Changes	12 months	metabolic control - weight Changes of weight in kilograms. \[Time frame: 12 months\]
metabolic control - lipid profile Changes	12 months	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).; \[Time frame: 12 months\]
quality of life - Pediatric Quality of Life Inventory	12 months	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.; \[Time frame: 12 months\]
metabolic control - physical activity Changes	12 months	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.; \[Time frame: 12 months\]
metabolic control - caloric intake Changes	12 months	metabolic control - caloric intake Changes of caloric intake measured by a food diary. \[Time frame: 12 months\]
quality of life - Short-Form 36-Item Questionnaire	12 months	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.; \[Time frame: 12 months\]
patient and family satisfaction with care	12 months	patient and family satisfaction with care, measured by an ad-hoc devised form (named Co-Tenar), assessing qualitatively the satisfaction level.
safety	12 months	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).
costs	12 months	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).

Trial Locations

Locations (1)

Irccs - Istituto Delle Scienze Neurologiche; 🇮🇹 Bologna, Italy