Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Narcolepsy
- Sponsor
- Azienda Usl di Bologna
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- excessive daytime sleepiness
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
excessive daytime sleepiness
Time Frame: 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 Outcomes
- metabolic control - glycemic profile Changes(12 months)
- metabolic control - weight Changes(12 months)
- metabolic control - lipid profile Changes(12 months)
- quality of life - Pediatric Quality of Life Inventory(12 months)
- metabolic control - caloric intake Changes(12 months)
- metabolic control - physical activity Changes(12 months)
- quality of life - Short-Form 36-Item Questionnaire(12 months)
- patient and family satisfaction with care(12 months)
- safety(12 months)
- costs(12 months)