TElemedicine for NARcolepsy (TENAR)
Primary Purpose
Narcolepsy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tele-multidisciplinary care
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Narcolepsy
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.
Sites / Locations
- Irccs - Istituto Delle Scienze Neurologiche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Tele-multidisciplinary participants
In-office standard participants
Arm Description
Patients undergoing televisit
Patients undergoing in-office visits
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
metabolic control - weight Changes
metabolic control - weight Changes of weight in kilograms. [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]
metabolic control - glycemic profile Changes
metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). [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]
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]
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]
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]
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.
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).
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).
Full Information
NCT ID
NCT04316286
First Posted
January 30, 2020
Last Updated
June 6, 2023
Sponsor
Azienda Usl di Bologna
Collaborators
University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT04316286
Brief Title
TElemedicine for NARcolepsy
Acronym
TENAR
Official Title
Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Usl di Bologna
Collaborators
University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-multidisciplinary participants
Arm Type
Experimental
Arm Description
Patients undergoing televisit
Arm Title
In-office standard participants
Arm Type
Other
Arm Description
Patients undergoing in-office visits
Intervention Type
Procedure
Intervention Name(s)
Tele-multidisciplinary care
Intervention Description
Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists
Primary Outcome Measure Information:
Title
excessive daytime sleepiness
Description
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
Secondary Outcome Measure Information:
Title
metabolic control - weight Changes
Description
metabolic control - weight Changes of weight in kilograms. [Time frame: 12 months]
Time Frame
12 months
Title
metabolic control - lipid profile Changes
Description
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
Title
metabolic control - glycemic profile Changes
Description
metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). [Time frame: 12 months]
Time Frame
12 months
Title
metabolic control - caloric intake Changes
Description
metabolic control - caloric intake Changes of caloric intake measured by a food diary. [Time frame: 12 months]
Time Frame
12 months
Title
metabolic control - physical activity Changes
Description
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
Title
quality of life - Short-Form 36-Item Questionnaire
Description
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
Title
quality of life - Pediatric Quality of Life Inventory
Description
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
Title
patient and family satisfaction with care
Description
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
Title
safety
Description
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
Title
costs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Plazzi
Organizational Affiliation
IRCCS Istituto delle Scienze Neurologiche di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irccs - Istituto Delle Scienze Neurologiche
City
Bologna
ZIP/Postal Code
40139
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32393279
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.
Results Reference
derived
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TElemedicine for NARcolepsy
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