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Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD (OPTIS)

Primary Purpose

Neuromyelitis Optica

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NMOSDCopilot smartphone application
Sponsored by
Ad scientiam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuromyelitis Optica focused on measuring NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 to 60 years old
  • NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
  • With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
  • EDSS =< 7
  • With no evidence of relapse in the past 3 months before enrollment
  • Who have read the information sheet and signed the informed consent form
  • Able to use a smartphone
  • Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
  • Able to read language in which the mobile application is available and able to understand pictograms

Exclusion Criteria:

  • Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
  • Pregnant and nursing women
  • Person under guardianship or curatorship
  • Bedridden patients or patients with a daily activity of less than 2 hours per day
  • Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
  • Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.

Sites / Locations

  • Massachussets General HospitalRecruiting
  • Hôpital Roger SalengroRecruiting
  • CHU de Montpellier
  • Hopital Pasteur 2Recruiting
  • Hopital La Pitié Salpétrière
  • CHU Rouen
  • Hopital de HautepierreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NMOSDCopilot

Arm Description

Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months

Outcomes

Primary Outcome Measures

To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline

Secondary Outcome Measures

To assess reproducibility between in-clinic and at-home e-active tests
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline and between and month 6 and month 6- 7days
To assess test-retest reliability of at-home e-active tests
Intraclass correlation coefficient of e-active tests
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests
To assess the adverse events related to of the mobile application use.
descriptive analysis of adverse events (AEs) related to the use of the application.
To assess pain
Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome
To assess fatigue
Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome
To assess bladder control
Bladder Control Scale (0-22) higher score meaning a worse outcome
To assess bowel control
Bowel Control Scale (0-22) higher score meaning a worse outcome
To assess depression
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
To assess quality of life
p-value of multivariate analysis for non-parametric data
To assess disability
Expanded Disability Status Scale (0-10), higher score meaning a worse outcome
To assess satisfaction and user experience with the smartphone application and the web dashboard
Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)
To assess at-home compliance and adherence to the patient application
Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).
To compare results obtained with at home MVT and in-clinic OCT-scan
The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF & GCIP layer thickness

Full Information

First Posted
September 7, 2022
Last Updated
October 19, 2023
Sponsor
Ad scientiam
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1. Study Identification

Unique Protocol Identification Number
NCT05566769
Brief Title
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
Acronym
OPTIS
Official Title
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ad scientiam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica
Keywords
NMO, NMOSD, Neuromyelitis optica, Neuromyelitis optica spectrum disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMOSDCopilot
Arm Type
Experimental
Arm Description
Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months
Intervention Type
Device
Intervention Name(s)
NMOSDCopilot smartphone application
Intervention Description
NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression
Primary Outcome Measure Information:
Title
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test
Description
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline
Time Frame
Standard tests results at Baseline versus e-active tests results at D0 + 7 days
Secondary Outcome Measure Information:
Title
To assess reproducibility between in-clinic and at-home e-active tests
Description
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline and between and month 6 and month 6- 7days
Time Frame
Baseline, day 7, month 6 - 7 days, month 6
Title
To assess test-retest reliability of at-home e-active tests
Description
Intraclass correlation coefficient of e-active tests
Time Frame
Month 1, month 2, month 3, month 4, month 5
Title
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test
Description
Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests
Time Frame
Baseline, month 6, month 12
Title
To assess the adverse events related to of the mobile application use.
Description
descriptive analysis of adverse events (AEs) related to the use of the application.
Time Frame
through study completion, 21 months
Title
To assess pain
Description
Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome
Time Frame
Month 3, month 6, month 12
Title
To assess fatigue
Description
Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome
Time Frame
Month 3, month 6, month 12
Title
To assess bladder control
Description
Bladder Control Scale (0-22) higher score meaning a worse outcome
Time Frame
Month 3, month 6, month 12
Title
To assess bowel control
Description
Bowel Control Scale (0-22) higher score meaning a worse outcome
Time Frame
Month 3, month 6, month 12
Title
To assess depression
Description
Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome
Time Frame
Month 3, month 6, month 12
Title
To assess quality of life
Description
p-value of multivariate analysis for non-parametric data
Time Frame
Baseline, month 6, month 12
Title
To assess disability
Description
Expanded Disability Status Scale (0-10), higher score meaning a worse outcome
Time Frame
Baseline, month 6, month 12
Title
To assess satisfaction and user experience with the smartphone application and the web dashboard
Description
Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome)
Time Frame
Through study completion, 21 months
Title
To assess at-home compliance and adherence to the patient application
Description
Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.).
Time Frame
Through study completion, 21 months
Title
To compare results obtained with at home MVT and in-clinic OCT-scan
Description
The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF & GCIP layer thickness
Time Frame
Through study completion, 21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 60 years old NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only) With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics) EDSS =< 7 With no evidence of relapse in the past 3 months before enrollment Who have read the information sheet and signed the informed consent form Able to use a smartphone Owns a personal smartphone which version is above 13 for IOS and 8 for Android included Able to read language in which the mobile application is available and able to understand pictograms Exclusion Criteria: Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning Pregnant and nursing women Person under guardianship or curatorship Bedridden patients or patients with a daily activity of less than 2 hours per day Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment) Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.
Facility Information:
Facility Name
Massachussets General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Levy, MD, PhD
Phone
617-726-7565
Email
MLEVY11@mgh.harvard.edu
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene Zephir, Pr
Phone
03 20 44 59 62
Email
Helene.ZEPHIR@chu-lille.fr
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Labauge, Pr
Phone
04 67 33 94 69
Email
p-labauge@chu-montpellier.fr
Facility Name
Hopital Pasteur 2
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Cohen, Dr
Phone
04 92 03 77 77
Email
cohen.m@chu-nice.fr
Facility Name
Hopital La Pitié Salpétrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Maillart, Dr
Phone
01 42 17 62 05
Email
elisabeth.maillart@aphp.fr
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Bourre, Dr
Phone
02 32 88 89 90
Email
Bertrand.Bourre@chu-rouen.fr
Facility Name
Hopital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme De Sèze, Pr
Phone
03 88 12 85 91
Email
Jerome.DESEZE@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Jérôme De Sèze

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

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