Back to resultsTELEMS: Feasibility of Remote Patient Visits in MS (TELEMSRCT)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EDSS
Discussion of symptoms, Patient reported outcome (MSIS)
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Sclerosis focused on measuring multiple sclerosis, remote visits, telemedicine, remote patient monitoring, remote monitoring
Eligibility Criteria
Inclusion Criteria:
- confirmed diagnosis of any type of MS
- own a phone/smartphone/computer
- informed consent
Exclusion Criteria:
- language barriers
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
conventional visit
phone visit
video visit
Arm Description
Regular outpatient visit
Remote visit via phone
Remote visit via videochat
Outcomes
Primary Outcome Measures
TMPQ
Telemedicine Perception questionnaire (17-85, higher scores are better)
Secondary Outcome Measures
PPSM
Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)
Full Information
NCT ID
NCT04838990
First Posted
February 21, 2021
Last Updated
January 19, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04838990
Brief Title
TELEMS: Feasibility of Remote Patient Visits in MS
Acronym
TELEMSRCT
Official Title
TELE MS RCT: A Randomized Controlled Trial to Evaluate Feasibility of Remote Patient Visits in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
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
This trials randomizes patients with multiple sclerosis (MS, pwMS) to a remote visit (via phone or videochat) or a regular outpatient visit. Outcomes include satisfaction on the patients' and doctor's side.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, remote visits, telemedicine, remote patient monitoring, remote monitoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional visit
Arm Type
Active Comparator
Arm Description
Regular outpatient visit
Arm Title
phone visit
Arm Type
Experimental
Arm Description
Remote visit via phone
Arm Title
video visit
Arm Type
Experimental
Arm Description
Remote visit via videochat
Intervention Type
Other
Intervention Name(s)
EDSS
Intervention Description
Neurological Exam - EDSS (Expanded Disability Status Scale)
Intervention Type
Other
Intervention Name(s)
Discussion of symptoms, Patient reported outcome (MSIS)
Intervention Description
Patients will be asked about their wellbeing
Primary Outcome Measure Information:
Title
TMPQ
Description
Telemedicine Perception questionnaire (17-85, higher scores are better)
Time Frame
1 week after intervention
Secondary Outcome Measure Information:
Title
PPSM
Description
Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)
Time Frame
1 week after intervention
Other Pre-specified Outcome Measures:
Title
Ancillary Analyses
Description
Subgroup analyses comparing scores on the TMPQ above and below the median (Telemedicine Perception questionnaire, 17-85 points, higher scores are better) with clinical characteristics (EDSS and MSIS and Age)
Time Frame
immediately after the intervention
Title
Empirical Questionnaire
Description
Participants are given an opportunity to openly provide feedback
Time Frame
1 week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed diagnosis of any type of MS
own a phone/smartphone/computer
informed consent
Exclusion Criteria:
language barriers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Altmann, MD PhD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared upon reasonable request and through our local ERB.
IPD Sharing Time Frame
Upon request and for 1 month
IPD Sharing Access Criteria
reasonable request and upon approval of our local ERB
Citations:
PubMed Identifier
35847524
Citation
Altmann P, Leutmezer F, Ponleitner M, Ivkic D, Krajnc N, Rommer PS, Berger T, Bsteh G. Remote visits for people with multiple sclerosis during the COVID-19 pandemic in Austria: The TELE MS randomized controlled trial. Digit Health. 2022 Jul 11;8:20552076221112154. doi: 10.1177/20552076221112154. eCollection 2022 Jan-Dec.
Results Reference
derived
Learn more about this trial
TELEMS: Feasibility of Remote Patient Visits in MS
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