TELEMSRCT: TELEMS: Feasibility of Remote Patient Visits in MS

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT04838990

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: EDSS Other: Discussion of symptoms, Patient reported outcome (MSIS)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

TELE MS RCT: A Randomized Controlled Trial to Evaluate Feasibility of Remote Patient Visits in People With Multiple Sclerosis

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional visit Regular outpatient visit	Other: EDSS Neurological Exam - EDSS (Expanded Disability Status Scale) Other: Discussion of symptoms, Patient reported outcome (MSIS) Patients will be asked about their wellbeing
Experimental: phone visit Remote visit via phone	Other: EDSS Neurological Exam - EDSS (Expanded Disability Status Scale) Other: Discussion of symptoms, Patient reported outcome (MSIS) Patients will be asked about their wellbeing
Experimental: video visit Remote visit via videochat	Other: EDSS Neurological Exam - EDSS (Expanded Disability Status Scale) Other: Discussion of symptoms, Patient reported outcome (MSIS) Patients will be asked about their wellbeing

Arm

Intervention/Treatment

Active Comparator: conventional visit

Regular outpatient visit

Other: EDSS

Neurological Exam - EDSS (Expanded Disability Status Scale)

Other: Discussion of symptoms, Patient reported outcome (MSIS)

Patients will be asked about their wellbeing

Experimental: phone visit

Remote visit via phone

Other: EDSS

Neurological Exam - EDSS (Expanded Disability Status Scale)

Other: Discussion of symptoms, Patient reported outcome (MSIS)

Patients will be asked about their wellbeing

Experimental: video visit

Remote visit via videochat

Other: EDSS

Neurological Exam - EDSS (Expanded Disability Status Scale)

Other: Discussion of symptoms, Patient reported outcome (MSIS)

Patients will be asked about their wellbeing

Outcome Measures

Primary Outcome Measures

TMPQ [1 week after intervention]
Telemedicine Perception questionnaire (17-85, higher scores are better)

Secondary Outcome Measures

PPSM [1 week after intervention]
Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)

Other Outcome Measures

Ancillary Analyses [immediately after the intervention]
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)
Empirical Questionnaire [1 week after intervention]
Participants are given an opportunity to openly provide feedback

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

confirmed diagnosis of any type of MS
own a phone/smartphone/computer
informed consent

Exclusion Criteria:

language barriers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Patrick Altmann, MD PhD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrick Altmann MD PhD, Principal Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04838990

Other Study ID Numbers:

2157/2020

First Posted:

Apr 9, 2021

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Patrick Altmann MD PhD, Principal Investigator, Medical University of Vienna

multiple sclerosis

remote visits

telemedicine

remote patient monitoring

remote monitoring

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Jan 21, 2022