TELEMS: Feasibility of Remote Patient Visits in MS (TELEMSRCT)

January 19, 2022 updated by: Patrick Altmann MD PhD, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • language barriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMPQ
Time Frame: 1 week after intervention
Telemedicine Perception questionnaire (17-85, higher scores are better)
1 week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPSM
Time Frame: 1 week after intervention
Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)
1 week after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ancillary Analyses
Time Frame: 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)
immediately after the intervention
Empirical Questionnaire
Time Frame: 1 week after intervention
Participants are given an opportunity to openly provide feedback
1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

September 1, 2021

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (ACTUAL)

April 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2157/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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