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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04838990
Recruitment Status : Completed
First Posted : April 9, 2021
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Patrick Altmann MD PhD, Medical University of Vienna

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : November 1, 2020
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. TMPQ [ Time Frame: 1 week after intervention ]
    Telemedicine Perception questionnaire (17-85, higher scores are better)


Secondary Outcome Measures :
  1. PPSM [ Time Frame: 1 week after intervention ]
    Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)


Other Outcome Measures:
  1. 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)

  2. Empirical Questionnaire [ Time Frame: 1 week after intervention ]
    Participants are given an opportunity to openly provide feedback



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • language barriers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838990


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Patrick Altmann, MD PhD Medical University of Vienna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick Altmann MD PhD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04838990    
Other Study ID Numbers: 2157/2020
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared upon reasonable request and through our local ERB.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Upon request and for 1 month
Access Criteria: reasonable request and upon approval of our local ERB

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick Altmann MD PhD, Medical University of Vienna:
multiple sclerosis
remote visits
telemedicine
remote patient monitoring
remote monitoring
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases