NCT04838990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

February 21, 2021

Last Update Submit

January 19, 2022

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisremote visitstelemedicineremote patient monitoringremote monitoring

Outcome Measures

Primary Outcomes (1)

  • TMPQ

    Telemedicine Perception questionnaire (17-85, higher scores are better)

    1 week after intervention

Secondary Outcomes (1)

  • PPSM

    1 week after intervention

Other Outcomes (2)

  • Ancillary Analyses

    immediately after the intervention

  • Empirical Questionnaire

    1 week after intervention

Study Arms (3)

conventional visit

ACTIVE COMPARATOR

Regular outpatient visit

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

phone visit

EXPERIMENTAL

Remote visit via phone

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

video visit

EXPERIMENTAL

Remote visit via videochat

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

Interventions

EDSSOTHER

Neurological Exam - EDSS (Expanded Disability Status Scale)

conventional visitphone visitvideo visit
Discussion of symptoms, Patient reported outcome (MSIS)OTHER

Patients will be asked about their wellbeing

conventional visitphone visitvideo visit

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 35847524DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Patrick Altmann, MD PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2021

First Posted

April 9, 2021

Study Start

November 1, 2020

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request and through our local ERB.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Upon request and for 1 month
Access Criteria
reasonable request and upon approval of our local ERB

Locations

AU(1)