Multiple SclerosisTELEMSRCTNCT04838990
TELEMS: Feasibility of Remote Patient Visits in MS
A study testing EDSS and Discussion of symptoms, Patient reported outcome (MSIS) in people with Multiple Sclerosis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- EDSS and Discussion of symptoms, Patient reported outcome (MSIS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed diagnosis of any type of MS
- own a phone/smartphone/computer
- informed consent
Who cannot join
- language barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- EDSS, Discussion of symptoms, Patient reported outcome (MSIS)
- Keywords
- multiple sclerosis, remote visits, telemedicine, remote patient monitoring, remote monitoring
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDSSOther
Neurological Exam - EDSS (Expanded Disability Status Scale)
Discussion of symptoms, Patient reported outcome (MSIS)Other
Patients will be asked about their wellbeing
| Study group | Role | What they receive |
|---|---|---|
| conventional visit | Active comparator | Regular outpatient visit Receives: Other: EDSS; Other: Discussion of symptoms, Patient reported outcome (MSIS) |
| phone visit | Experimental | Remote visit via phone Receives: Other: EDSS; Other: Discussion of symptoms, Patient reported outcome (MSIS) |
| video visit | Experimental | Remote visit via videochat Receives: Other: EDSS; Other: Discussion of symptoms, Patient reported outcome (MSIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMPQ
Telemedicine Perception questionnaire (17-85, higher scores are better)
Measured: 1 week after intervention
Secondary outcomes (1)
PPSM
Patient and Physician Satisfaction with monitoring (6-30, higher scores are better)
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Nov 2020
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Altmann MD PhD, Medical University of Vienna
- Investigators
- Patrick Altmann, MD PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838990
- Sponsor's protocol ID
- 2157/2020
- Acronym
- TELEMSRCT
- Status last verified
- Jan 2022
- First submitted
- 21 Feb 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request and through our local ERB.
Publications
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.
PubMed 35847524
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELE MS RCT: A Randomized Controlled Trial to Evaluate Feasibility of Remote Patient Visits in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04838990
- Acronym / sponsor ID
- TELEMSRCT / 2157/2020
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, remote visits, telemedicine, remote patient monitoring, remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| conventional visit | Active comparator | Other: EDSS, Other: Discussion of symptoms, Patient reported outcome (MSIS)Regular outpatient visit |
| phone visit | Experimental | Other: EDSS, Other: Discussion of symptoms, Patient reported outcome (MSIS)Remote visit via phone |
| video visit | Experimental | Other: EDSS, Other: Discussion of symptoms, Patient reported outcome (MSIS)Remote visit via videochat |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed diagnosis of any type of MS
- own a phone/smartphone/computer
- informed consent
Key exclusion criteria (1 listed)
- language barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDSSNeurological Exam - EDSS (Expanded Disability Status Scale) | Other | conventional visit, phone visit, video visit |
| Discussion of symptoms, Patient reported outcome (MSIS)Patients will be asked about their wellbeing | Other | conventional visit, phone visit, video visit |
Primary outcome
TMPQ
Time frame: 1 week after intervention
Telemedicine Perception questionnaire (17-85, higher scores are better)
1 secondary outcome
PPSM
Time frame: 1 week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 35847524Altmann 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.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request and through our local ERB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Altmann, MD PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDSS and Discussion of symptoms, Patient reported outcome (MSIS) in people with Multiple Sclerosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMPQ (time frame: 1 week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.