Evidence map›Paper›PMID 31276502›Full record

Trial reportPloS one2019

RebiQoL: A randomized trial of telemedicine patient support program for health-related quality of life and adherence in people with MS treated with Rebif.

Anne-Marie Landtblom, Dimitri Guala, Claes Martin, Stefan Olsson-Hau, Sara Haghighi, Lillemor Jansson, Sten Fredrikson

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01791244 (A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01791244 phase4completednot on this map

A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2013 to 2016Enrolled93ConditionsMultiple Sclerosis, Relapsing-RemittingArmsRebif®
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Observational
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 1 country.

Anne-Marie LandtblomDepartment of Neuroscience/Neurology, Uppsala University, Uppsala, Sweden.
Dimitri GualaMerck AB, Stockholm, Sweden.ORCID 0000-0003-2245-7557
Claes MartinNeurology Unit, Division of Internal Medicine, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Stefan Olsson-HauDepartment of Neurology, Skåne University Hospital, Malmö, Sweden.
Sara HaghighiDepartment of Neurology, Motala Hospital, Motala, Sweden.
Lillemor JanssonDepartment of Neurology, Academic Hospital, Uppsala, Sweden.
Sten FredriksonDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Karolinska Institutet · SELasarettet i Motala · SESkåne University Hospital · SEStockholm University · SEUppsala University · SEUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

RebiQoL was a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (MSP) on health-related quality of life (HRQoL) in patients with relapsing-remitting MS (RRMS) being administered with Rebif with the RebiSmart device. The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological part of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only. The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (difference of 0.48, 95% CI: -8.30-9.25, p = 0.91) or secondary outcomes (p>0.05). Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group (OR 3.5, 95% CI 0.85-14.40, p = 0.08) although not statistically significant. No unexpected adverse events occurred. This study did not show a statistically significant effect of the particular form of teleintervention used in this study on HRQoL as compared to pure technical support, for MS patients already receiving Rebif with the RebiSmart device. Trial Registration: ClinicalTrials.gov: NCT01791244.

Indexed as

Quality of LifeTelemedicineAdolescentAdultAgedFemaleHumansInterferon beta-1aMaleMedication AdherenceMiddle AgedMultiple Sclerosis, Relapsing-RemittingInterferon beta-1a

Identifiers

PMID31276502
PMCPMC6611587
OpenAlexW2955643247

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.