Evidence map›Paper›PMID 36574413›Full record

ArticlePloS one2022

Study protocol for connective tissue disease-associated interstitial lung disease trial (TEL-CTD-ILD): A randomized controlled trial of a home-based telemonitoring of treatment effects.

Sylwia Małysiak-Szpond, Maria Mozga, Ewa Miądlikowska, Joanna Miłkowska-Dymanowska, Adam Jerzy Białas, Wojciech Jerzy Piotrowski

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04428957 (Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% 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.

NCT04428957 naunknown statusnot on this map

Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)

TypeinterventionalSponsorMedical University of LodzRan2020 to 2022Enrolled60ConditionsConnective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue DiseasesArmsTelemonitoring
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

6 authors at 1 institution in 1 country.

Sylwia Małysiak-SzpondDepartment of Pneumology, I Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0002-3401-8976
Maria MozgaDepartment of Pneumology, I Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0003-0328-1461
Ewa MiądlikowskaDepartment of Pneumology, I Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0001-7496-0870
Joanna Miłkowska-DymanowskaDepartment of Pneumology, I Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0003-1287-9289
Adam Jerzy BiałasDepartment of Pathobiology of Respiratory Diseases, II Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.
Wojciech Jerzy PiotrowskiDepartment of Pneumology, I Chair of Internal Medicine, Medical University of Lodz, Lodz, Poland.ORCID 0000-0003-4506-6006
Medical University of Lodz · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInterstitial lung disease is one of the most severe pulmonary complications related to connective tissue diseases, resulting in substantial morbidity and mortality. Telepneumology has the potential to improve the long-term management of patients with CTD-ILD. We propose a randomized controlled trial to evaluate the efficacy of home-based telemonitoring of patients with CTD-ILD, in whom treatment was initiated. MATERIALS AND

methodsWe will conduct a randomized controlled trial comparing the standard of care with a telemonitoring program. Telemonitoring will start 10 to 14 days before treatment and will be carried out for three months of therapy. After initial training, patients from the intervention group will perform daily spirometry (FVC), transdermal pulse oximetry, pulse and blood pressure measurements, activity measurement (accelerometry), and assessment of the severity of cough and dyspnea. The results will be reported using a telemetric system designed by Mediguard® for this study. The primary outcome measure will be the health-related quality of life change using EQ-5D-5L questionnaire and St. George's Respiratory Questionnaire, as measured at stationary visits in both study groups. Secondary outcomes will include assessment of lung function, costs of health service utilization, satisfaction from being telemonitored, dyspnea by mMRC, fatigue by FAS, patients' adherence to recommended medications using the ASCD, anxiety and depression symptoms as measured by HADS, PHQ-9, and side effects of treatment. DISCUSSION: This is the first clinical trial protocol to evaluate home-based telemonitoring to optimize connective tissue disease-associated interstitial lung management. The study aims to provide data on the impact of telemonitoring on quality of life, evaluation of health status of patients with CTD-ILD using telemonitoring versus standard care. Additionally, we will evaluate the cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.

trial registrationClinicalTrials.gov Identifier: NCT04428957; Registered June 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04428957.

Indexed as

Connective Tissue DiseasesLung Diseases, InterstitialDyspneaHumansOximetryQuality of LifeRandomized Controlled Trials as Topic

Identifiers

PMID36574413
PMCPMC9794074
OpenAlexW4312207684

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.