Evidence map›Paper›PMID 33882893›Full record

Trial reportBMC pulmonary medicine2021

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF.

Stephanie Thee, Mirjam Stahl, Rainald Fischer, Sivagurunathan Sutharsan, Manfred Ballmann, Axel Müller, Daniel Lorenz, Dominika Urbanski-Rini, Franziska Püschner, Volker Eric Amelung and 2 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Nebuliser systems for drug delivery in cystic fibrosis.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Telemedicine and Its Application in Cystic Fibrosis.Journal of personalized medicine · 2023
    Review
  12. Review
  13. Article
  14. Review
  15. Digital healthcare in cystic fibrosis. Learning from the pandemic to innovate future care (Commentary).Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
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

12 authors at 6 institutions in 1 country.

Stephanie TheeDepartment of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-9090-7869
Mirjam StahlDepartment of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-6941-8315
Rainald FischerCystic Fibrosis Centre Munich-West, Munich, Germany.
Sivagurunathan SutharsanDepartment of Pulmonary Medicine, Division of Cystic Fibrosis, University Medicine Essen -Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.
Manfred BallmannDepartment of Pediatrics, University Medicine Rostock, Rostock, Germany.ORCID http://orcid.org/0000-0003-4480-1312
Axel Müllerm.Doc GmbH, Köln, Germany.
Daniel LorenzThieme TeleCare Ltd., Stuttgart, Germany.
Dominika Urbanski-RiniPrivate Institute for Applied Health Services Research (Inav) GmbH, Berlin, Germany.ORCID http://orcid.org/0000-0002-7069-0911
Franziska PüschnerPrivate Institute for Applied Health Services Research (Inav) GmbH, Berlin, Germany.ORCID http://orcid.org/0000-0002-5746-6608
Volker Eric AmelungPrivate Institute for Applied Health Services Research (Inav) GmbH, Berlin, Germany.
Carola FuchsPARI Medical Holding GmbH, Starnberg, Germany.
Marcus Alexander MallDepartment of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité - Universitätsmedizin Berlin, Berlin, Germany. marcus.mall@charite.de.ORCID http://orcid.org/0000-0002-4057-2199
German Center for Lung Research · DECharité - Universitätsmedizin Berlin · DEPARI (Germany) · DERuhrlandklinik · DEThieme Medical Publishers (Germany) · DEUniversity of Rostock · DE

Funding

German Innovation Fund 01NVF19008
6 · The paper itself

Abstract

backgroundThe extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies.

methodsThis is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms. DISCUSSION: This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF.

trial registrationThis study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642 ).

Indexed as

Patient Education as TopicTelemedicineAdolescentAdultChildCystic FibrosisHumansMonitoring, AmbulatoryAdherenceCystic fibrosisHome spirometryTelemedicine

Identifiers

PMID33882893
PMCPMC8058751
OpenAlexW3154957249

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.