{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T09:03:54Z","timestamp":1774602234502,"version":"3.50.1"},"reference-count":28,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T00:00:00Z","timestamp":1625011200000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"The Danish Nursing Council","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}]},{"DOI":"10.13039\/100012774","name":"Innovationsfonden","doi-asserted-by":"publisher","award":["0211-00023B"],"award-info":[{"award-number":["0211-00023B"]}],"id":[{"id":"10.13039\/100012774","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,5,27]]},"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Infection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>In this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      The study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04530435\">NCT04530435<\/jats:ext-link>\n                      ). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04530435\">NCT04530435<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050582","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T12:48:01Z","timestamp":1625057281000},"page":"e050582","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04530435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04530435","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct04530435","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04530435","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8161-2214","authenticated-orcid":false,"given":"Annette","family":"Mollerup","sequence":"first","affiliation":[{"name":"Research Unit for Dietary Studies, The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark"},{"name":"The Bachelor of Science in Nursing Programme, The Danish Deaconess Community Frederiksberg, University College Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sofus Christian","family":"Larsen","sequence":"additional","affiliation":[{"name":"Research Unit for Dietary Studies, The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita Selmer","family":"Bennetzen","sequence":"additional","affiliation":[{"name":"Research Unit for Dietary Studies, The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marius","family":"Henriksen","sequence":"additional","affiliation":[{"name":"The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark"},{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mette Kildevaeld","family":"Simonsen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Copenhagen University Hospital - Bispebjerg, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3133-2724","authenticated-orcid":false,"given":"Nina","family":"Weis","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Infectious Diseases, Copenhagen University Hospital - Hvidovre, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linette Marie","family":"Kofod","sequence":"additional","affiliation":[{"name":"Department of Physio- and Occupational Therapy and PMR-C, Copenhagen University Hospital - Hvidovre, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6809-4504","authenticated-orcid":false,"given":"Berit Lilienthal","family":"Heitmann","sequence":"additional","affiliation":[{"name":"Research Unit for Dietary Studies, The Parker Institute, Frederiksberg, Copenhagen University Hospital, Frederiksberg, Denmark"},{"name":"Section for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,6,30]]},"reference":[{"key":"2025121219410966000_11.6.e050582.1","doi-asserted-by":"crossref","first-page":"506","DOI":"10.1016\/S2213-2600(20)30161-2","article-title":"Intensive care management of coronavirus disease 2019 (COVID-19): challenges and recommendations","volume":"8","author":"Phua","year":"2020","journal-title":"Lancet Respir Med"},{"key":"2025121219410966000_11.6.e050582.2","doi-asserted-by":"crossref","unstructured":"Reilev M , Kristensen KB , Potteg\u00e5rd A . Characteristics and predictors of hospitalization and death in the first 9,519 cases with a positive RT-PCR test for SARS-CoV-2 in Denmark: a nationwide cohort. medRxiv 2020.","DOI":"10.1101\/2020.05.24.20111823"},{"key":"2025121219410966000_11.6.e050582.3","doi-asserted-by":"crossref","first-page":"68","DOI":"10.1111\/aas.13701","article-title":"Characteristics, interventions, and longer term outcomes of COVID-19 ICU patients in Denmark-A nationwide, observational study","volume":"65","author":"Haase","year":"2021","journal-title":"Acta Anaesthesiol Scand"},{"key":"2025121219410966000_11.6.e050582.4","unstructured":"WHO . Covid-19: icd-10 coding guidance 1 18, 2020. Available: https:\/\/www.who.int\/classifications\/icd\/COVID-19-coding-icd10.pdf [Accessed 12 Feb 2021]."},{"key":"2025121219410966000_11.6.e050582.5","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m1985","article-title":"Features of 20\u2009133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study","volume":"369","author":"Docherty","year":"2020","journal-title":"BMJ Br Med journal"},{"key":"2025121219410966000_11.6.e050582.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2007764"},{"key":"2025121219410966000_11.6.e050582.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2021436"},{"key":"2025121219410966000_11.6.e050582.8","doi-asserted-by":"crossref","unstructured":"Kofod LM , Jeschke KN , Krogh-Madsen R . Kontinuerlig CPAP til patienter Kontinuerlig CPAP til patienter Med COVID-19 Med COVID-19. Ugeskr L\u00e6ger 2020:1\u20138.","DOI":"10.1080\/20018525.2021.1910191"},{"key":"2025121219410966000_11.6.e050582.9","doi-asserted-by":"crossref","first-page":"1191","DOI":"10.3390\/jcm9041191","article-title":"Helmet CPAP to treat acute hypoxemic respiratory failure in patients with COVID-19: a management strategy proposal","volume":"9","author":"Radovanovic","year":"2020","journal-title":"J Clin Med"},{"key":"2025121219410966000_11.6.e050582.10","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2013-203425"},{"key":"2025121219410966000_11.6.e050582.11","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24262"},{"key":"2025121219410966000_11.6.e050582.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2014.11.003"},{"key":"2025121219410966000_11.6.e050582.13","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/resp.13459","article-title":"Airway clearance, mucoactive therapies and pulmonary rehabilitation in bronchiectasis","volume":"24","author":"O\"Neill","year":"2019","journal-title":"Respirology"},{"key":"2025121219410966000_11.6.e050582.14","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"2025121219410966000_11.6.e050582.15","doi-asserted-by":"crossref","unstructured":"Sudre CH , Murray B , Varsavsky T . Attributes and predictors of Long-COVID: analysis of COVID cases and their symptoms collected by the Covid symptoms study app. medRxiv 2020.","DOI":"10.1101\/2020.10.19.20214494"},{"key":"2025121219410966000_11.6.e050582.16","unstructured":"SSI . Covid-19 i Danmark. Epidemiologisk trend og fokus: Symptomer. Copenhagen 2020."},{"key":"2025121219410966000_11.6.e050582.17","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S276825"},{"key":"2025121219410966000_11.6.e050582.18","unstructured":"SSI . COVIDmeter. Available: https:\/\/covid19.ssi.dk\/overvagningsdata\/undersoegelser\/covidmeter [Accessed 4 Feb 2021]."},{"key":"2025121219410966000_11.6.e050582.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2025121219410966000_11.6.e050582.20","first-page":"CD008328","article-title":"Airway clearance techniques for chronic obstructive pulmonary disease","author":"Osadnik","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121219410966000_11.6.e050582.21","doi-asserted-by":"publisher","DOI":"10.1113\/jphysiol.2011.213157"},{"key":"2025121219410966000_11.6.e050582.22","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-14-1"},{"key":"2025121219410966000_11.6.e050582.23","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00102509"},{"key":"2025121219410966000_11.6.e050582.24","unstructured":"Region Sj\u00e6lland . Sundhedsfagligt indhold I TeleKol, 2017. Available: https:\/\/www.regionsjaelland.dk\/Sundhed\/samarbejde-og-indsatser\/Telesundhed-KOL\/Documents\/TeleKOL LANDSDEL SJ\u00c6LLANDS sundhedsfaglige anbefalinger v1.01.pdf"},{"key":"2025121219410966000_11.6.e050582.25","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1497.1997.00074.x"},{"key":"2025121219410966000_11.6.e050582.26","first-page":"50","article-title":"\u00c5nden\u00f8d p\u00e5 8. uge","volume":"6","author":"Andersen","year":"2020","journal-title":"Sygeplejersken"},{"key":"2025121219410966000_11.6.e050582.27","unstructured":"Jones P , Jenkins C , Agusti A . Healthcare professional user guide. The COPD Assessment Test (CAT), 2018: 1\u201320. www.catestonline.org"},{"key":"2025121219410966000_11.6.e050582.28","unstructured":"GCP-units . The Danish good clinical practice units. Available: https:\/\/gcp-enhed.dk\/english\/ [Accessed 16 Feb 2021]."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-050582","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T03:41:20Z","timestamp":1765597280000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-050582"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":28,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6,30]]},"published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1136\/bmjopen-2021-050582"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-050582","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6]]}}}