Effect of PEP flute self-care versus usual care in early covid-19: Non-drug, open label, randomised controlled trial in a Danish community setting

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Dokumenter

  • Full text

    Forlagets udgivne version, 527 KB, PDF-dokument

OBJECTIVE To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19. DESIGN Non-drug, open label, randomised controlled trial. SETTING Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021. PARTICIPANTS Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19. INTERVENTION Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention. MAIN OUTCOME MEASURES Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days’ follow-up. RESULTS 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of −1.2 points (95% confidence interval −2.1 to −0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported. CONCLUSIONS In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores.

OriginalsprogEngelsk
Artikelnummere066952
TidsskriftThe BMJ
Vol/bind375
ISSN0959-8146
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
Contributors: AM conceived the study idea and MKS gathered the project team together. AM, MKS, SCL, MH, LMK, NW, and BLH contributed to the study conception and design. AM was the project manager. LMK oversaw the production of instruction videos. ASB steered the setup of data management system, supervised by MH. JDK and XCN provided the data of individuals who tested positive of SARS-CoV-2. AM and ASB handled recruitment, data collection, deliverance of intervention, and assessment of all participants. AM handled the telephone hotline and responded to requests for advice from participants, including regarding any adverse events. MH developed the allocation sequence. MH and SCL managed the data and statistical analysis. NW had the medical responsibility during conduct of the trial, and BLH was the project lead. AM drafted the first version of the manuscript. All authors read and critically revised the manuscript, and all authors approved the final manuscript and submission of the article. The article was written according to ICMJE guidelines without the use of professional writers. BLH is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Funding: The study was supported by Innovation Fund Denmark (grant 0211-00023B) and a grant (unnumbered) from the Danish Nursing Council. The Parker Institute, Bispebjerg-Frederiksberg hospital, is supported by a core grant from the Oak Foundation (grant OCAY-18-774). The funders had no role in the study design, conduct of the trial, data analysis and interpretation, writing of the manuscript, or the decision to publish the study. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from Innovation Fund Denmark, the Danish Nursing Council, and the Oak Foundation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.

ID: 288122755