PEP Flute-selfcare in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-09-01

Brief Summary

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Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.

The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.

The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

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Detailed Description

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It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group.

Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes.

Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400.

Link to detailed protocol paper will be added once published.

Conditions

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COVID-19 SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is designed as a randomised, controlled, open-label trial with two parallel groups and a primary endpoint of CAT-score after 30 days of intervention.

Randomization lists will be computer-generated using an appropriate statistical software and based upon permuted random blocks. The allocation ratio will be 1:1 stratified for the following baseline conditions:

* Sex
* Age (≥60 and \<60 years)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors will be blinded to treatment allocation where possible. This is of outmost importance, and participants are requested not to disclose their allocation when outcomes are assessed. To test the blinding efficacy, the outcome assessors are asked what treatment strategy they think a patient has received after assessments.

Study Groups

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Treatment group

The participants will be handed three airway resistances equivalent to a resistance of 10-20 cm H2O alongside one PEP flute. Two videos will guide the participants in use of the PEP flute; one with instructions of the rationale and how to use the flute, including how to choose the suitable resistance and one video, which gives instructions of hygienic maintenance.

Participants in the intervention group will be advised to continue use of their PEP flute in the active intervention period of 30 days or at least if they still have respiratory symptoms. They will receive daily text-messages to prompt their reporting and to use the PEP flute according to instructions.

Group Type EXPERIMENTAL

PEP flute

Intervention Type DEVICE

Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.

Control group

The participants in the control group will receive daily text-messages to prompt their reporting of CAT-scores. To avoid attrition of the trial due to early recovery of symptoms, the project manager will call the participants by phone at day 15 to ask them about their present condition (i.e. CAT-score) and address potential concerns of continued participation of the trial. Otherwise, they will only receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PEP flute

Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Positive SARS-CoV-2
* Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
* Access to use a smartphone
* Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
* Given informed consent

Exclusion Criteria

* Age \< 18 years.
* Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
* Hospitalised patients or citizens living in nursing homes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No