PEP Flute-selfcare in COVID-19

NCT04530435 | Completed

• 1 other identifier: 0211-00023B
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; SARS-CoV-2; Respiratory symptoms; Positive expiratory pressure; Positive expiratory pressure flute; Airway clearance techniques

Outcome Measures

Primary Outcomes (1)

• Self-reported CAT-score (COPD Assessment Test)

  CAT-scores will be measured using a telephone administered questionnaire. The CAT-score is validated to evaluate symptoms in COPD patients. Eight items covers symptoms of cough, sputum, chest pain, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour. The eight items sum up to a range of 0-40 with higher scores indicating more respiratory impairment. Although validated for COPD-use, the CAT-scale is considered useful in the present study because several of the items (dyspnoea, cough, fatigue, sputum and pleuritic chest pain) previously have been used as outcome variables in pneumonia studies. The outcome assessment can be taken within + 1 week for the scheduled visit.

  Day 30.

Secondary Outcomes (3)

• Hospital admissions

  Up to day 30, 90 and 180.

• Use of antibiotics

  Up to day 30, 90 and 180.

• Self-reported CAT-score (COPD Assessment Test)

  Day 90, Day 180.

Other Outcomes (2)

• Serious Adverse Events

  During treatment, up to 30 days.

• General and respiratory symptoms

  Day 30, 90, Day 180.

Study Arms (2)

Treatment group

EXPERIMENTAL

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.

Device: PEP flute

Control group

NO INTERVENTION

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.

Interventions

PEP flute 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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals

Frederiksberg, 2000, Denmark

Location

Related Publications (2)

• Mollerup A, Henriksen M, Larsen SC, Bennetzen AS, Simonsen MK, Kofod LM, Knudsen JD, Nielsen XC, Weis N, Heitmann BL. 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. BMJ. 2021 Nov 24;375:e066952. doi: 10.1136/bmj-2021-066952.

  PMID: 34819329 DERIVED

• Mollerup A, Larsen SC, Bennetzen AS, Henriksen M, Simonsen MK, Weis N, Kofod LM, Heitmann BL. PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19. BMJ Open. 2021 Jun 30;11(6):e050582. doi: 10.1136/bmjopen-2021-050582.

  PMID: 34193503 DERIVED

MeSH Terms

Conditions

COVID-19; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berit L. Heitmann, Professor, Ph.D

  Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospitals, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: October 6, 2020
• Primary Completion: March 29, 2021
• Study Completion: September 1, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

DK (1)