Clinical trial NCT05107440: BREATHE: Virtual Self-management for Long COVID-19
Official title: BREATHE: A Mixed-methods Evaluation of a Virtual Self-management Program for People Living With Long COVID-19 in Alberta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Long COVID
Post COVID-19 condition
Post-acute COVID-19 syndrome
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A mixed-methods evaluation of a virtual self-management program for people living with long COVID in Alberta.

Detailed description: Background \& Rationale

The possible volume of current and future long COVID patients in Alberta is so high (based on the above numbers, more than 20,000) that primary care may not be able to cope given current resources (for example, the waitlist for post-COVID-19 clinics is \>3 months). While a Rehabilitation Advice Line and online resources have been created for Albertans with long COVID, many patients are struggling and need more support for self-management to promote recovery. Alongside shortness of breath, long COVID is often characterized by chronic fatigue that is clinically relevant and is at least as severe as fatigue in several other clinical conditions. Other symptoms can include dry cough, cognitive impairment ("brain fog"), heart palpitations, chest tightness, and dizziness. Individuals living with long COVID describe an unpredictable and episodic trajectory with a relapse-remitting nature. Since February 2021, the investigators have been delivering a free virtual program for people with long COVID in Alberta due to an overwhelming demand for physical therapy/support for chronic symptoms. This program has undergone iterative improvements based on new understanding and participant feedback. The program is feasible given the ongoing demand (rapid recruitment of 16-18 participants in three previous programs) and high attendance (\>80%). In the most recent cohort, of the participants that responded, 100% found the program helpful, 91% felt more confident about managing symptoms, 91% would recommend the program to other people with long COVID (feedback collected using a brief anonymous survey as part of quality improvement). The objective of this exploratory study is to collect quantitative and qualitative data to evaluate the safety and acceptability of a virtual self-management program for people living with long COVID. Pre-to-post intervention patient-reported outcomes (PROs) will also be collected, and the proportion of participants improving or deteriorating will be reported.

Methods

This is a mixed-methods evaluation of a free, virtual, multidisciplinary, patient-centred self-management program for long COVID. The BREATHE program provides education on Breathing, Rest/recovery, Education, Activity management, Thinking/cognition, Healthy voice strategies, and Eating/nutrition. Two previous pilot iterations of the program took place earlier in 2021, and the BREATHE program in its current format is currently taking place (Aug-Oct, 2021) and will be repeated from Oct-Dec 2021. There is no required in-person element to this study; assessments and program sessions take place virtually via REDCap (secure data collection platform) and Zoom (secure video platform). Participant eligibility criteria were based on the World Health Organization's clinical case definition for post COVID-19 condition.

BREATHE is an eight-week intervention involving two sessions per week, hosted virtually on Zoom. The content was developed based on clinical experience, best available evidence for the management of specific symptoms (chronic fatigue, post-exertional malaise, breathing discomfort, sleep disruption) in other conditions, including post-viral syndromes, and the current understanding and recommendations for rehabilitation of people living with long COVID. The remaining sessions were developed and delivered by content experts (occupational therapist, nutritional consultant, mental health professional) who are familiar with the unique difficulties that people with long COVID face. The investigators have incorporated breakout rooms to include elements of peer support (affirmation of feelings and behaviours, expressions of empathy and reassurance, support for coping with negative emotions, encouraging persistence and optimism). Intervention attendance and adverse events will be reported. Because this is a self-management intervention, the main pre-post outcome of interest is participants' confidence in managing their symptoms and daily activities. Additional outcomes are fatigue, breathing discomfort, functional status and health-related quality of life. To gain participant perspectives on the BREATHE program, participants will be asked to take part in a one-on-one interview via Zoom within two weeks following the final intervention session. A semi-structured interview guide was developed, informed by the Theoretical Framework of Acceptability.

Eligibility criteria: Eligibility criteria were based on the World Health Organization's clinical case definition for post-COVID-19 condition, which "occurs in individuals with a history of probable or confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others which generally have an impact on everyday functioning. Symptoms may be new onset, following initial recovery from an acute COVID-19 episode, or persist from the initial illness. Symptoms may also fluctuate or relapse over time".

Inclusion Criteria:

* Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.
* Participant is a resident in Alberta, Canada.
* Participant had confirmed COVID-19 via a positive molecular or antigen test within the past 18 months. Alternatively, in the case of a lack of access to testing, evidence of infection including close contact with a confirmed case of COVID-19 or being linked with a COVID-19 outbreak, or an acute illness including the core symptoms of COVID-19 (cough, fever, shortness of breath, runny nose, sore throat, loss of taste or smell).
* Experiencing symptoms and ongoing functional limitations that have persisted for ≥3 months (from the first positive test/known exposure date/symptom onset). At least one self-reported symptom is fatigue, shortness of breath, cognitive dysfunction or activity intolerance, and
* Post-COVID-19 Functional Status Scale (PFSS) score of ≥2 \[22,23\].
* Symptoms developed or substantially worsened during or after the acute infection (i.e., they are not explained by a co-occurring condition that pre-dates COVID-19).

Exclusion Criteria:

* Participant does not have access to a smart phone or computer (desktop, laptop, or tablet).
* Receiving ongoing physical therapy via the Workers' Compensation Board.
* Participants are currently participating in a regular rehabilitation program such as the Alberta Health Services (AHS) "Breathe Easy Program - Pulmonary Rehabilitation" or "Supervised Transitional Exercise Program (STEP) Forward - program." Previous participation or being on the waitlist for these services are not exclusion criteria.
* A peripheral oxygen saturation \<92% at rest on room air, syncope at rest or on exertion, and any other significant medical complexity that might require medical attention based on clinical judgement.
* A diagnosis of a post-viral syndrome including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) that pre-dates COVID-19.

Primary outcomes:
measure: Self-efficacy to manage symptoms
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Self-efficacy to manage daily activities
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Self-efficacy to manage emotions
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
Secondary outcomes:
measure: Self-efficacy to manage symptoms
timeFrame: 3-month follow-up (Change from Baseline)
measure: Self-efficacy to manage daily activities
timeFrame: 3-month follow-up (Change from Baseline)
measure: Self-efficacy to manage emotions
timeFrame: 3-month follow-up (Change from Baseline)
measure: Fatigue severity (FACIT-F)
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Fatigue severity (FACIT-F)
timeFrame: 3-month follow-up (Change from Baseline)
measure: Medical Research Council (MRC) breathlessness scale grade
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Medical Research Council (MRC) breathlessness scale grade
timeFrame: 3-month follow-up (Change from Baseline)
measure: Post-COVID-19 Functional Scale (PCFS) grade
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Post-COVID-19 Functional Scale (PCFS) grade
timeFrame: 3-month follow-up (Change from Baseline)
measure: Recovery grade
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Recovery grade
timeFrame: 3-month follow-up (Change from Baseline)
measure: Physical functioning subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Physical functioning subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Role limitations due to physical health subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Role limitations due to physical health subscale score
timeFrame: 3-month follow-up (Change from Baseline).
measure: Role limitations due to emotional problems subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Role limitations due to emotional problems subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Emotional well-being subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Emotional well-being subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Social functioning subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Social functioning subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Energy/fatigue subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Energy/fatigue subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Pain subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Pain subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: General health subscale score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: General health subscale score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Physical component score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Physical component score
timeFrame: 3-month follow-up (Change from Baseline)
measure: Mental component score
timeFrame: Week 9 i.e. post-intervention (Change from Baseline)
measure: Mental component score
timeFrame: 3-month follow-up (Change from Baseline)
Other outcomes:
measure: Attendance
timeFrame: The 8-week intervention.
measure: Safety (the number and nature of adverse events)
timeFrame: The 8-week intervention.
measure: Tolerability (change in momentary rating of fatigue)
timeFrame: All sessions in the 8-week intervention.
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: