BREATHE: Virtual Self-management for Long COVID-19

COVID-19 Clinical Trial

Official title:

BREATHE: A Mixed-methods Evaluation of a Virtual Self-management Program for People Living With Long COVID-19 in Alberta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107440
• Other study ID #: REB21-1359
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: January 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 13, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• BREATHE
A 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attendance	The number of virtual sessions attended expressed as a percentage of those scheduled (16).	The 8-week intervention.
Other	Safety (the number and nature of adverse events)	Serious adverse events (defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity) will be reported. Participants will be instructed to report adverse events that occur during or outside of intervention sessions. Adverse events will also be described as severe exacerbation in any symptom that results in further disability or further disruption in the ability to conduct normal life functions (beyond existing disability or disruptions due to long COVID).	The 8-week intervention.
Other	Tolerability (change in momentary rating of fatigue)	0-10 numerical rating of fatigue (ROF) scale, measured pre-post each virtual session.	All sessions in the 8-week intervention.
Primary	Self-efficacy to manage symptoms	Total score on the 8-item short form, from the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.	Week 9 i.e. post-intervention (Change from Baseline)
Primary	Self-efficacy to manage daily activities	Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank	Week 9 i.e. post-intervention (Change from Baseline)
Primary	Self-efficacy to manage emotions	Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Self-efficacy to manage symptoms	Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank. These PROMIS item banks include all include 8 items that are used to determine a T-score. A T-score of 50 represents the average of people managing chronic health conditions, and ten points is one standard deviation.	3-month follow-up (Change from Baseline)
Secondary	Self-efficacy to manage daily activities	Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank	3-month follow-up (Change from Baseline)
Secondary	Self-efficacy to manage emotions	Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank	3-month follow-up (Change from Baseline)
Secondary	Fatigue severity (FACIT-F)	Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Fatigue severity (FACIT-F)	Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale	3-month follow-up (Change from Baseline)
Secondary	Medical Research Council (MRC) breathlessness scale grade	Modified according to recommendations for core outcomes for COVID-19 research.	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Medical Research Council (MRC) breathlessness scale grade	Modified according to recommendations for core outcomes for COVID-19 research.	3-month follow-up (Change from Baseline)
Secondary	Post-COVID-19 Functional Scale (PCFS) grade	Post-COVID-19 Functional Scale (PCFS)	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Post-COVID-19 Functional Scale (PCFS) grade	Post-COVID-19 Functional Scale (PCFS)	3-month follow-up (Change from Baseline)
Secondary	Recovery grade	Recommended core outcome measure	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Recovery grade	Recommended core outcome measure	3-month follow-up (Change from Baseline)
Secondary	Physical functioning subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Physical functioning subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Role limitations due to physical health subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Role limitations due to physical health subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline).
Secondary	Role limitations due to emotional problems subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Role limitations due to emotional problems subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Emotional well-being subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Emotional well-being subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Social functioning subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Social functioning subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Energy/fatigue subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Energy/fatigue subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Pain subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Pain subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	General health subscale score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	General health subscale score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Physical component score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Physical component score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)
Secondary	Mental component score	36-Item Short-Form Health Survey	Week 9 i.e. post-intervention (Change from Baseline)
Secondary	Mental component score	36-Item Short-Form Health Survey	3-month follow-up (Change from Baseline)