COVID-19NCT05107440
BREATHE: Virtual Self-management for Long COVID-19
A study testing BREATHE in people with COVID-19, run by University of Calgary at 1 site in Canada.
Trial summary
A mixed-methods evaluation of a virtual self-management program for people living with long COVID in Alberta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- BREATHE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2022to 13 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BREATHE: A Mixed-methods Evaluation of a Virtual Self-management Program for People Living With Long COVID-19 in Alberta
A mixed-methods evaluation of a virtual self-management program for people living with long COVID in Alberta.
Read the 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.
- Conditions
- COVID-19
- Being tested
- BREATHE
- Keywords
- Long COVID, Post COVID-19 condition, Post-acute COVID-19 syndrome
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE | Experimental | This is an eight-week intervention involving two sessions per week, hosted virtually on Zoom. The main session is scheduled to last 60 min and the session hosts remain online for an additional 15 minutes to answer individual questions on the management of symptoms and activities that have not been addressed during the main session. The content was developed based on clinical experience, best available evidence for the management of specific symptoms (chronic fatigue, post-exertional malaise, breathing discomfort) in other conditions, including post-viral syndromes, and the current understanding and recommendations for rehabilitation of people living with long COVID. Long COVID can be isolating, and challenges often interfere with everyday lifestyle and socialization. The investigators have incorporated breakout rooms (where the group is divided into two smaller groups based on current activity limitations) to include elements of peer support. Receives: Other: BREATHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 9 i.e. post-intervention (Change from Baseline)
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
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Self-efficacy to manage emotions
Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Secondary outcomes (31)
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.
Measured: 3-month follow-up (Change from Baseline)
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
Measured: 3-month follow-up (Change from Baseline)
Self-efficacy to manage emotions
Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank
Measured: 3-month follow-up (Change from Baseline)
Fatigue severity (FACIT-F)
Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Fatigue severity (FACIT-F)
Total score on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Measured: 3-month follow-up (Change from Baseline)
Medical Research Council (MRC) breathlessness scale grade
Modified according to recommendations for core outcomes for COVID-19 research.
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Medical Research Council (MRC) breathlessness scale grade
Modified according to recommendations for core outcomes for COVID-19 research.
Measured: 3-month follow-up (Change from Baseline)
Post-COVID-19 Functional Scale (PCFS) grade
Post-COVID-19 Functional Scale (PCFS)
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Post-COVID-19 Functional Scale (PCFS) grade
Post-COVID-19 Functional Scale (PCFS)
Measured: 3-month follow-up (Change from Baseline)
Recovery grade
Recommended core outcome measure
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Recovery grade
Recommended core outcome measure
Measured: 3-month follow-up (Change from Baseline)
Physical functioning subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Physical functioning subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Role limitations due to physical health subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Role limitations due to physical health subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline).
Role limitations due to emotional problems subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Role limitations due to emotional problems subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Emotional well-being subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Emotional well-being subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Social functioning subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Social functioning subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Energy/fatigue subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Energy/fatigue subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Pain subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Pain subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
General health subscale score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
General health subscale score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Physical component score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Physical component score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Mental component score
36-Item Short-Form Health Survey
Measured: Week 9 i.e. post-intervention (Change from Baseline)
Mental component score
36-Item Short-Form Health Survey
Measured: 3-month follow-up (Change from Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start3 Jan 2022
- Primary completion20 Jun 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Culos-Reed, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107440
- Sponsor's protocol ID
- REB21-1359
- Status last verified
- Jan 2022
- First submitted
- 13 Oct 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set will be made available on the Open Science Framework. Participant information will only be presented in aggregate in manuscripts, and direct and indirect identifiers will be removed from the open dataset to ensure participant anonymity.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE: A Mixed-methods Evaluation of a Virtual Self-management Program for People Living With Long COVID-19 in Alberta
- ClinicalTrials.gov ID
- NCT05107440
- Acronym / sponsor ID
- REB21-1359
- Conditions
- COVID-19
- Keywords
- Long COVID, Post COVID-19 condition, Post-acute COVID-19 syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BREATHE | Experimental | Other: BREATHEThis is an eight-week intervention involving two sessions per week, hosted virtually on Zoom. The main session is scheduled to last 60 min and the session hosts remain online for an additional 15 minutes to answer individual questions on the management of symptoms and activities that have not been addressed during the main session. The content was developed based on clinical experience, best available evidence for the management of specific symptoms (chronic fatigue, post-exertional malaise, breathing discomfort) in other conditions, including post-viral syndromes, and the current understanding and recommendations for rehabilitation of people living with long COVID. Long COVID can be isolating, and challenges often interfere with everyday lifestyle and socialization. The investigators have incorporated breakout rooms (where the group is divided into two smaller groups based on current activity limitations) to include elements of peer support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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].
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHEA 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. | Other | BREATHE |
Primary outcome
Self-efficacy to manage symptoms
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
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.
Self-efficacy to manage daily activities
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank
Self-efficacy to manage emotions
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Total score on the 8-item short form, from the PROMIS Self-efficacy for Managing Chronic Conditions item bank
31 secondary outcomes
Self-efficacy to manage symptoms
Time frame: 3-month follow-up (Change from Baseline)
Self-efficacy to manage daily activities
Time frame: 3-month follow-up (Change from Baseline)
Self-efficacy to manage emotions
Time frame: 3-month follow-up (Change from Baseline)
Fatigue severity (FACIT-F)
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Fatigue severity (FACIT-F)
Time frame: 3-month follow-up (Change from Baseline)
Medical Research Council (MRC) breathlessness scale grade
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Medical Research Council (MRC) breathlessness scale grade
Time frame: 3-month follow-up (Change from Baseline)
Post-COVID-19 Functional Scale (PCFS) grade
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Post-COVID-19 Functional Scale (PCFS) grade
Time frame: 3-month follow-up (Change from Baseline)
Recovery grade
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Recovery grade
Time frame: 3-month follow-up (Change from Baseline)
Physical functioning subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Physical functioning subscale score
Time frame: 3-month follow-up (Change from Baseline)
Role limitations due to physical health subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Role limitations due to physical health subscale score
Time frame: 3-month follow-up (Change from Baseline).
Role limitations due to emotional problems subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Role limitations due to emotional problems subscale score
Time frame: 3-month follow-up (Change from Baseline)
Emotional well-being subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Emotional well-being subscale score
Time frame: 3-month follow-up (Change from Baseline)
Social functioning subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Social functioning subscale score
Time frame: 3-month follow-up (Change from Baseline)
Energy/fatigue subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Energy/fatigue subscale score
Time frame: 3-month follow-up (Change from Baseline)
Pain subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Pain subscale score
Time frame: 3-month follow-up (Change from Baseline)
General health subscale score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
General health subscale score
Time frame: 3-month follow-up (Change from Baseline)
Physical component score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Physical component score
Time frame: 3-month follow-up (Change from Baseline)
Mental component score
Time frame: Week 9 i.e. post-intervention (Change from Baseline)
Mental component score
Time frame: 3-month follow-up (Change from Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Yes. A de-identified data set will be made available on the Open Science Framework. Participant information will only be presented in aggregate in manuscripts, and direct and indirect identifiers will be removed from the open dataset to ensure participant anonymity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Culos-Reed, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE in people with COVID-19, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy to manage symptoms (time frame: Week 9 i.e. post-intervention (Change from Baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.