BREATHE: Virtual Self-management for Long COVID-19

NCT05107440 | Completed

• 1 other identifier: REB21-1359
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

Long COVID; Post COVID-19 condition; Post-acute COVID-19 syndrome

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (31)

• Self-efficacy to manage symptoms

  3-month follow-up (Change from Baseline)

• Self-efficacy to manage daily activities

  3-month follow-up (Change from Baseline)

• Self-efficacy to manage emotions

  3-month follow-up (Change from Baseline)

• Fatigue severity (FACIT-F)

  Week 9 i.e. post-intervention (Change from Baseline)

• Fatigue severity (FACIT-F)

  3-month follow-up (Change from Baseline)

Other Outcomes (3)

• Attendance

  The 8-week intervention.

• Safety (the number and nature of adverse events)

  The 8-week intervention.

• Tolerability (change in momentary rating of fatigue)

  All sessions in the 8-week intervention.

Study Arms (1)

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.

Other: BREATHE

Interventions

BREATHE OTHER

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.

BREATHE

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Participant does not have access to a smart phone or computer (desktop, laptop, or tablet).
• Receiving ongoing physical therapy via the Workers' Compensation Board.
• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Beclomethasone

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; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Nicole Culos-Reed, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 4, 2021
• Study Start: January 3, 2022
• Primary Completion: June 20, 2022
• Study Completion: October 13, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The de-identified data will be posted when the manuscript is uploaded to a scholarly archiving repository.
• Access Criteria: Open access to a de-identified dataset.

Locations

CA (1)