Long COVID
Conditions
Keywords
Long COVID, Exercise, PERCEIVE-Outreach, PERCEIVE, Australia, Rural Health, Cardiovascular
Brief summary
Some people who had COVID-19 continue to have symptoms for weeks, months, or even years after their infection. This is often called "Long COVID" or Post-Acute Sequelae of SARS-CoV-2 (PASC). For some people, Long COVID can affect the heart and lungs, making it harder to exercise or carry out daily activities. It can also affect mental health and quality of life. This study is testing a new care model called PERCEIVE-Outreach, designed to help people living with Long COVID who may have ongoing heart or lung problems. The model involves three parts: 1. Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels. 2. Clinical review: A thorough check of heart and lung health conducted remotely via telehealth. 3. Personalised exercise program: A tailored program to help improve fitness and reduce time spent sitting, delivered entirely via telehealth. The main thing this study is measuring is whether participants can walk further after 6 months compared to when they started (measured using a 6-minute walk test), which correlates well with an individuals ability to complete normal daily functions. The study will also look at quality of life, mental health, physical activity, heart function, and hospital visits over 2 years. The study is designed with input from patients and healthcare providers to ensure it meets real-world needs. All care is delivered remotely, meaning participants can take part from home anywhere in Australia.
Interventions
OTHERPERCEIVE-Outreach Intervention
Participants receive a comprehensive, remotely delivered care program in addition to usual care. This includes: (1) medication review and optimisation for heart protection where appropriate; (2) personalised mental health support from a psychologist; (3) telehealth coaching from cardiac nurses; and (4) a 24-week personalised exercise program delivered via the SCRAM digital platform, using a Polar wearable sensor for real-time monitoring. The exercise program includes a 12-week supervised phase with live physiologist support, followed by a 12-week self-managed phase with app-based guidance. Participants also work to reduce sitting time through regular short activity breaks prompted by the app.
Sponsors
University of Tasmania
Baker Heart and Diabetes Institute
Ochre Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged forty years or older * Impaired estimated functional capacity using DASI as proxy (defined by age-normative metabolic equivalent of tasks \[METs\]) * History of COVID-19 (stratified by hospital admission) * Currently symptomatic with fatigue, dyspnoea or chest pain symptoms * Medicare eligibility * Ability and willingness to provide written informed consent to participate in the study. The patient will need to be able to communicate fluently with the investigator. The investigator will need to be satisfied that the patient understands the study by having them explain the study plan back to the investigator.
Exclusion criteria
* Unable to provide written informed consent to participate in this study * Participating in another research trial where randomized treatment would be unacceptable * Mobility impairment that would impact participants' ability to perform exercise * History of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) * Known valvular stenosis or regurgitation of \>moderate severity, history of previous heart failure (baseline New York Heart Association \[NYHA\] \>2) * Oncologic (or other) life expectancy \<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in 6-min walk distance (6MWD) at 6 months | From enrolment until the 6-month visit | 6MWD in metres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6MWD at 12 and 24 months | From enrolment until the 12- and 24-month visits, each. | 6MWD in metres |
| Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months | From enrolment until the 12- and 24-month visits, each. | Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better) |
| Patient Health Questionnaire (PHQ)-9 at 12 & 24 months; | From enrolment until the 12- and 24-month visits, each. | Range 0 (less depressive symptoms) to 27 (more depressive symptoms) |
| International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months | From enrolment until the 12- and 24-month visits, each. | Range 0 to over 20,000 MET-minutes/week; * Low: Under 600 MET-minutes/week * Moderate: 600 to 2,999 MET-minutes/week * High: 3,000+ MET-minutes/week |
| Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) | From enrolment until the 12- and 24-month visits, each. | Sedentary-break adherence will be assessed using SCRAM-recorded activity-break completion, including the number of 3-minute sitting breaks completed per day and total daily activity-break duration in minutes/day. The intervention target is 30 minutes/day of activity breaks, equivalent to 10 breaks/day. Higher values indicate greater adherence to sedentary-time interruption. |
| Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months | From enrolment until the 12- and 24-month visits, each. | Left ventricular dysfunction will be assessed using resting 2-dimensional and Doppler transthoracic echocardiography. Left ventricular dysfunction will be defined as any of the following: left ventricular ejection fraction \<40%, reduced left ventricular global longitudinal strain ≤16%, diastolic dysfunction, or left ventricular hypertrophy. Diastolic dysfunction will be assessed using mitral inflow velocities, E/A ratio, mitral annular e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity. Left ventricular hypertrophy will be defined as left ventricular mass index \>95 g/m² in women and \>115 g/m² in men. The outcome will be reported as the number of participants meeting criteria for left ventricular dysfunction at follow-up and/or developing new left ventricular dysfunction from baseline. |
| Incidence of cardiovascular over the 24-month trial period | From enrolment until the 12- and 24-month visits, each. | Cardiovascular hospitalisation will be assessed as the number of participants admitted to hospital for a cardiovascular cause, including heart failure, acute coronary syndrome, arrhythmia, stroke, venous thromboembolism, or other cardiovascular events. |
| Incidence of all-cause hospitalisation over the 24-month trial period | From enrolment until the 12- and 24-month visits, each. | All-cause hospitalisation will be assessed as the number of participants admitted to hospital for any cause during the follow-up period. |
| Incremental cost-effectiveness ratio of the care model | From enrolment until the 12- and 24-month visits, each. | Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio, calculated as the difference in costs between study groups divided by the difference in health outcomes. Costs will be reported in Australian dollars. Health outcomes may include quality-adjusted life years derived from health-related quality-of-life data. Lower incremental cost per quality-adjusted life year gained indicates greater cost-effectiveness. |
| Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise | From enrolment until the 12- and 24-month visits, each. | Post-exertional malaise will be assessed using the DePaul Symptom Questionnaire - Post-Exertional Malaise. Frequency and severity items are scored on 5-point Likert scales from 0 to 4, with higher scores indicating more frequent or more severe post-exertional malaise. Prevalence of post-exertional malaise and change in symptom burden from baseline will be reported. |
| Change in peak oxygen consumption (peakVO2) at 12 and 24 months | From enrolment until the 12- and 24-month visits, each. | Measured in mL/kg/min |
Countries
Australia
Contacts
CONTACTQuan Huynh, PhD
Outcome results
None listed