Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baker Heart and Diabetes Institute | OTHER |
| Ochre Health | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 Smartphone Cardiac Rehabilitation, Assisted self-Management (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. |
|
| Usual Care | No Intervention | Participants receive a personalised risk factor report following baseline assessment and a cardiology review, and are encouraged to discuss findings and recommended lifestyle changes with their GP. No additional study interventions are provided. All medical management remains at the discretion of the participant's usual care team. Participants whose exercise capacity remains abnormal at 12 months are offered the opportunity to cross over to the intervention arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERCEIVE-Outreach Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 6-min walk distance (6MWD) at 6 months | 6MWD in metres | From enrolment until the 6-month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6MWD at 12 and 24 months | 6MWD in metres | From enrolment until the 12- and 24-month visits, each. |
| Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months | Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Huynh, PhD | Contact | +61 03 8532 1833 | quan.huynh@utas.edu.au; quan.huynh@baker.edu.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menzies Insititute for Medical Research | Recruiting | Hobart | Tasmania | 7009 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From enrolment until the 12- and 24-month visits, each. |
| Patient Health Questionnaire (PHQ)-9 at 12 & 24 months; | Range 0 (less depressive symptoms) to 27 (more depressive symptoms) | From enrolment until the 12- and 24-month visits, each. |
| International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months | Range 0 to over 20,000 MET-minutes/week;
| From enrolment until the 12- and 24-month visits, each. |
| Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) | 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. | From enrolment until the 12- and 24-month visits, each. |
| Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months | 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. | From enrolment until the 12- and 24-month visits, each. |
| Incidence of cardiovascular over the 24-month trial period | 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. | From enrolment until the 12- and 24-month visits, each. |
| Incidence of all-cause hospitalisation over the 24-month trial period | All-cause hospitalisation will be assessed as the number of participants admitted to hospital for any cause during the follow-up period. | From enrolment until the 12- and 24-month visits, each. |
| Incremental cost-effectiveness ratio of the care model | 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. | From enrolment until the 12- and 24-month visits, each. |
| Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise | 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. | From enrolment until the 12- and 24-month visits, each. |
| Change in peak oxygen consumption (peakVO2) at 12 and 24 months | Measured in mL/kg/min | From enrolment until the 12- and 24-month visits, each. |
| Baker Heart and Diabetes Institute | Not yet recruiting | Melbourne | Victoria | 3004 | Australia |
|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |