Long COVIDNCT07661862
PERCEIVE-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID
A study testing PERCEIVE-Outreach Disease Management Program in people with Long COVID, run by University of Tasmania at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- PERCEIVE-Outreach Disease Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Menzies Insititute for Medical Research
Hobart, Tasmania, 7009
Quan Huynh, PhD, +61 03 8532 1833, quan.huynh@utas.edu.au
- Not yet recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
Tom Marwick, MD, MPH, PhD, +61385321550, tom.marwick@baker.edu.au
About this study
Official title: Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID
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:
Read more
- Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels.
- Clinical review: A thorough check of heart and lung health conducted remotely via telehealth.
- 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.
- Conditions
- Long COVID
- Being tested
- PERCEIVE-Outreach Disease Management Program
- Keywords
- Long COVID, Exercise, PERCEIVE-Outreach, PERCEIVE, Australia, Rural Health, Cardiovascular
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERCEIVE-Outreach Disease Management ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiorespiratory and Psychiatric Tele-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. Receives: Other: PERCEIVE-Outreach Disease Management Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 6-min walk distance (6MWD) at 6 months
6MWD in metres
Measured: From enrolment until the 6-month visit
Secondary outcomes (11)
Change in 6MWD at 12 and 24 months
6MWD in metres
Measured: 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)
Measured: 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)
Measured: 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;
- Low: Under 600 MET-minutes/week
- Moderate: 600 to 2,999 MET-minutes/week
- High: 3,000+ MET-minutes/week
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrolment until the 12- and 24-month visits, each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 577 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tasmania
- Sponsor type
- University, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Ochre Health
- Responsible party
- Principal investigator, Quan Huynh, University of Tasmania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661862
- Sponsor's protocol ID
- 49-26
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID
- ClinicalTrials.gov ID
- NCT07661862
- Acronym / sponsor ID
- 49-26
- Conditions
- Long COVID
- Keywords
- Long COVID, Exercise, PERCEIVE-Outreach, PERCEIVE, Australia, Rural Health, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 577 participants (estimated)
- Lead sponsor
- University of TasmaniaUniversity, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Ochre Health
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 22 Jun 2026 (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.
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:
- Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels.
- Clinical review: A thorough check of heart and lung health conducted remotely via telehealth.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiorespiratory and Psychiatric Tele-Intervention | Experimental | Other: PERCEIVE-Outreach Disease Management ProgramParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| PERCEIVE-Outreach Disease Management ProgramParticipants 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. | Other | Cardiorespiratory and Psychiatric Tele-Intervention |
Primary outcome
Changes in 6-min walk distance (6MWD) at 6 months
Time frame: From enrolment until the 6-month visit
6MWD in metres
11 secondary outcomes
Change in 6MWD at 12 and 24 months
Time frame: From enrolment until the 12- and 24-month visits, each.
Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months
Time frame: From enrolment until the 12- and 24-month visits, each.
Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;
Time frame: From enrolment until the 12- and 24-month visits, each.
International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months
Time frame: From enrolment until the 12- and 24-month visits, each.
Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)
Time frame: From enrolment until the 12- and 24-month visits, each.
Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months
Time frame: From enrolment until the 12- and 24-month visits, each.
Incidence of cardiovascular over the 24-month trial period
Time frame: From enrolment until the 12- and 24-month visits, each.
Incidence of all-cause hospitalisation over the 24-month trial period
Time frame: From enrolment until the 12- and 24-month visits, each.
Incremental cost-effectiveness ratio of the care model
Time frame: From enrolment until the 12- and 24-month visits, each.
Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise
Time frame: From enrolment until the 12- and 24-month visits, each.
Change in peak oxygen consumption (peakVO2) at 12 and 24 months
Time frame: From enrolment until the 12- and 24-month visits, each.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERCEIVE-Outreach Disease Management Program in people with Long COVID, run by University of Tasmania at 2 sites in Australia.
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 6 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Huynh, PhD (+61 03 8532 1833, quan.huynh@utas.edu.au; quan.huynh@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 6-min walk distance (6MWD) at 6 months (time frame: From enrolment until the 6-month visit). 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 6 Oct 2026.