PERCEIVE-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID

NCT07661862 | Recruiting

• 1 other identifier: 49-26
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 2

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. 1.Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels.
2. 2.Clinical review: A thorough check of heart and lung health conducted remotely via telehealth.
3. 3.Personalised exercise program: A tailored program to help improve fitness and reduce time spent sitting, delivered entirely via telehealth.

Conditions

Long COVID

Keywords

Long COVID; Exercise; PERCEIVE-Outreach; PERCEIVE; Australia; Rural Health; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Changes in 6-min walk distance (6MWD) at 6 months

  6MWD in metres

  From enrolment until the 6-month visit

Secondary Outcomes (11)

• Change in 6MWD at 12 and 24 months

  From enrolment until the 12- and 24-month visits, each.

• Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months

  From enrolment until the 12- and 24-month visits, each.

• Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;

  From enrolment until the 12- and 24-month visits, each.

• International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months

  From enrolment until the 12- and 24-month visits, each.

• Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)

  From enrolment until the 12- and 24-month visits, each.

Study Arms (2)

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.

Other: PERCEIVE-Outreach Intervention

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tasmania: lead
• Baker Heart and Diabetes Institute: collaborator
• Ochre Health: collaborator

Study Sites (2)

Menzies Insititute for Medical Research

Hobart, Tasmania, 7009, Australia

RECRUITING

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

COVID-19; 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; Behavior

Central Study Contacts

Quan Huynh, PhD

CONTACT

+61 03 8532 1833; quan.huynh@utas.edu.au; quan.huynh@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)