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

ConditionLong COVID
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Tasmania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PERCEIVE-Outreach Disease Management Program

    Other 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.

Treatment groups

577 Participants
are divided into 2 treatment groups
Group A: Cardiorespiratory and Psychiatric Tele-InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

6MWD in metres

Time frame
From enrolment until the 6-month visit

Secondary outcomes

1

Change in 6MWD at 12 and 24 months

6MWD in metres

Time frame
From enrolment until the 12- and 24-month visits, each.
2

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)

Time frame
From enrolment until the 12- and 24-month visits, each.
3

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

Range 0 (less depressive symptoms) to 27 (more depressive symptoms)

Time frame
From enrolment until the 12- and 24-month visits, each.
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tasmania

Lead sponsor

Baker Heart and Diabetes Institute

Collaborator

Ochre Health

Collaborator