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Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Menzies Insititute for Medical Research
RECRUITING
Hobart
Baker Heart and Diabetes Institute
NOT_YET_RECRUITING
Melbourne
Contact Information
Primary
Quan Huynh, PhD
quan.huynh@utas.edu.au; quan.huynh@baker.edu.au
+61 03 8532 1833
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 577
Treatments
Experimental: 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 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.
No_intervention: Usual Care
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ochre Health, Baker Heart and Diabetes Institute
Leads: University of Tasmania

This content was sourced from clinicaltrials.gov

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