Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 577
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PERCEIVE-Outreach Intervention (Other)
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.
研究者
Quan Huynh
Associate Professor
University of Tasmania