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

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

Overview

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.

Interventions

• Other PERCEIVE-Outreach 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 w

Primary outcome measures

• Changes in 6-min walk distance (6MWD) at 6 months [Time frame: From enrolment until the 6-month visit]

Secondary outcome measures (11)

• 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.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Australia · 2 centers

• Menzies Insititute for Medical Research — Hobart
• Baker Heart and Diabetes Institute — Melbourne

Identifiers

NCT: NCT07661862 · 49-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗