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

2026년 6월 16일 업데이트: Quan Huynh, University of Tasmania

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

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

577

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 호주
    • Tasmania
      • Hobart, Tasmania, 호주, 7009
        • 모병
        • Menzies Insititute for Medical Research
        • 연락하다:
    • Victoria
      • Melbourne, Victoria, 호주, 3004
        • 아직 모집하지 않음
        • Baker Heart and Diabetes Institute
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes in 6-min walk distance (6MWD) at 6 months
기간: From enrolment until the 6-month visit
6MWD in metres
From enrolment until the 6-month visit

2차 결과 측정

결과 측정
측정값 설명
기간
Change in 6MWD at 12 and 24 months
기간: From enrolment until the 12- and 24-month visits, each.
6MWD in metres
From enrolment until the 12- and 24-month visits, each.
Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months
기간: From enrolment until the 12- and 24-month visits, each.
Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better)
From enrolment until the 12- and 24-month visits, each.
Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;
기간: From enrolment until the 12- and 24-month visits, each.
Range 0 (less depressive symptoms) to 27 (more depressive symptoms)
From enrolment until the 12- and 24-month visits, each.
International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months
기간: From enrolment until the 12- and 24-month visits, each.

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
From enrolment until the 12- and 24-month visits, each.
Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)
기간: From enrolment until the 12- and 24-month visits, each.
Sedentary-break adherence will be assessed using SCRAM-recorded activity-break completion, including the number of 3-minute sitting breaks completed per day and total daily activity-break duration in minutes/day. The intervention target is 30 minutes/day of activity breaks, equivalent to 10 breaks/day. Higher values indicate greater adherence to sedentary-time interruption.
From enrolment until the 12- and 24-month visits, each.
Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months
기간: From enrolment until the 12- and 24-month visits, each.
Left ventricular dysfunction will be assessed using resting 2-dimensional and Doppler transthoracic echocardiography. Left ventricular dysfunction will be defined as any of the following: left ventricular ejection fraction <40%, reduced left ventricular global longitudinal strain ≤16%, diastolic dysfunction, or left ventricular hypertrophy. Diastolic dysfunction will be assessed using mitral inflow velocities, E/A ratio, mitral annular e' velocities, E/e' ratio, left atrial volume index, and tricuspid regurgitation velocity. Left ventricular hypertrophy will be defined as left ventricular mass index >95 g/m² in women and >115 g/m² in men. The outcome will be reported as the number of participants meeting criteria for left ventricular dysfunction at follow-up and/or developing new left ventricular dysfunction from baseline.
From enrolment until the 12- and 24-month visits, each.
Incidence of cardiovascular over the 24-month trial period
기간: From enrolment until the 12- and 24-month visits, each.
Cardiovascular hospitalisation will be assessed as the number of participants admitted to hospital for a cardiovascular cause, including heart failure, acute coronary syndrome, arrhythmia, stroke, venous thromboembolism, or other cardiovascular events.
From enrolment until the 12- and 24-month visits, each.
Incidence of all-cause hospitalisation over the 24-month trial period
기간: From enrolment until the 12- and 24-month visits, each.
All-cause hospitalisation will be assessed as the number of participants admitted to hospital for any cause during the follow-up period.
From enrolment until the 12- and 24-month visits, each.
Incremental cost-effectiveness ratio of the care model
기간: From enrolment until the 12- and 24-month visits, each.
Cost-effectiveness will be assessed using the incremental cost-effectiveness ratio, calculated as the difference in costs between study groups divided by the difference in health outcomes. Costs will be reported in Australian dollars. Health outcomes may include quality-adjusted life years derived from health-related quality-of-life data. Lower incremental cost per quality-adjusted life year gained indicates greater cost-effectiveness.
From enrolment until the 12- and 24-month visits, each.
Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise
기간: From enrolment until the 12- and 24-month visits, each.
Post-exertional malaise will be assessed using the DePaul Symptom Questionnaire - Post-Exertional Malaise. Frequency and severity items are scored on 5-point Likert scales from 0 to 4, with higher scores indicating more frequent or more severe post-exertional malaise. Prevalence of post-exertional malaise and change in symptom burden from baseline will be reported.
From enrolment until the 12- and 24-month visits, each.
Change in peak oxygen consumption (peakVO2) at 12 and 24 months
기간: From enrolment until the 12- and 24-month visits, each.
Measured in mL/kg/min
From enrolment until the 12- and 24-month visits, each.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Tasmania

협력자

Baker Heart and Diabetes Institute
Ochre Health

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2029년 4월 1일

연구 완료 (추정된)

2029년 4월 1일

연구 등록 날짜

최초 제출

2026년 5월 26일

QC 기준을 충족하는 최초 제출

2026년 6월 16일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 16일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 49-26

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다