PERCEIVE-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID
2026年6月16日 更新者：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:
- 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.
調査の概要
研究の種類
介入
入学 (推定)
577
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Quan Huynh, PhD
- 電話番号：+61 03 8532 1833
- メール：quan.huynh@utas.edu.au; quan.huynh@baker.edu.au
研究場所
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Tasmania
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Hobart、Tasmania、オーストラリア、7009
- 募集
- Menzies Insititute for Medical Research
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コンタクト：
- Quan Huynh, PhD
- 電話番号：+61 03 8532 1833
- メール：quan.huynh@utas.edu.au
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Victoria
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Melbourne、Victoria、オーストラリア、3004
- まだ募集していません
- Baker Heart and Diabetes Institute
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コンタクト：
- Tom Marwick, MD, MPH, PhD
- 電話番号：+61385321550
- メール：tom.marwick@baker.edu.au
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in 6-min walk distance (6MWD) at 6 months
時間枠：From enrolment until the 6-month visit
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6MWD in metres
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From enrolment until the 6-month visit
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in 6MWD at 12 and 24 months
時間枠：From enrolment until the 12- and 24-month visits, each.
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6MWD in metres
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From enrolment until the 12- and 24-month visits, each.
|
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Change in Assessment of Quality of Life (AQoL) 8D at 12 & 24 months
時間枠：From enrolment until the 12- and 24-month visits, each.
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Publicly accessible Australian utility score (online); range 0.06 (worse) to 1.00 (better)
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From enrolment until the 12- and 24-month visits, each.
|
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Patient Health Questionnaire (PHQ)-9 at 12 & 24 months;
時間枠：From enrolment until the 12- and 24-month visits, each.
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Range 0 (less depressive symptoms) to 27 (more depressive symptoms)
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From enrolment until the 12- and 24-month visits, each.
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International Physical Activity Questionnaire (IPAQ) short form at 12 & 24 months
時間枠：From enrolment until the 12- and 24-month visits, each.
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Range 0 to over 20,000 MET-minutes/week;
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From enrolment until the 12- and 24-month visits, each.
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Sedentary-break adherence measured by Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM)
時間枠：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.
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From enrolment until the 12- and 24-month visits, each.
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Change in cardiac function measured by transthoracic echocardiography at 12 & 24 months
時間枠：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.
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From enrolment until the 12- and 24-month visits, each.
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Incidence of cardiovascular over the 24-month trial period
時間枠：From enrolment until the 12- and 24-month visits, each.
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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.
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From enrolment until the 12- and 24-month visits, each.
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Incidence of all-cause hospitalisation over the 24-month trial period
時間枠：From enrolment until the 12- and 24-month visits, each.
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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.
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Incremental cost-effectiveness ratio of the care model
時間枠：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.
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From enrolment until the 12- and 24-month visits, each.
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Post-exertional malaise measured by the DePaul Symptom Questionnaire - Post-Exertional Malaise
時間枠：From enrolment until the 12- and 24-month visits, each.
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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.
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From enrolment until the 12- and 24-month visits, each.
|
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Change in peak oxygen consumption (peakVO2) at 12 and 24 months
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月1日
一次修了 (推定)
2029年4月1日
研究の完了 (推定)
2029年4月1日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 49-26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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