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eCardiacRehab - a Hybrid Patient-Centered eHealth Programme (eCardiacRehab)

2026年6月18日 更新者：Haukeland University Hospital

eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions

The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all.

eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The primary objective is to test whether a hybrid CR programme (the eCardiacRehab) reduces the risk of CV death and CV related ED contacts, and improves quality of life compared to usual care in patients with CAD treated with PCI.

The secondary and exploratory objectives (planned for the main study) are:

  • To assess whether eCardiacRehab improves each of the components of the primary endpoint separately compared to usual care.
  • To assess clinical outcomes associated with eCardiacRehab in the following subgroups: age, sex (men vs. women), hypertension (yes vs. no), multimorbidity (yes vs. no), mental health challenges (yes vs. no).
  • To study whether eCardiacRehab reduces the total number of ED contacts compared to usual care.
  • To study whether eCardiacRehab reduces the risk of all-cause death compared to usual care.
  • To assess whether eCardiacRehab improves long-term medication adherence to cardiometabolic medications (e.g. antiplatelets, lipid lowering drugs, antihypertensive, and antidiabetics) in patients after PCI utilizing data from the Norwegian Prescribed Drug Registry, and by patients' self-report.
  • To assess whether participation in eCardiacRehab improves the total number of CV risk factors.
  • To assess whether participation in eCardiacRehab is non-inferior to conventional, in-person CR among the subset of usual care participants who attend standard place-based CR.

Other secondary objectives (for eCardiacRehab sub-studies) are:

  • To conduct a cost-utility study, from a societal and healthcare system perspective perspective; cost per QALY. Cost categories include i) the intervention; ii) inpatient/outpatient visits; iii) community-based healthcare; iv) medications; v) patient-borne costs and vi) production loss due to sick leave. Further, to estimate cost-effectiveness acceptability curves to estimate the probability that the intervention is cost-effective at different willingness to pay for a unit of the outcome measure.
  • To study whether eCardiacRehab affects the following patient-reported outcomes: quality of life, angina, anxiety, depression, sleep status, health literacy and eHealth literacy, frailty status, fatigue, continuity of care, and adherence to healthy lifestyle recommendations (physical activity, tobacco use, sleep, diet).
  • To study whether eCardiacRehab improves objectively measured cardiorespiratory fitness (VO2peak), intensity minutes (activity tracker) and self-reported physical activity and exercise.
  • To study whether eCardiacRehab improves body composition (visceral fat, muscle mass, body fat, BMI).
  • To study whether eCardiacRehab improves change in number of controlled risk factors.
  • To study whether eCardiacRehab improves low-density lipoproteins.

Exploratory objectives (for substudies):

  • To evaluate whether eCardiacRehab improves long-term medication adherence to cardiometabolic medications (e.g. antiplatelets, lipid lowering drugs, antihypertensive, and antidiabetics) in patients after PCI utilizing data from therapeutic drug monitoring (assessed by direct methods quantifying drug concentrations in blood).
  • To study differences in blood and urine biomarker concentrations between patients in the intervention and usual care group.
  • To study changes in blood pressure associated with digital cardiac rehabilitation.
  • To study cardiovascular mortality up to 10 years after index hospitalization.
  • To study cardiovascular ED contact up to 10 years after index hospitalization.
  • To study all-cause mortality up to 10 years after index hospitalization.
  • To study all-cause ED contact up to 10 years after index hospitalization.
  • To study the total number of ED contacts up to 10 years after index hospitalization.

Primary and secondary endpoints will be obtained by collection of self-reported data, clinical examination including blood and urine sample collection, and linkage to the following national registries: The Norwegian Registry of Invasive Cardiology, the Norwegian Population Registry, the Cause of Death Registry, the Norwegian Patient Registry, the Norwegian Myocardial Infarction Register, the Norwegian Prescription Database, the Norwegian Labour and Welfare Administration, Statistics Norway, the FD-Trygd database (social security micro data for research), the Control and payment of reimbursements to health service providers (KUHR) database and local hospital registries.

研究类型

介入性

注册 (估计的)

1000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number
  • With coronary artery disease after percutaneous coronary intervention
  • Living at home
  • Have internet available
  • Provide signed informed consent

Exclusion Criteria:

  • Patients with cognitive impairment that may interfere with the ability to comply with the study protocol
  • Severe aortic stenosis
  • Severe arrhythmias
  • Expected lifetime less than one year as determined by study personnel
  • Otherwise clinically unstable
  • Not fully revascularized
  • Awaits percutaneous coronary intervention or coronary artery bypass graft surgery
  • Inability to comply with the study protocol due to any physical disability, somatic disease, or mental problems as determined by study personnel

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：日常护理
无干预
有源比较器：eCardiacRehab
Digital cardiac rehabilitation
其他：eCardiacRehab
12-week digital cardiac rehabilitation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Composite clinical hierarchy of outcomes
大体时间：Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.
Composite clinical hierarchy of outcomes: Cardiovascular (CV) Death, CV Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (>24 hours), and quality of life.
Death and hospitalization 1 year after study inclusion. Quality of life after 3 months.

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular mortality
大体时间：1, 3, 5 years
Time to cardiovascular cause death from randomization.
1, 3, 5 years
Cardiovascular Emergency Department contact
大体时间：1, 3, 5 years
Time to Cardiovascular (CV) Emergency Department (ED) contact and home, CV ED and observation, CV ED and admission (>24 hours)
1, 3, 5 years
All-cause mortality
大体时间：1, 3, 5 years
Time to all-cause death from randomization
1, 3, 5 years
All-cause Emergency Department contact
大体时间：1, 3, 5 years
Emergency Department (ED) contact and home, ED and observation, ED and admission (>24 hours)
1, 3, 5 years
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)
大体时间：Pre-intervention, immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises 35 items specifically measuring seven different domains of health status and daily life challenges in individuals who have suffered a myocardial infarction: physical activity (12 items), insecurity (9 items), emotional reaction (4 items), dependency (3 items), diet (3 items), concerns over medication (2 items) and side effects (2 items). Respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.
Pre-intervention, immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Seattle Angina Questionnaire (SAQ- 7)
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, and 12-month follow-up.
SAQ-7 assesses patients' symptoms of chest pain, functioning, and quality of life through. The SAQ-7 is scored by transforming responses to seven items into three domains-Physical Limitation (PL), Angina Frequency (AF), and Quality of Life (QoL)-scaled from 0-100, where higher scores indicate better health. Items are coded 1-6 (worst to best), summed, and transformed. A total summary score is the average of these three domains
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, and 12-month follow-up.
RAND-12
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises 12 items with 3 to 5 response levels. It generates two health indices: mental and physical health. A score of 50 represents the average US population, while scores above or below indicate better or worse health, respectively.
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
WHOQOL-BREF
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises one global item on overall quality of life scored on a 1-5 Likert scale, ranging from "Very poor/dissatisfied" (1) to "Very good/satisfied" (5)
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The my experience of taking medicines (MYMEDS) questionnaire
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises 16 items and is a self-reporting tool for identifying modifiable adherence barriers among individuals prescribed post-myocardial infarction secondary prevention medicines in clinical practice. The questionnaire uses a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree) for sections 2-5, which focus on understanding, concerns, practical barriers, and routine. Adherence Assessment (Section 6): A 5-point Likert scale is used to assess adherence to individual secondary prevention medicines over the past month (e.g., all of the time, nearly all of the time, most of the time, about half the time, less than half the time).
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Therapeutic drug monitoring
大体时间：Maximum 1 year
Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry).
Maximum 1 year
EQ-5D-5L
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
EQ-5D-5L is an 5 item (plus a VAS scale) self-report-questionnaire assessing self-reported health. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Smoking status
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Smoking status (smoker, previous smoker, never smoker)
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises 14 items and determine the levels of anxiety and depression that a patient is experiencing, and generates 2 sub-scales; HADS-D and HADS-A. HADS-Anxiety and/or HADS-depression score ≥/< 8
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Heart Continuity of Care Questionnaire (HCCQ-16)
大体时间：Pre-intervention, Immediately after the intervention, 6-month follow-up.
Comprises 16 items covering eight topic areas: heart condition explained, communication among providers, preparation for discharge, post-hospital review of treatment, receipt of conflicting information, information on medications and on physical and dietary needs. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).
Pre-intervention, Immediately after the intervention, 6-month follow-up.
Health Literacy Questionnaire (HLQ)
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Comprises 20 items measuring four levels of health literacy: Appraisal of health information (5 items); social support for health (5 items); Ability to find good information (5 items); and Understanding health information (5 items). Each score provides insight into the strengths and limitations of the respondent, but the scores are most powerful when viewed together to show the 'health literacy profile' of the respondent.
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The eHealth Literacy Scale
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The eHealth Literacy Scale (Eheals) is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. Respondents indicate their agreement with statements on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly agree).
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Sleep Sufficient Index (SSI)
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Sleep Sufficiency Index (SSI) is calculated by dividing an individual's actual habitual sleep duration by their estimated needed sleep duration. It measures whether a person is getting enough sleep to feel rested, based on their personal requirements rather than a set number of hours. SSI >0.8: Classified as having sufficient sleep, provided the total duration is also > 6 hours. SSI < 0.8: Classified as having insufficient sleep, even if total sleep time is relatively high.
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Minimal Insomnia Symptom Scale (MISS)
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Minimal Insomnia Symptom Scale (MISS) is scored by summing the responses to three items covering difficulty falling asleep, staying asleep, and waking too early. Each item is rated on a 5-point scale (0-4), resulting in a total score from 0 to 12. A score of ≥6 is generally used as the cut-off to identify clinical insomnia in adults.
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Exercise
大体时间：VO2peak: start and end of the 12-week programme. Self-reported intensity adjusted minutes and Activity monitoring: during the 12-week programme,
VO2peak, Self-reported intensity adjusted minutes, activity monitoring
VO2peak: start and end of the 12-week programme. Self-reported intensity adjusted minutes and Activity monitoring: during the 12-week programme,
Bioimpedance
大体时间：Baseline and start and end of the 12-week programme
Visceral fat, muscle mass, body fat, BMI
Baseline and start and end of the 12-week programme
Charlson Comorbidity score
大体时间：Baseline
Charlson Comorbidity score ≥/< 5
Baseline
Frailty
大体时间：Baseline, Immediately after the intervention
The Clinical Frailty Scale (CFS) is scored on a 1-9 scale based on clinical judgment of a patient's baseline functional status. It assesses mobility, function, cognitive ability, and comorbidities, ranging from 1 (Very Fit) to 9 (Terminally Ill)
Baseline, Immediately after the intervention
Digital Health Readiness
大体时间：Baseline, start and end of the 12-week programme
The Digital Health Readiness Questionnaire (DHRQ) is scored by summing responses from four main domains (15-75 range) using a 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). A higher score indicates greater digital readiness.
Baseline, start and end of the 12-week programme
Fatigue
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
A visual analog scale ranging from 0 (fatigue is not a problem) to 10 (fatigue is a major problem) is used to measure change in fatigue
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Diet and nutrition
大体时间：Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The diet section of the Trøndelag Health Study (HUNT3) is scored based on self-reported questionnaires-specifically, a short food frequency questionnaire (FFQ) designed to measure adherence to Norwegian dietary recommendations. The scoring typically translates frequency of intake into a diet quality index or a total adherence score, often based on a 0-5 or higher scale, where higher scores represent a healthier diet
Baseline, Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
Frailty
大体时间：Baseline, Immediately after the intervention
The Study of Osteoporotic Fractures (SOF) index will be used to measure frailty status. The SOF index includes three items: 1) weight loss > 5% in the last year, 2) inability to rise from a chair five times without using arms, and 3) reduced energy level. The questions have dichotomous response alternatives (yes/no). Patients who meet none of these criteria will be considered robust, one of the criteria are pre-frail, and two or three of these criteria are considered frail.
Baseline, Immediately after the intervention
HeartQol
大体时间：Immediately after the intervention
14-item, heart-specific tool (for ischemic heart disease) scored on a 4-point Likert scale, ranging from 0 ("A lot") to 3 ("Not at all"). It measures physical (10 items) and emotional (4 items) quality of life, where higher mean scores (0 to 3) indicate better health-related quality of life
Immediately after the intervention
Beliefs About Medicines Questionnaire
大体时间：Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.
The Beliefs about Medicines Questionnaire (BMQ) assesses beliefs and perceptions about medicines and treatment. The BMQ comprises two sections: the BMQ-Specific which assesses representations of medication prescribed for personal use and the BMQ-General which assesses beliefs about medicines in general. The two sections of the BMQ can be used in combination or separately. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).
Pre-intervention, Immediately after the intervention, 6-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up.

其他结果措施

结果测量
措施说明
大体时间
Biomarkers
大体时间：Baseline and end of the 12-week programme
Blood: Cardiac and inflammation markers. Urine: amino acid metabolites, organic acids and intermediates of fatty acid oxidation.
Baseline and end of the 12-week programme
Blood pressure
大体时间：Baseline, start and end of the 12-week programme
Baseline, start and end of the 12-week programme
Total number of ED contacts
大体时间：Up to 10 years
Up to 10 years
Cognition
大体时间：Baseline
The 4AT is a 0-12 point delirium screening tool. Score 4 or more suggests delirium; 1-3 suggests cognitive impairment; 0 suggests no delirium/severe impairment
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Haukeland University Hospital

合作者

Yale University
University of Copenhagen
University of Bergen
The Research Council of Norway
Linkoeping University
University of Amsterdam
University of Sydney
University of Cambridge
Helse Fonna
Helse Vest
Western Norway University of Applied Sciences
Helse Møre og Romsdal HF
University of Regina
Østfold University College
Bergen Municipality
Voss Sykehus
The Norwegian Heart and Lung Patients Association (LHL)
Helse Førde HF
Helse Vest IKT
Youwell
Norsk råd for digital etikk
Center for Research on Cardiac Disease in Women
Nasjonal kompetansetjeneste Trening som medisin
RELIS Vest
Norwegian Centre for E-health Research
Sunnfjord Municipality
Sogndal Municipality
Masfjorden Municipality
E-helse Vestland

调查人员

  • 首席研究员：Tone M Norekvål, PhD、Haukeland University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月21日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2037年12月31日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • F-12624 (其他赠款/资助编号：Western Norway Regional Health Authority)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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