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

18 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Inny: eCardiacRehab

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1000

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Trond R Pettersen, PhD
Numer telefonu: +4748124938
E-mail: trond.roed.pettersen@helse-bergen.no

Lokalizacje studiów

Norwegia
- - Bergen, Norwegia
    - Rekrutacyjny
    - Haukeland University Hospital
    - Kontakt:
      
      Trond R Pettersen, PhD
      
      Numer telefonu: +4748124938
      
      E-mail: trond.roed.pettersen@helse-bergen.no

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Brak interwencji: Zwykła opieka Brak interwencji
Aktywny komparator: eCardiacRehab Digital cardiac rehabilitation	Inny: eCardiacRehab 12-week digital cardiac rehabilitation

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Composite clinical hierarchy of outcomes Ramy czasowe: 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.

Miary wyników drugorzędnych

Inne miary wyników

Miara wyniku	Opis środka	Ramy czasowe
Biomarkers Ramy czasowe: 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 Ramy czasowe: Baseline, start and end of the 12-week programme		Baseline, start and end of the 12-week programme
Total number of ED contacts Ramy czasowe: Up to 10 years		Up to 10 years
Cognition Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Haukeland University Hospital

Współpracownicy

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

Śledczy

Główny śledczy: Tone M Norekvål, PhD, Haukeland University Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Study website

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

21 maja 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2037

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

15 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

F-12624 (Inny numer grantu/finansowania: Western Norway Regional Health Authority)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Miara wyniku	Opis środka	Ramy czasowe
Cardiovascular mortality Ramy czasowe: 1, 3, 5 years	Time to cardiovascular cause death from randomization.	1, 3, 5 years
Cardiovascular Emergency Department contact Ramy czasowe: 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 Ramy czasowe: 1, 3, 5 years	Time to all-cause death from randomization	1, 3, 5 years
All-cause Emergency Department contact Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: Maximum 1 year	Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry).	Maximum 1 year
EQ-5D-5L Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: Baseline	Charlson Comorbidity score ≥/< 5	Baseline
Frailty Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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.

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

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

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Szacowany)

Faza

Kontakty i lokalizacje

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Inne miary wyników

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Współpracownicy

Śledczy

Publikacje i pomocne linki

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Szacowany)

Ukończenie studiów (Szacowany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA