Coronary Artery DiseaseeCardiacRehabNCT06759805
Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study
A study testing eCardiacRehab in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiac Rehabilitation, Ethics
- What is being tested?
- eCardiacRehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 6 Jan 2025to 30 Oct 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number,
- With coronary artery disease after percutaneous coronary intervention
- Are living at home and have internet available to them
- Providing signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: eCardiacRehab - a Pragmatic Trial on a Home-based Patient-centered e-Health Programme With Tailored Solutions - Feasibility Study
In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations 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 eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.
- Conditions
- Coronary Artery Disease, Cardiac Rehabilitation, Ethics, Continuity of Patient Care, Older Adults (65 Years and Older), Cost-Benefit Analysis
- Being tested
- eCardiacRehab
- Medical subject headings
- Coronary Artery Disease, Medication Adherence, Treatment Adherence and Compliance, Psychological Well-Being, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCardiacRehabOther
Interdisciplinary supervised home-based digital secondary prevention programme (12-week programme) based on the European Society of Cardiology guidelines for cardiac rehabilitation for patients after percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care |
| Intervention group | Other | Digital cardiac rehabilitation Receives: Other: eCardiacRehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The participants' engagement and adherence to the intervention
Based on previous studies, the success criteria will be one login to the website on average once per week, and that 50% of participants will watch some or all the video messages on the website. Usage will be assessed as time spent using the programme, number of logins with start and end time, summary of number of sessions, messages sent, modules completed, and registrations per patient, number of completed questionnaires per patient, and start and end time for all modules in the programme. This will be assessed based on website usage statistics gathered by a website visit tracking system. Further, participants will be asked to report login-errors.
Measured: From start to the end of the programme (12 weeks)
Missing rate
Acceptability of the secondary and primary outcomes is assessed through response and completion rates. The proportion of missing data in each completed questionnaire at baseline and at the end of the intervention of less than 20% is acceptable.
Measured: From start to end of programme (12 weeks)
Attrition rate
A success criterion to reduce the threats to validity is an attrition rate of no more than 20%. When possible, the reasons for participants leaving the study are obtained and reported in a study log.
Measured: From start to the end of programme (12 weeks)
Secondary outcomes (27)
Hospitalization
Composite end-point of Emergency Department (ED) contact and home, ED and observation, ED and admission (>24 hours), and death, whichever comes first.
Measured: 180 days hospitalization
Change in beliefs and perceptions about medicines and treatment
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. For this study, the BMQ-Specific will be used. Respondents rate 11 items on a 5-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).
Measured: Up to 24 months.
Continuity of care
The Heart Continuity of Care Questionnaire (HCCQ) comprises 33 items covering eight topic areas regarding continuity of care. Respondents rate each item on a 6-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) or 6 (not applicable).
Measured: Self-report up to 6 months.
Change in health literacy
The Health literacy questionnaire (HLQ) has nine scale scores that each measure an aspect of the multidimensional construct of health literacy. 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
Measured: Up to 24 months
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).
Measured: Up to 24 months
Maximal oxygen consumption (Vo2 max)
Maximal oxygen consumption (VO2max) as measured by cardiopulmonary exercise testing (CPET).
Measured: Baseline and 12 weeks.
Healthcare utilization
Healthcare utilization will be assessed during follow-up, including patients' use of primary care services (general practitioner visits) and secondary care services (inpatient admissions and outpatient visits). The data source will be nationwide registries. The measurement unit will be mean number of visits.
Measured: Up to 24 months.
Healthcare cost
Health care (associated) costs will be valued using the tariffs of national agreements between the professional associations of medical specialists and the National Health Services. In secondary care, inpatient admissions and outpatient visits will be valued using the tariffs of the national case-mix system of the diagnosis-related groupings (DRG) and the ambulatory grouping system (DAGS). In addition, data will be collected on prescription of medication, which will be valued using the retail price. The data source will be nationwide registries. The measurement unit will be mean costs in Euros.
Measured: Up to 24 months.
Change in health status following myocardial infarction
The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where 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.
Measured: Up to 24 months.
Change in fatigue
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.
Measured: Up to 24 months
Change in eHealth literacy
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).
Measured: Up to 24 months
Change in medication use
Data related to consumption of prescribed medication are identified through national prescription registries. The registries cover all prescriptions dispensed at pharmacies nationwide. The registries also include information about date of dispensation, quantity and strength dispensed. This will serve as complimentary information to patients' self-reported adherence.
Measured: Up to 10 years
Change in self-reported medication adherence
The my experience of taking medicines (MYMEDS) questionnaire consists of six sections. Section 1: essential contextual information (e.g. the medicines taken). Section 2: overall understanding and satisfaction with medicines (four-point Likert scale (strongly agree, agree, disagree, strongly disagree)). Section 3: areas of anxiety about medicines (e.g. worry that they will cause more harm than good). Section 4: four separate practical concerns associated with medicines taking (e.g. swallowing problems). Section 5: assesses three issues in fitting medicines into patients' daily routine (e.g. relating to forgetfulness or inconvenience). Section 6: asks about adherence to each individual medicine over the past month (five point Likert scale). .
Measured: Up to 24 months
Change in physical and mental dimensions of health
RAND-12 measures physical and mental dimensions of health. The 12 items in the questionnaire correspond to eight principal physical and mental health domains. The 12 items are summarized into two scores, a "Physical Health Summary Measure (PCS-physical component score)" and a "Mental Health Summary Measure (MCS-mental component score)".
Measured: Up to 24 months
Health related quality of life
The HeartQoL questionnaire is a core ischemic heart disease specific health related quality of life (HRQL) questionnaire. The questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if needed.
Measured: Up to 24 months
Change in chest pain
The Seattle Angina Questionnaire (SAQ-7) comprises 7 dimensions of coronary artery disease. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Measured: Up to 24 months
Change in self-reported health
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.
Measured: Up to 24 months
Digital health readiness
Responses to the Digital Health Readiness Questionnaire (DHRQ) are scored on a 5-point Likert scale (strongly disagree to strongly agree). The sum of the first 4 domains gives the total score on the DHRQ. The minimum score of the DHRQ is 15, and the maximum score of the DHRQ is 75. Additionally, a fifth domain called digital learnability is assessed.
Measured: Up to 24 months
Change in insomnia
The Minimal Insomnia Symptom Scale (MISS) comprises 3 items assessing major features of insomnia, i.e. difficulties initiating sleep, waking at night and not feeling refreshed by sleep.
Measured: Up to 24 months
Change in sleep
The Sleep Sufficient Index (SSI) comprises 2 items assessing amount of actual and desired sleep.
Measured: Up to 24 months
Medication adherence assessed by therapeutic drug monitoring
Serum levels of cardiac medications (quantified using liquid chromatography with mass spectrometry)
Measured: Baseline, 3 and 6 months
Blood samples
HbA1c (≤7.0%), lipids, cardiac and inflammation markers(e.g. troponins, natriuretic peptides and CRP).
Measured: Baseline, 3 and 6 months.
Change in blood pressure
Blood pressure targets (<120/70 mmHg at nurse visit; <120/70 mmHg at home measurement)
Measured: Up to end of programme
Change in biometrics
BMI (WHO- classification), visceral fat, muscle mass, body fat.
Measured: Baseline, start and end of programme
Change in nicotine status
Self-reported change in nicotine status
Measured: Up to 24 months
Change in self-reported intensity-adjusted minutes
The the physical activity frequency, intensity, and duration (PAFID) questionnaire contains three items on physical activity: (i) frequency [never (0), less than once per week (0.5), once per week (1), 2-3 times per week (2.5), or almost every day (5)]; (ii) duration of each exercise session [<15 min (7.5), 15-29 min (22.5), 30-60 min (45), or over 60 min (75)]; and (iii) intensity [low ('I take it easy, I don't get out of breath or break a sweat'), moderate ('I push myself until I'm out of breath or break into a sweat'), or high ('I practically exhaust myself')]. The number of minutes of physical activity is calculated as the average time spent per session multiplied by the average frequency of exercise per week multiplied by the weighted intensity [low (0.5), moderate (1), and high (2)] based on the values in brackets.
Measured: Up to 24 months
Biosensor data
Biosensor data is collected throughout the 12-week program, and include time spent sedentary and in light-, moderate- and vigorous-intensity physical activity, daily step count, resting/maximal heart rate, sleep time and quality and time and duration of wearing the wearable device.
Measured: Throughout the 12-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start6 Jan 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Helse Vest IKT, Western Norway University of Applied Sciences, Youwell, University of Bergen, Østfold University College, Norsk råd for digital etikk, Helse Førde HF, University of Amsterdam, Center for Research on Cardiac Disease in Women, Nasjonal kompetansetjeneste Trening som medisin, RELIS Vest, Norwegian Centre for E-health Research, Bergen Municipality, Sunnfjord Municipality, Sogndal Municipality, Masfjorden Municipality, The Norwegian Heart and Lung Patient Organization, E-helse Vestland, Yale University, University of Sydney, University of Cambridge, University of Regina, University of Copenhagen, Linkoeping University, Voss Hospital, Norway
- Responsible party
- Sponsor
- Investigators
- Tone M Norekvål, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759805
- Sponsor's protocol ID
- 459136
- Other IDs
- 344337, F-12624, R-10930
- Acronym
- eCardiacRehab
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not made available for others according to the Norwegian data protection legislation.
Publications
Brors G, Pettersen TR, Hansen TB, Fridlund B, Holvold LB, Lund H, Norekval TM. Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review. BMC Health Serv Res. 2019 Jun 10;19(1):364. doi: 10.1186/s12913-019-4106-1.
PubMed 31182100Valaker I, Fridlund B, Wentzel-Larsen T, Nordrehaug JE, Rotevatn S, Raholm MB, Norekval TM. Continuity of care and its associations with self-reported health, clinical characteristics and follow-up services after percutaneous coronary intervention. BMC Health Serv Res. 2020 Jan 31;20(1):71. doi: 10.1186/s12913-020-4908-1.
PubMed 32005235Norekval TM, Allore HG, Bendz B, Bjorvatn C, Borregaard B, Brors G, Deaton C, Falun N, Hadjistavropoulos H, Hansen TB, Igland S, Larsen AI, Palm P, Pettersen TR, Rasmussen TB, Schjott J, Sogaard R, Valaker I, Zwisler AD, Rotevatn S; CONCARD Investigators. Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI). BMJ Open. 2020 Feb 12;10(2):e031995. doi: 10.1136/bmjopen-2019-031995.
PubMed 32054625Norekval TM, Allore HG. Cardiac rehabilitation in older adults: is it just lifestyle? Heart. 2020 Jul;106(14):1035-1037. doi: 10.1136/heartjnl-2019-316497. Epub 2020 Apr 16. No abstract available.
PubMed 32299827Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Osborne RH, Palm P, Wentzel-Larsen T, Norekval TM; CONCARD investigators. Health Literacy and Risk Factors for Coronary Artery Disease (From the CONCARDPCI Study). Am J Cardiol. 2022 Sep 15;179:22-30. doi: 10.1016/j.amjcard.2022.06.016. Epub 2022 Jul 16.
PubMed 35853782Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Norman CD, Palm P, Wentzel-Larsen T, Norekval TM. The association of electronic health literacy with behavioural and psychological coronary artery disease risk factors in patients after percutaneous coronary intervention: a 12-month follow-up study. Eur Heart J Digit Health. 2023 Feb 7;4(2):125-135. doi: 10.1093/ehjdh/ztad010. eCollection 2023 Mar.
PubMed 36974270Instenes I, Fridlund B, Borregaard B, Larsen AI, Allore H, Bendz B, Deaton C, Rotevatn S, Falun N, Norekval TM. 'When age is not a barrier': an explorative study of nonagenarian patients' experiences of undergoing percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2024 Sep 5;23(6):608-617. doi: 10.1093/eurjcn/zvad132.
PubMed 38243638Hjertvikrem N, Brors G, Instenes I, Helmark C, Pettersen TR, Rotevatn S, Zwisler ADO, Norekval TM; CONCARDPCI Investigators. Use of health services and perceived need for information and follow-up after percutaneous coronary intervention. BMC Res Notes. 2024 Jan 5;17(1):20. doi: 10.1186/s13104-023-06662-y.
PubMed 38183067Ferrel-Yui D, Candelaria D, Pettersen TR, Gallagher R, Shi W. Uptake and implementation of cardiac telerehabilitation: A systematic review of provider and system barriers and enablers. Int J Med Inform. 2024 Apr;184:105346. doi: 10.1016/j.ijmedinf.2024.105346. Epub 2024 Jan 24.
PubMed 38281451Norekval TM, Bale M, Bedane HK, Hole T, Ingul CB, Munkhaugen J. Cardiac rehabilitation participation within 6 months of discharge in 37 136 myocardial infarction survivors: a nationwide registry study. Eur J Prev Cardiol. 2024 Nov 18;31(16):1977-1980. doi: 10.1093/eurjpc/zwad350. No abstract available.
PubMed 37943676Pettersen TR, Schjott J, Allore H, Bendz B, Borregaard B, Fridlund B, Hadjistavropoulos HD, Larsen AI, Nordrehaug JE, Rasmussen TB, Rotevatn S, Valaker I, Wentzel-Larsen T, Norekval TM; CONCARD Investigators. Discharge Information About Adverse Drug Reactions Indicates Lower Self-Reported Adverse Drug Reactions and Fewer Concerns in Patients After Percutaneous Coronary Intervention. Heart Lung Circ. 2024 Mar;33(3):350-361. doi: 10.1016/j.hlc.2023.12.005. Epub 2024 Jan 18.
PubMed 38238118
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eCardiacRehab - a Pragmatic Trial on a Home-based Patient-centered e-Health Programme With Tailored Solutions - Feasibility Study
- ClinicalTrials.gov ID
- NCT06759805
- Acronym / sponsor ID
- eCardiacRehab / 459136
- Conditions
- Coronary Artery Disease, Cardiac Rehabilitation, Ethics, Continuity of Patient Care, Older Adults (65 Years and Older), Cost-Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Helse Vest, Helse Fonna, Helse Møre og Romsdal HF, Helse Vest IKT, Western Norway University of Applied Sciences, Youwell, University of Bergen, Østfold University College, Norsk råd for digital etikk, Helse Førde HF, University of Amsterdam, Center for Research on Cardiac Disease in Women, Nasjonal kompetansetjeneste Trening som medisin, RELIS Vest, Norwegian Centre for E-health Research, Bergen Municipality, Sunnfjord Municipality, Sogndal Municipality, Masfjorden Municipality, The Norwegian Heart and Lung Patient Organization, E-helse Vestland, Yale University, University of Sydney, University of Cambridge, University of Regina, University of Copenhagen, Linkoeping University, Voss Hospital, Norway
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2035 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations 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 eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care |
| Intervention group | Other | Other: eCardiacRehabDigital cardiac rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number,
- With coronary artery disease after percutaneous coronary intervention
- Are living at home and have internet available to them
- Providing signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCardiacRehabInterdisciplinary supervised home-based digital secondary prevention programme (12-week programme) based on the European Society of Cardiology guidelines for cardiac rehabilitation for patients after percutaneous coronary intervention. | Other | Intervention group |
Primary outcome
The participants' engagement and adherence to the intervention
Time frame: From start to the end of the programme (12 weeks)
Based on previous studies, the success criteria will be one login to the website on average once per week, and that 50% of participants will watch some or all the video messages on the website. Usage will be assessed as time spent using the programme, number of logins with start and end time, summary of number of sessions, messages sent, modules completed, and registrations per patient, number of completed questionnaires per patient, and start and end time for all modules in the programme. This will be assessed based on website usage statistics gathered by a website visit tracking system. Further, participants will be asked to report login-errors.
Missing rate
Time frame: From start to end of programme (12 weeks)
Acceptability of the secondary and primary outcomes is assessed through response and completion rates. The proportion of missing data in each completed questionnaire at baseline and at the end of the intervention of less than 20% is acceptable.
Attrition rate
Time frame: From start to the end of programme (12 weeks)
A success criterion to reduce the threats to validity is an attrition rate of no more than 20%. When possible, the reasons for participants leaving the study are obtained and reported in a study log.
27 secondary outcomes
Hospitalization
Time frame: 180 days hospitalization
Change in beliefs and perceptions about medicines and treatment
Time frame: Up to 24 months.
Continuity of care
Time frame: Self-report up to 6 months.
Change in health literacy
Time frame: Up to 24 months
Anxiety and depression
Time frame: Up to 24 months
Maximal oxygen consumption (Vo2 max)
Time frame: Baseline and 12 weeks.
Healthcare utilization
Time frame: Up to 24 months.
Healthcare cost
Time frame: Up to 24 months.
Change in health status following myocardial infarction
Time frame: Up to 24 months.
Change in fatigue
Time frame: Up to 24 months
Change in eHealth literacy
Time frame: Up to 24 months
Change in medication use
Time frame: Up to 10 years
Change in self-reported medication adherence
Time frame: Up to 24 months
Change in physical and mental dimensions of health
Time frame: Up to 24 months
Health related quality of life
Time frame: Up to 24 months
Change in chest pain
Time frame: Up to 24 months
Change in self-reported health
Time frame: Up to 24 months
Digital health readiness
Time frame: Up to 24 months
Change in insomnia
Time frame: Up to 24 months
Change in sleep
Time frame: Up to 24 months
Medication adherence assessed by therapeutic drug monitoring
Time frame: Baseline, 3 and 6 months
Blood samples
Time frame: Baseline, 3 and 6 months.
Change in blood pressure
Time frame: Up to end of programme
Change in biometrics
Time frame: Baseline, start and end of programme
Change in nicotine status
Time frame: Up to 24 months
Change in self-reported intensity-adjusted minutes
Time frame: Up to 24 months
Biosensor data
Time frame: Throughout the 12-week program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 31182100Brors G, Pettersen TR, Hansen TB, Fridlund B, Holvold LB, Lund H, Norekval TM. Modes of e-Health delivery in secondary prevention programmes for patients with coronary artery disease: a systematic review. BMC Health Serv Res. 2019 Jun 10;19(1):364. doi: 10.1186/s12913-019-4106-1.
- Background: PubMed 32005235Valaker I, Fridlund B, Wentzel-Larsen T, Nordrehaug JE, Rotevatn S, Raholm MB, Norekval TM. Continuity of care and its associations with self-reported health, clinical characteristics and follow-up services after percutaneous coronary intervention. BMC Health Serv Res. 2020 Jan 31;20(1):71. doi: 10.1186/s12913-020-4908-1.
- Background: PubMed 32054625Norekval TM, Allore HG, Bendz B, Bjorvatn C, Borregaard B, Brors G, Deaton C, Falun N, Hadjistavropoulos H, Hansen TB, Igland S, Larsen AI, Palm P, Pettersen TR, Rasmussen TB, Schjott J, Sogaard R, Valaker I, Zwisler AD, Rotevatn S; CONCARD Investigators. Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI). BMJ Open. 2020 Feb 12;10(2):e031995. doi: 10.1136/bmjopen-2019-031995.
- Background: PubMed 32299827Norekval TM, Allore HG. Cardiac rehabilitation in older adults: is it just lifestyle? Heart. 2020 Jul;106(14):1035-1037. doi: 10.1136/heartjnl-2019-316497. Epub 2020 Apr 16. No abstract available.
- Background: PubMed 35853782Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Osborne RH, Palm P, Wentzel-Larsen T, Norekval TM; CONCARD investigators. Health Literacy and Risk Factors for Coronary Artery Disease (From the CONCARDPCI Study). Am J Cardiol. 2022 Sep 15;179:22-30. doi: 10.1016/j.amjcard.2022.06.016. Epub 2022 Jul 16.
- Background: PubMed 36974270Brors G, Dalen H, Allore H, Deaton C, Fridlund B, Norman CD, Palm P, Wentzel-Larsen T, Norekval TM. The association of electronic health literacy with behavioural and psychological coronary artery disease risk factors in patients after percutaneous coronary intervention: a 12-month follow-up study. Eur Heart J Digit Health. 2023 Feb 7;4(2):125-135. doi: 10.1093/ehjdh/ztad010. eCollection 2023 Mar.
- Background: PubMed 38243638Instenes I, Fridlund B, Borregaard B, Larsen AI, Allore H, Bendz B, Deaton C, Rotevatn S, Falun N, Norekval TM. 'When age is not a barrier': an explorative study of nonagenarian patients' experiences of undergoing percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2024 Sep 5;23(6):608-617. doi: 10.1093/eurjcn/zvad132.
- Background: PubMed 38183067Hjertvikrem N, Brors G, Instenes I, Helmark C, Pettersen TR, Rotevatn S, Zwisler ADO, Norekval TM; CONCARDPCI Investigators. Use of health services and perceived need for information and follow-up after percutaneous coronary intervention. BMC Res Notes. 2024 Jan 5;17(1):20. doi: 10.1186/s13104-023-06662-y.
- Background: PubMed 38281451Ferrel-Yui D, Candelaria D, Pettersen TR, Gallagher R, Shi W. Uptake and implementation of cardiac telerehabilitation: A systematic review of provider and system barriers and enablers. Int J Med Inform. 2024 Apr;184:105346. doi: 10.1016/j.ijmedinf.2024.105346. Epub 2024 Jan 24.
- Background: PubMed 37943676Norekval TM, Bale M, Bedane HK, Hole T, Ingul CB, Munkhaugen J. Cardiac rehabilitation participation within 6 months of discharge in 37 136 myocardial infarction survivors: a nationwide registry study. Eur J Prev Cardiol. 2024 Nov 18;31(16):1977-1980. doi: 10.1093/eurjpc/zwad350. No abstract available.
- Background: PubMed 38238118Pettersen TR, Schjott J, Allore H, Bendz B, Borregaard B, Fridlund B, Hadjistavropoulos HD, Larsen AI, Nordrehaug JE, Rasmussen TB, Rotevatn S, Valaker I, Wentzel-Larsen T, Norekval TM; CONCARD Investigators. Discharge Information About Adverse Drug Reactions Indicates Lower Self-Reported Adverse Drug Reactions and Fewer Concerns in Patients After Percutaneous Coronary Intervention. Heart Lung Circ. 2024 Mar;33(3):350-361. doi: 10.1016/j.hlc.2023.12.005. Epub 2024 Jan 18.
- eCardiacRehab study pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not made available for others according to the Norwegian data protection legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone M Norekvål, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCardiacRehab in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The participants' engagement and adherence to the intervention (time frame: From start to the end of the programme (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759805, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.