ECardiacRehab - a Pragmatic Trial on a Home-based Patient-centered E-Health Programme with Tailored Solutions - Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Haukeland University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The participants' engagement and adherence to the intervention
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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 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.
Investigators
Eligibility Criteria
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
- •Are living at home and have internet available to them
- •Providing 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Hospitalization(180 days hospitalization)
- Change in beliefs and perceptions about medicines and treatment(Up to 24 months.)
- Continuity of care(Self-report up to 6 months.)
- Change in health literacy(Up to 24 months)
- Anxiety and depression(Up to 24 months)
- Maximal oxygen consumption (Vo2 max)(Baseline and 12 weeks.)
- Healthcare utilization(Up to 24 months.)
- Healthcare cost(Up to 24 months.)
- Change in health status following myocardial infarction(Up to 24 months.)
- Change in fatigue(Up to 24 months)
- Change in eHealth literacy(Up to 24 months)
- Change in medication use(Up to 10 years)
- Change in physical and mental dimensions of health(Up to 24 months)
- Health related quality of life(Up to 24 months)
- Medication adherence assessed by therapeutic drug monitoring(Baseline, 3 and 6 months)
- Change in self-reported medication adherence(Up to 24 months)
- Change in chest pain(Up to 24 months)
- Change in self-reported health(Up to 24 months)
- Digital health readiness(Up to 24 months)
- Change in insomnia(Up to 24 months)
- Change in sleep(Up to 24 months)
- Blood samples(Baseline, 3 and 6 months.)
- Change in blood pressure(Up to end of programme)
- Change in biometrics(Baseline, start and end of programme)
- Change in nicotine status(Up to 24 months)
- Change in self-reported intensity-adjusted minutes(Up to 24 months)
- Biosensor data(Throughout the 12-week program)