Remote monitoring of patients with aortic stenosis Circulatory System
Conditions
Interventions
Remote patient monitoring:
The AS App & Clinician’s Portal has been developed via a process of participatory design in collaboration with our patients and clinicians and will collect both subjective
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with asymptomatic sAS of a native valve 2. Aortic valve area 40mmHg and left ventricular ejection fraction (LVEF) >50% (in the last 6 months) 3. Able to give written informed consent 4. Aged =18 years old 5. Able to access and use app-based programmes (using the English language)
Exclusion criteria
Exclusion criteria: 1. Lack of capacity to understand the nature of the study and possible consequences as assessed by their attending clinician 2. Significant disease of other valves e.g. mitral stenosis/regurgitation 3. Co-morbidities that in the opinion of the cardiac surgeon/cardiologist preclude successful valve intervention e.g. life expectancy of fewer than 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary measures are measured using data from the app at the conclusion of the follow-up period: 1. Assess the utility of the “app” measured using quantitative app usage data and data completeness recorded in the app and qualitative interview data 2. Assess engagement with the intervention 3. Recruitment rate per month 4. Number of withdrawals and losses to follow up (with reasons) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes measured using medical records and the data populated within the case report form (CRF), unless otherwise stated: 1. Time to heart valve replacement over 12 months follow up 2. In-hospital mortality over 12 months follow up 3. Mortality at 30 days post-randomisation 4. Mortality at 12 months post-randomisation 5. Incidence of stroke over 12 months follow up 6. Incidence of myocardial infarction over 12 months follow up 7. Left ventricular ejection fraction (LVEF) at 6 and 12 months 8. Incidence of unplanned hospital admissions over 12 months follow up 9. Number of health-related contacts due to symptom development and/or deterioration during study enrolment over 12 months follow up 10. Quality of life measured using the patient-reported outcome measure Kansas City Cardiomyopathy Questionnaire (KCCQ) score captured from the app and collected at baseline, monthly via the app until 12 months in those assigned to the intervention arm. For those assigned to standard care, these data will be collected at baseline, 6 months and 12 months. 11. Frailty/functional capacity measured using the Timed Up and Go (TUG) test score self-reported by patients in the interventional arm every two weeks and at 6 and 12 months for patients assigned to standard care, over 12 months follow up Secondary outcomes post heart valve replacement only measured using medical records and the data populated within the case report form (CRF): 1. Incidence of major bleeding (as defined in Valve Academic Research Consortium clinical outcomes) over 12 months follow up 2. Incidence of vascular access site or access-related complications over 12 months follow up 3. Incidence of acute kidney injury over 12 months follow up 4. Incidence of conduction disturbances over 12 months follow up 5. Incidence of arrhythmias over 12 months follow up | — |
Countries
England, United Kingdom
Outcome results
None listed