None listed
Conditions
Brief summary
Patients with hypertension, coronary artery disease,obesity and diabetes are at higher risk of COVID-19 mortality or severe illness. Many high risk patients are not attending regular medical reviews due to these risks. It is likely the COVID-19 pandemic will accelerate the transition to digital healthcare systems but it is important to establish that these systems are safe and potentially improve care of high risk patients. Systems that allow ongoing care of patients in isolation without physical attendance may be very important for high risk patients with cardiac disease. This study will potentially validate this model of care, assess improvement in patient outcomes and define obstacles to implementation of digital based patient care models. It may then potentially serve as a model of care for other high risk patient conditions in COVID-19 isolation (e.g. diabetes).
Interventions
In this study, participants will be randomly allocated to use of a smartphone application (app) in addition to standard care, or standard care alone, to manage their pre-existing heart condition.
The smartphone app gives patients an effective method of capturing data such as blood pressure readings, medication adherence, task completion (e.g. exercise and rehabilitation programs) stress, blood pressure and heart rate, steps, goals, and other Patient Reported Outcomes Measures. The smartphone a
In this study, participants will be randomly allocated to use of a smartphone application (app) in addition to standard care, or standard care alone, to manage their pre-existing heart condition. The smartphone app gives patients an effective method of capturing data such as blood pressure readings, medication adherence, task completion (e.g. exercise and rehabilitation programs) stress, blood pressure and heart rate, steps, goals, and other Patient Reported Outcomes Measures. The smartphone app has been used to support cardiac rehabilitation previously, and has been scientifically validated to match or exceed outcomes of traditional cardiac rehabilitation. The smartphone app will require participants to enter data in the smartphone app, which will be reviewed via a secure cloud-based portal by the participant's clinician. This provides the opportunity for clinicians to monitor the participant's health status remotely and prescribe timely intervention via telephone consultation or a request to attend an in-person clinic visit if required. A task schedule for data entry will be customised by the research personnel for each participant based on the patient's clinical scenario and the Danish Heart Failure Registry. Data entry and task compliance will be reviewed weekly by the research staff via the online clinician portal. Participants will be trained in how to use the smartphone app by research nurses. This will be performed at study entry after participants provide informed consent and will take approximately 30 minutes. The maximum frequency of data entry (for participants with severe symptoms) will be daily and take approximately 5 minutes. The total duration of participation will be 12 months.
Sponsors
Wesley Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years and over at the time of consent 2. Left Ventricular (LV) Dysfunction or heart failure, defined as: a. Reduced LV function on echocardiography – either current or previous which has normalised on therapy b. Prior symptomatic heart failure events including preserved LV function 3. Technical skills to use smart device, as assessed by a standard screening tool 4. Appropriate smart device 5. Informed consent to participate
Exclusion criteria
1. Other terminal disease 2. Impaired cognitive function that precludes regular use of the app system 3. Planned transfer of care to a different geographical location
Outcome results
None listed