Smart and Healthy Ageing Through People Engaging in Supportive Systems (SHAPES) Digital App and Platform for Supporting Medicines Control and Optimization in Older Individuals With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clinika de Kay SL
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Technology Acceptance Model (TAM) questionnaire
Study Overview
Brief Summary
The intervention being piloted in this study is a novel system of supporting older individuals (>60 years old) with heart failure to self-manage their chronic condition through the use at home of a digital health tool that facilitates the collection and visualisation of their health data and also enables remote visualisation by health professionals. This pilot is a feasibility study in order to have a first evaluation of the engagement and user-perceived usefulness of the novel system in a real-world environment. An equivalent study will be carried out in Germany (GEWI institute). In addition, collected data will serve to validate retrospectively a heart failure decompensation prediction model (VICOMTECH, Spain) and do research into correlations with disease control (TREE TECHNOLOGY, Spain). Finally, this project is undertaken within the European project SHAPES (www.shapes2020.eu).
Older person participants (users of HUMANA GROUP services) will be asked to download the SHAPES app to their own smartphone. Medical devices - specifically, a body composition scale, a blood pressure monitor, a pulse oximeter - and a non-medical, CE-marked activity wristband, will also be provided to participants for use at home. Participants will be encouraged to take daily readings with medical devices and wear the wristband at all times. Participants can view their data via the app, which collects the readings either via Bluetooth or manually inserted by the participant. Participants will also be encouraged to complete surveys via a chatbot in the app, with questions about health status (daily), the use of medicines (weekly) and whether there are updates in medication, use of health care resources or lab test results (as required).
Health professional participants (medical doctors at HUMANA GROUP) will be able to visualise some of the collected data via: 1) eCare dashboard (data from medical devices; it is worth highlighting that they will only visualise the data coming from medical, that is not from the wristband, in order to avoid interference of non-medical information); and 2) ROSA dashboard (data from surveys and other medical data collected at baseline and during the intervention, i.e. medication, use of health care resources and lab test results). Health professional participants will use the dashboards on a daily basis and may decide to contact the older person participants for further medical evaluation.
Detailed Description
INTRODUCTION AND FINDINGS People who are aged 65 years and older account for almost a fifth of the population of the European Union. The number of people in this age group is projected to reach 151 million in 2060. Thus, there is an imperative to keep people healthy and active as they age. As age increases, however, so too does the prevalence of people living with long term conditions and subsequently, the number and complexity of treatment regimens to manage those conditions, also known as polypharmacy. In addition, the location of care delivery is also adapting - shifting routine care from hospitals to homes and the community. Home is a more comfortable and familiar setting for people and, as it has been the case during the COVID-19 pandemic, home is safer too. Individuals with chronic health conditions require regular and specialist care and support. The use of information and communication technologies (eHealth) offers opportunities to support and enhance home care.
Health literacy and individual involvement will be key elements in the successful introduction of eHealth into the health and social care system. The Smart & Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation Action (www.shapes2020.eu), a European project in which HUMANA GROUP is a member, intends to build, pilot and deploy a large-scale, EU-standardised open platform. SHAPES large-scale piloting campaign will engage +2k older individuals in 15 pilot sites in 10 EU Member States, including six European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) Reference Sites, and involve hundreds of key stakeholders. SHAPES multidisciplinary approach to large-scale piloting is reflected across seven themes that, together, provide a clear understanding of the reality of European health and care systems and enable the validation of cost-efficient, interoperable and reliable innovations capable of effectively supporting healthy and independent living of older individuals within and outside the home.
The Medicines Optimisation Innovation Centre (MOIC), which is hosted by the Northern Health and Social Care Trust (NHSCT) is an EIP on AHA reference site and is dedicated to driving innovation in medicines use. The MOIC is leading Pilot Theme 3 of the SHAPES pilot: 'Medicines control and optimisation', wherein the SHAPES platform and selected digital solutions will be used to help participants self-monitor their health condition(s), physiological parameters and medicines adherence. Within this pilot theme there are multiple 'use cases' each deploying and evaluating different digital solutions in several European countries according to the type of support required. Four use cases will be used to evaluate this pilot theme. The project in this document describes the piloting of the use case led by CLINIKA DE KAY and carried out in Mallorca, Spain.
The use case of this project study focuses on older persons with a heart failure condition in stages 2 (patients have minor limitations while performing physical activities) or 3 (minimal ordinary activity results in weakness). Main symptom which limits quality of life is shortness of breath when patient exerts themselves or even at rest. It reduces capacity of patient to perform daily activities. An optimal management of the disease by patients is essential to prevent decompensation, a sudden functional deterioration of the heart that may lead to hospitalisation.
The combination of multiple medicines along with, many times, a change in life-style makes the management of the disease difficult. In addition, factors associated with age increase the complexity for older individuals. Adherence to treatment and life-style is usually not optimal. Finally, many individuals of this group should go to medicine reconciliation, a process which is not widely extended in health services.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Users of HUMANA GROUP
- •Aged 60 years old or older at the time of recruitment
- •Diagnosed with heart failure at stage 2-3
- •Self-reported capacity (alone or with help) to use at least 2 devices among blood pressure meter, weight scale and pulse oximeter.
- •Living at home or in sheltered apartments.
- •Self-reported capacity to consent
- •Self-reported confident user of smartphone
- •Daily access to internet
- •Access to an android smartphone, with android version greater or equal to 6
Exclusion Criteria
- •Not meeting the inclusion criteria
Outcomes
Primary Outcomes
Technology Acceptance Model (TAM) questionnaire
Time Frame: End of the use of the novel system
The Technology Acceptance Model (TAM) is designed to measure the adoption of new technology based on customer attitudes.
Timestamps of login into the novel system
Time Frame: 3 months
How many times the person uses the digital solution being tested. It is expected to be used once a day.
Regarding the app, identification of pages seen, page login timestamp; page logout timestamp; measurement insertion timestamp; identification if measurement is manual or automatic
Time Frame: 3 months
The processed followed by the person within the app will be analised in order to study the user experience and the potential difficulties to use the app.
Short version of User Experience Questionnaire
Time Frame: End of the use of the novel system
The user experience questionnaire (UEQ) is a widely used questionnaire to measure the subjective impression of users towards the user experience of products.
Notes taken at an unstructured interview
Time Frame: End of the use of the novel system
Users will be able to express any comments or suggestions other than the ones collected with the questionnaires.
Secondary Outcomes
No secondary outcomes reported
