Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05353803 |
| Other study ID # |
UC-PT3-001-CH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Clinika de Kay SL |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The SHAPES platform along with selected digital solutions belonging to partners of the SHAPES
consortium (eCare from EDGENEERING and ROSA from HUMANA GROUP) can become eHealth tools for
disease self-management that are particularly designed for older persons. In addition to
self-management, they provide digital complements to share data with health professionals,
thus helping the integration of home disease self-management and health services. In the
presented project, the main objective is to evaluate whether users engage with such a system
and if it is useful for them (self-perceived usefulness).
HYPOTHESIS AND OBJECTIVES Hypothesis: This study will test the hypothesis that the SHAPES
platform and Digital Solutions (novel system) are capable of providing opportunities for
supporting the management of the heart failure condition, by both older persons/caregivers
and health professionals.
Objectives Primary objectives
- To investigate user engagement with the novel system.
- To investigate the user-perceived usefulness of the novel system. Secondary objectives
- To investigate the capability of the novel system to optimise the use of medicines in
homes:
- Novel system triggers contacts between health professionals and patients resulting
in medication change;
- Improving medical adherence to pharmaceutical treatments.
- To investigate the capability of the novel system to improve the management of medical
conditions.
- To investigate the identification of associations between precursor signs of
deterioration and healthcare resource use.
- To investigate the use of Statistical Process Control (SPC) techniques to find
associations between blood pressure, weight, heart rate and O2 saturation and healthcare
resource use.
- To investigate the association of the VICOM's heart failure decompensation prediction
score with healthcare resource use, particularly hospitalisations.
- To investigate the association of the first (active / sedentary behaviour) and second
level (active in activities of daily living / intermediate activity / exercise) of
physical activity classification and sleep quality analysis with healthcare resource
use.
- To investigate the capability of the novel system to improve older individual's quality
of life, wellbeing and psychological and psychosocial aspects.
- To explore the integration of the novel system to align with current care pathways
(SO9).
- To explore user trust and acceptance of the novel system. Tertiary objectives
The following objectives align with the general purposes of the SHAPES large-scale piloting
campaign:
- To validate the capability of the SHAPES Platform and Digital Solutions to support and
extend healthy and independent living for older individuals who are facing permanently
or temporarily reduced functionality and capabilities.
- To validate the capability of the SHAPES Platform and Digital Solutions to improve the
older individuals' health outcomes and quality of life.
- To validate the capability of the SHAPES Platform and Digital Solutions to gain the
older individuals' trust and acceptance.
- To validate the capability of the SHAPES Platform and Digital Solutions to gain the care
professionals' trust and acceptance.
- To validate the capability of the SHAPES Platform and Digital Solutions to contribute
for the reduction of the workload of medical professionals.
- To validate the capability of the SHAPES Platform and Digital Solutions to deliver
efficiency gains in health and care delivery across Europe.
METHODOLOGY Materials CE-marked Medical devices: OMRON VIVA Smart Scale; OMRON M7 Intelli IT
blood pressure meter; Beurer GmbH PO60 Bluetooth pulse oximeter.
CE-marked devices: Xiaomi Mi Band 3 activity wristband. Software from SHAPES partners: SHAPES
platform (SHAPES consortium); eCare (EDGENEERING); ROSA (HUMANA GROUP); SHAPES app and web
(combination of components from eCare, ROSA and Adilib chatbot engine from VICOMETECH); Heart
failure decompensation prediction algorithm (VICOMTECH); Sleep quality and Physical intensity
level and Vitals control (TREE TECHNOLOGY).
Other software: Excel, Libreoffice; Questionnaires: Those listed in outcomes.
Methods:
- Data integrity of non-CE software
- Recruitment of older persons and caregivers
- Screening: Members of the direct care team at HUMANA GROUP will screen their user lists
for potentially eligible participants.
- Invitation
- Information sheets
- Consent to contact
- Eligibility confirmation
- Test in a controlled environment: 3 older person participants and 1 health professional
will be invited to participate in a pre-study pilot for 1 week.
- Baseline procedures: Within 7 days before the start; For collected data.
- Intervention procedures:
All participants: On the first day, a face-to-face session with the researcher, participants
will register in the SHAPES platform, devices and links will be provided and a training
session will be given. The first week of the pilot will be considered a run-in period.
App users: during the pilot, the participant will be asked to record data via the SHAPES app
with medical devices. They will be encouraged to take at least one measurement per device a
day in the morning. Activity and sleep data is collected with CE-marked Xiaomi Mi Band 3,
which will be encouraged to wear at all times. With the SHAPES app, the user can transfer
data from the device to the app via Bluetooth or enter them manually. Participants will be
encouraged via chatbot to answer questionnaires on a weekly and daily basis, respectively. In
addition, participants will be encouraged to communicate through the chatbot in SHAPES app
whether they have contacted a health professional, have new laboratory test results, have
been hospitalised or their medication has changed. Independently to the scheduling of the
questionnaires, the participants can answer them at any time or decide not to do so. In any
case, the study will continue as the objective is to test the novel system in real world.
Health professionals: They will use the dashboards at least once on their working days to
visualise data from medical devices, questionnaires collected by the chatbot and other
collected medical data. If the health professional participant decides to contact the older
person participant for a medical evaluation, they will self-complete a form describing the
intervention. A medical doctor researcher will fill the grade of the intervention. Based on
their own criteria, they may schedule survey reminders and pieces of advice to be shown in
the chatbot.
- End of intervention (Within 14 days after the end of the intervention; For collected
data): These data will be collected in face-to-face, one-to-one interviews or through
forms to fill individually with the presence of a researcher for resolving doubts.
- Follow-up study procedures (3-month follow-up; For collected data): These data will be
collected in face-to-face, one-to-one interviews or through forms to fill individually
with the presence of a researcher for resolving doubts.
Data management CLINIKA DE KAY will be the data controller for all data collected during this
pilot. Data Processing Agreements will be put in place between CLINIKA DE KAY and each SHAPES
partner who processes data. During data collection and intervention, data processing will be
pseudonymised. In analysis period, data processed by partners will be de-identified.
WORK PLAN
Research team:
- Dra. Karina Anahi Ojanguren Carreira: Medical director at HUMANA GROUP, principal
investigator of the study and medical doctor researcher (PI; MD-researcher).
- Esperança Lladó Pascual, project manager and researcher at HUMANA GROUP (PM)
- Ezequiel Corredera Blanco and José María Polo, technical team at HUMANA GROUP (TT-CH)
- Researchers at VIOMTECH, TREE TECHNOLOGY.
- GEWI institute (replicating site; an equivalent study will be carried out by GEWI
institute)
- National University Ireland Maynooth: Coordinator SHAPES project (Coord-SHAPES)
- Northern Health and Social Health Trust, Coordinators of Pilot Theme 3 in SHAPES
(PT3-SHAPES)
