A Non-randomised Pilot Study of the Smart and Healthy Ageing Through People Engaging in Supportive Systems (SHAPES) Digital App and Platform for Supporting Medicines Optimisation in Older Individuals With Multiple Long-term Conditions
Phase: NA
Conditions: Heart Failure, Diabetes, Diabetes Mellitus
Sponsor: Prof Michael Scott

Page 1 of 31 
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
 
 
A non-randomised pilot study of the 
Smart and Healthy Ageing through People 
Engaging in Supportive Systems (SHAPES) 
digital app and platform for supporting 
medicines optimisation in older 
individuals with multiple long-term 
conditions 
 
Protocol date: 
10/11/2022 
NCT number: 
NCT05249062 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Table of Contents 
 ................................................................................................................................................................ 1 
1. Administrative Information................................................................................................................. 4 
1.1 Project details ............................................................................................................................... 4 
1.2 Funding ......................................................................................................................................... 6 
1.3 Roles and responsibilities .............................................................................................................. 6 
2. Introduction ...................................................................................................................................... 10 
2.1 Background and rationale ........................................................................................................... 10 
2.2 Hypothesis ................................................................................................................................... 12 
2.3 Objectives.................................................................................................................................... 12 
2.4 Pilot design .................................................................................................................................. 13 
3. Methods ............................................................................................................................................ 13 
3.1 Study setting ............................................................................................................................... 13 
3.2 Eligibility criteria.......................................................................................................................... 13 
3.3 Intervention ................................................................................................................................ 14 
3.4 Outcomes .................................................................................................................................... 15 
3.5 Participant timeline ..................................................................................................................... 21 
3.6 Sample size .................................................................................................................................. 21 
3.7 Recruitment ................................................................................................................................ 21 
3.8 Data collection, management and analysis ................................................................................ 24 
3.8.1 Service user data collection methods .................................................................................. 24 
3.8.2 Healthcare professional data collection .............................................................................. 25 
3.8.3 Data collection tools ............................................................................................................ 26 
3.8.4 Adverse incidents ................................................................................................................. 26 
3.8.5 Risks to research staff .......................................................................................................... 27 
3.8.6 Protocol deviations .............................................................................................................. 27 
3.8.7 Data management ............................................................................................................... 27 
3.8.8 Missing data ......................................................................................................................... 28 
3.8.9 Data duplication ................................................................................................................... 28 
3.8.10 Data analysis ...................................................................................................................... 29 
3.8.11 Statistical methods ............................................................................................................. 29 
4 Ethics and dissemination ................................................................................................................... 29 
4.1 Research ethics approval ............................................................................................................ 29 
4.2 Protocol amendments ................................................................................................................ 29 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
4.3 Consent ....................................................................................................................................... 30 
4.4 End of pilot and termination criteria .......................................................................................... 30 
4.5 Confidentiality ............................................................................................................................. 30 
4.6 Declaration of interests............................................................................................................... 30 
4.7 Access to data ............................................................................................................................. 30 
4.8 Ancillary and post-trial care ........................................................................................................ 31 
4.9 Dissemination policy ................................................................................................................... 31 
5. References ........................................................................................................................................ 31 
 
 
 
 
 
 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
1. Administrative Information 
1.1 Project details 
 
 
 
 
 
 
 
 
 
 
 
 
 
Project Title: 
A non-randomised pilot study of the Smart and Healthy 
Ageing through People Engaging in Supportive Systems 
(SHAPES) digital app and platform for supporting 
medicines optimisation in older individuals with multiple 
long-term conditions 
Short title: 
SHAPES pilot: supporting multimorbid older people 
Acronym: 
SHAPES 
Grant Number: 
857159 
Protocol Number: 
NT21-SHAPES 
Protocol Version: 
Final v3.0 
Protocol date: 
10/11/2022 
Protocol 
amendment 
number: 
Non-SubAm01 
Registry: 
Clinicaltrials.gov 
Sponsor: 
Northern Health and Social Care Trust (NHSCT) 
Ethics reference 
number: 
284743 
UK Chief 
Investigator: 
Prof Michael Scott 
MOIC 
Pine House 
Antrim Hospital Site 
BT41 2RL 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Logos: 
 
 
 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
1.2 Funding 
This pilot study is part of the overall SHAPES Innovation Action, which has received funding from the 
European Union’s Horizon 2020 research and innovation programme under grant agreements No. 
857159. The funder has commissioned reports on the results of this pilot study (D6.4). 
1.3 Roles and responsibilities 
Sponsorship 
The pilot is sponsored by the Northern Health and Social Care Trust. 
Sponsor 
Frances Johnston 
Research Office 
Governance Department 
Bush House 
Bush Road 
Antrim 
BT41 2QB 
028 9442 4653 
frances.johnston@northerntrust.hscni.net 
Sponsor’s Reference 
NT21-SHAPES 
 
Study Team 
Chief Investigator 
Prof Michael Scott (NHSCT) 
drmichael.scott@northerntrust.hscni.net 
Co-Investigators 
Dr Glenda Fleming (NHSCT) 
Glenda.fleming@northerntrust.hscni.net  
NORTHERN HEALTH AND SOCIAL 
CARE TRUST (NHSCT) established in 
BRETTEN HALL ANTRIM AREA 
HOSPITAL SITE TRUST 
HEADQUARTERS, ANTRIM BT43 6DA, 
United Kingdom 
Dr Nicola Goodfellow (NHSCT) 
Nicola.goodfellow@northerntrust.hscni.net  
Dr Claire Scullin (NHSCT) 
Claire.scullin@northerntrust.hscni.net 
Maureen Spargo (NHSCT) 
Maureen.spargo@northerntrust.hscni.net 
Suzanne Martin (NHSCT) 
Suzanne.Martin@northerntrust.hscni.net 
Katherine O’Neill (NHSCT) 
Katherine.ONeill@northerntrust.hscni.net 
Rachel Huey (NHSCT) 
Rachel.Huey@northerntrust.hscni.net 
Sara Gardner (NHSCT) 
Sara.Gardner@northerntrust.hscni.net 
Anita Hogg (NHSCT) 
Anita.Hogg@northerntrust.hscni.net 
Conor McQuillan (NHSCT) 
Conor.McQuillan@northerntrust.hscni.net 
Sarah McLaughlin (MEAAP) 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Mid & East Antrim Area Partnership 
(MEAAP) 18 Queen Street, 
Ballymena, BT42 2BD 
Sarah.McLaughlin@meaap.co.uk  
Rosaliene Donaldson (MEAAP) 
Rosaliene.donaldson@meaap.co.uk  
Catriona O'Boyle (MEAAP) 
Catriona.OBoyle@meaap.co.uk 
Ellen Nixon 
Ellen.nixon@meaap.co.uk 
Úna McNaughton (MEAAP) 
una.mcnaughton@meaap.co.uk 
Deirdre McCloskey  
Deirdre.mccloskey@meaap.co.uk 
Jeanette Van Der Merwe (MEAAP) 
projects@meaap.co.uk 
 
Nicola Platt (MEAPP) 
nicola.platt@meaap.co.uk 
EREVNITIKO IDRIMA P.L. (UNRF), 
established in METOCHIOU 66 
EGKOMI, NICOSIA 
2407, Cyprus. 
Constandinos X. Mavromoustakis 
mavromoustakis.c@unic.ac.cy 
Andreas Andreou (UNRF) 
andreou.andreas@unic.ac.cy  
Costas Constantinou (UNRF) 
constantinou.c@unic.ac.cy 
FUNDACION CENTRO DE 
TECNOLOGIAS DE INTERACCION 
VISUAL Y 
COMUNICACIONES VICOMTECH 
(VICOM), established in PASEO 
MIKELETEGI PARQUE TECNOLOGICO 
DE MIRAMON 57, DONOSTIA SAN 
SEBASTIAN 20009, Spain. 
Nekane Larburu Rubio (VICOM) 
nlarburu@vicomtech.org  
Jon Kerexeta Sarriegi (VICOM) 
jkerexeta@vicomtech.org 
Meritxell García Perea (VICOM) 
mgarciap@vicomtech.org  
TREE TECHNOLOGY SA (TREE), 
established in DE LA POMARADA 76, 
SIERO 33429, Spain. 
Tatiana Silva (TREE) 
tatiana.silva@treetk.com 
Esteban Fabello González 
esteban.fabello@treelogic.com 
GNOMON Informatics SA 
(GNOMON), established in ANTONI 
TRITSI 21, Thessaloniki 57001, 
Greece. 
Fotis Gonidis (GNOMON) 
f.gonidis@gnomon.com.gr>;  
Korina Papadopoulou (GNOMON) 
k.papadopoulou@gnomon.com.gr  
EDGENEERING LDA (EDGE), 
established in AVENIDA INFANTE D 
HENRIQUE NO 2 CENTRO 
Barbara Guerra (EDGE) 
barbara@edgeneering.eu) 
Marco Manso (EDGE) 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
EMPRESARIAL DO OESTE, CALDAS DA 
RAINHA 2500 218, Portugal. 
marco@edgeneering.eu 
FRAUNHOFER-GESELLSCHAFT ZUR 
FOERDERUNG DER ANGEWANDTEN 
FORSCHUNG E.V. (Fraunhofer), 
established in HANSASTRASSE 27C, 
MUNCHEN 80686, Germany. Acting 
as legal entity for and on behalf of its 
Fraunhofer Institute for 
Technological Trend Analysis INT 
Sonja Grigoleit (FRAUNHOFER) 
sonja.grigoleit@int.fraunhofer.de 
UNIVERSITY OF ULSTER (Ulster), 
established in CROMORE ROAD, 
COLERAINE BT52 1SA, United 
Kingdom. 
Dewar Finlay 
d.finlay@ulster.ac.uk 
Raymond Bond 
rb.bond@ulster.ac.uk  
Susan Quinn 
s.quinn1@ulster.ac.uk  
Mark Donnelly 
mp.donnelly@ulster.ac.uk  
Jim McLaughlin 
jad.mclaughlin@ulster.ac.uk 
Shirley Davey 
s.davey@ulster.ac.uk  
NATIONAL UNIVERSITY OF IRELAND 
MAYNOOTH (NUIM), established in 
CO KILDARE, MAYNOOTH, Ireland 
Richard Lombard Vance (NUIM) 
Richard.lombardvance@mu.ie  
Deirdre Desmond (NUIM) 
Deirdre.desmond@mu.ie  
Rebecca Maguire (NUIM) 
Rebecca.maguire@mu.ie  
Health Economist 
Dr Claire Scullin 
Claire.scullin@northerntrust.hscni.net  
Pilot leader centre 
Medicines Optimisation and Innovation Centre, Pine 
House, Antrim Area Hospital Site, Bush Road, 
Antrim, BT41 2RL 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Committees and oversight 
This medicine control and optimisation pilot study is within Work Package (WP) 6 of the overall 
SHAPES Innovation Action. WP6 will hold meetings independently of this pilot study. Likewise, the 
parties involved in this pilot will be involved in other work packages within the SHAPES programme 
and fall outside the remit of this protocol.  
Pilot Management Group 
The Pilot Management Group (PMG) will typically host a monthly meeting. Key attendees are the 
Chief Investigator, relevant project managers (MOIC/NHSCT), representatives from EU pilot sites. 
Other attendees e.g., technical partners, Sponsor representative, funder representative, WP6 leader 
may be invited at the discretion of the Chief Investigator. Attendance and action minutes will be 
recorded. 
 
Other relevant committees 
 
The General Assembly (GA) is the ultimate decision-making body of the SHAPES consortium. 
 
The Project Management Board (PMB) is the supervisory body for the execution of the Project, 
which shall report to and be accountable to the General Assembly. 
 
The Executive Management Team assists the PMB and the Coordinator. The Coordinator is the 
legal entity acting as the intermediary between the Parties and the Funding Authority. 
 
The Ethics Advisory Board (EAB) is a consultative body to help ensure and strengthen the robust 
ethical standards of the SHAPES project and to support the consortium on any ethical issues that 
may arise. 
 
 
 
 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
2. Introduction 
2.1 Background and rationale 
People who are aged 65 years and older account for more than one fifth (20.6%) of the population of 
the European Union [1]. By 2100, this proportion is projected to rise to almost a third (31.3%) of the 
EU population. Conversely, the proportion of EU citizens who describe themselves as being in ‘good’ 
or ‘very good’ health is falling and varies considerably between member states (ranges between 
43.4% and 83.8%) [2]. Naturally, being in ‘good health’ is not only of value to the individual (better 
quality of life, improved wellbeing, greater social participation), but it is also important for societal 
and economic growth [2]. 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. Integrated care focuses on the needs of the recipient of care, rather 
than each condition in silos — coordinating diagnosis and treatment between different therapeutic 
areas and specialties, and between health sectors. The benefits of integrated care models are clear 
(improved outcomes, established chains of prevention, diagnosis, treatment and care across the 
system); still, the complexity of health and care systems in individual countries and regions adds to 
the challenge.  
The location of care delivery will also need to adapt to implement a truly integrated care approach 
to healthcare — 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. Whereas much of this type of care can be delivered at home by community 
nurses, or allied health professionals, who coordinate with the individual’s other clinicians, it is often 
not logistically or economically possible to provide such services to all those who need them. The 
use of information and communication technologies (eHealth) offers opportunities to support and 
enhance home care. With the right eHealth technology, changes in a patient’s condition can be 
potentially recognised at an early stage and treatment can be quickly adjusted — resulting in better-
managed conditions and fewer hospitalisations.  
Health literacy and individual involvement will be key elements in the successful introduction of 
eHealth into the health and social care system. Citizens, including older individuals, must be seen as 
custodians of their own health [3], thus emerging technologies need to be both user-friendly and 
empowering.  
Specifically designed ICT-based assistive technologies may be of great benefit to older individuals 
who are increasingly at risk of frailty pertaining to mobility, vision, hearing and cognitive 
performance. Developments in ICT-based home care, including ways of monitoring wellbeing and 
providing a secure home environment, as well as key emerging technologies on robotics and sensors 
open up the concept of ‘Ambient Intelligence’ and offer the potential for different environments 
(i.e., at home, in the street, during transportation,) to embed intelligence that helps with everyday 
life. To date, initiatives to achieve traction in this area have been modest, with experiments involving 
advanced ICT services supporting health and care through small-scale, localised initiatives. 
The Smart & Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation 
Action intends to build, pilot and deploy a large-scale, EU-standardised open access platform. The 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
integration of a broad range of technological, organisational, clinical, educational and societal 
solutions seeks to facilitate long-term healthy and active ageing and the maintenance of a high-
quality standard of life. Mediated by technology, in-home and local community environments 
interact with health and care networks contributing to the reduction of costs, hospitalisations and 
institutional care. 
SHAPES intends to build an interoperable Platform integrating smart digital solutions to collect and 
analyse older individuals’ health, environmental and lifestyle information, identify their needs and 
provide personalised solutions that uphold the individuals’ data protection and trust. 
Standardisation, interoperability and scalability of the SHAPES Platform aims to increase efficiency 
gains in health and care delivery across Europe, bringing improved quality of life to older individuals, 
their families, caregivers and care service providers. SHAPES large-scale piloting campaign will 
engage over 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 involving 
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-effective, interoperable and reliable innovations 
capable of effectively supporting healthy and independent living of older individuals both within and 
outside the home.  
These seven themes are as follows:  
Pilot Theme 1 Smart Living Environment for Active Ageing at Home  
Pilot Theme 2: Improving In-Home and Community-based Care Services 
Pilot Theme 3: Medicine Control and Optimisation 
Pilot Theme 4: Psycho-social and Cognitive Stimulation Promoting Wellbeing 
Pilot Theme 5: Caring for Older Individuals with Neurodegenerative Diseases 
Pilot Theme 6: Physical Rehabilitation at Home 
Pilot Theme 7: Cross-border Health Data Exchange Supporting Mobility and Accessibility for Older 
Individuals 
The Medicines Optimisation Innovation Centre (MOIC), which is hosted by the Northern Health and 
Social Care Trust (NHSCT) in Northern Ireland. Northern Ireland 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: ‘Medicine 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. The anticipated benefits of this highly personalised approach 
to delivering healthcare is to promote safer and more effective use of medicines in the home, thus 
improving the health outcomes and quality of life of the target population [4]. Data collected from 
participants will provide validation of a heart failure decompensation algorithm which may, in 
future, be used to detect precursor signs indicating the deterioration or serious complications of the 
older individual’s condition. Within this pilot theme there are multiple ‘use cases’ each deploying 
and evaluating different digital solutions according to the type of support required. Four use-cases 
will be used to evaluate this pilot theme. This protocol describes the piloting of one use case 
(Supporting multi-morbid older individuals) in NHSCT. 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
2.2 Hypothesis 
This study will test the hypothesis that the SHAPES platform and Digital Solutions are capable of 
providing opportunities for supporting medicine control and optimisation in older people with 
multiple chronic health conditions. 
 
2.3 Objectives 
Primary objective 
 
To investigate user engagement with the SHAPES app and Digital Solutions  
 
Secondary objectives 
The following objectives are specific to the ‘Supporting multi-morbid older individuals’ use case: 
 
To validate the capability of the SHAPES platform and Digital Solutions to; 
o  implement a personalised approach to achieve safe and effective use of medicines 
at home. 
 
o achieve better patient outcomes by initiating, developing and sharing best practice 
with regards to medicines use. 
 
o address and improve deficiencies with adherence to medicines and treatments. 
 
o identify associations between precursor signs of deterioration and unscheduled 
healthcare resource use.  
 
o improve data collection to develop predictive algorithms for heart failure 
decompensation. 
 
o improve older individuals’ quality of life. 
 
 
To explore the integration of the SHAPES platform and Digital Solutions to align with current 
and developing care pathways. 
 
 
To explore user trust and acceptance of the SHAPES platform and Digital Solutions. 
 
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; 
o support and extend healthy and independent living for older individuals who are 
facing permanently or temporarily reduced functionality and capabilities. 
 
o improve the older individuals’ health outcomes and quality of life. 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
o gain the older individuals’ trust and acceptance. 
 
o gain the care professionals’ trust and acceptance.  
 
o contribute to the reduction of the workload of medical professionals. 
 
o deliver efficiency gains in health and care delivery across Europe. 
 
2.4 Pilot design 
This is a non-randomised, single-armed, cross-sectional interventional pilot study with an optional 
qualitative interview component. The pilot will aim to recruit 30 participants who will be NHSCT 
service users. 
Separate qualitative interviews will be held with up to 5 clinical leads employed by the Northern 
Health and Social Care service in Northern Ireland. 
 
3. Methods 
3.1 Study setting 
The pilot will be conducted with service users from the Northern Health and Social Care Trust 
(NHSCT) who reside in their own home or supported living environment. Additionally, interviews will 
be conducted with clinical or policy leads in the NHSCT. 
3.2 Eligibility criteria 
Service user inclusion criteria 
At point of consent; 
 
Northern Health and Social Care Trust service user 
 
≥60 years  
 
Diagnosed with heart failure and/or diabetes mellitus 
 
 If diagnosed with diabetes mellitus (and not heart failure), treatment includes regular 
monitoring of blood glucose 
 
Lives at home or in supported living accommodation (category 1 or 2).  
o Category 1 - self-contained accommodation for the more active elderly, which may 
include an element of scheme supervisor support and/or additional communal 
facilities 
o Category 2 - scheme supervisor supported self-contained accommodation for the 
less active elderly, which includes the full range of communal facilities 
 
Has stable self-reported Wi-Fi connection at home 
 
Has access to an appropriate android smartphone or tablet  
o Android device running version 6 or above; supports Wi-Fi; supports BLE; front 
facing camera for facial recognition 
 
Self-reported stable disease state, the participant feels well enough to take part in the pilot 
 
Self-reported confident user of smartphone/tablet 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Service user exclusion criterion 
At point of consent; 
 
Participant report of cognitive impairment 
 
Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram) 
 
Allergy to rubber products 
HSC staff inclusion criterion 
 
Knowledge of patient care pathways 
 
Employed by the Northern Health and Social Care service in Northern Ireland 
HSC staff exclusion criteria 
 
Unwilling or unable to provide consent 
 
3.3 Intervention 
The intervention being piloted in this study is a novel system of supporting older individuals with 
multiple long-term conditions to self-manage their chronic conditions through the daily use of a 
digital health product that can also facilitate the remote monitoring of a person’s health status. 
The goals of the intervention are to help people self-monitor their health conditions, physiological 
parameters and medicines adherence to promote safer and more effective use of medicines in their 
own home. In future, the intervention will also facilitate the remote monitoring of people by health 
and social care practitioners and use artificial intelligence (AI) algorithms to predict deterioration in a 
person’s health status. However, this functionality will not be investigated in the present study.  
Participants will be asked to download the SHAPES app to an appropriate smartphone or tablet. 
Mock-up images of the app are provided as a supporting document. Four CE-marked, Bluetooth-
enabled devices, specifically a body composition monitor (OMRON VIVA Smart Scale), glucometer 
(Roche Accu-chek Instant), blood pressure monitor (OMRON M7 Intelli IT) and pulse oximeter 
(Beurer GmbH PO60 Bluetooth pulse oximeter), will also be provided, as appropriate, to participants 
to use at home. Participants diagnosed with heart failure will be provided with the body composition 
monitor (OMRON VIVA Smart Scale), blood pressure monitor (OMRON M7 Intelli IT) and pulse 
oximeter (Beurer GmbH PO60 Bluetooth pulse oximeter). Participants diagnosed with diabetes will 
be provided with the glucometer (Roche Accu-chek Instant) and given the option to use the other 
devices according to preference. Participants will be encouraged to use the devices to take daily 
readings of their weight, blood pressure, heart rate and oxygen saturation, and readings of their 
blood glucose as per their existing diabetes care plan (if applicable). The readings are electronically 
transferred to the SHAPES app via Bluetooth. Participants can view their data via the app and have 
the ability to enter readings manually if required. Participants will also be encouraged to complete a 
daily survey containing questions about their health status (participants with heart failure only), and 
a weekly survey about their use of medicine. The participant’s medication regimen will be uploaded 
to the app by researchers and will be available to view both as a comprehensive list of all medicines, 
and a daily list to serve as a reminder for what has to be taken that day. Participants will be asked via 
the app on a weekly basis if any changes had been made to their treatment that week so that their 
medication regimen can be amended accordingly.  

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Participants will receive one-on-one, face-to-face introduction to the app and training on how to use 
both it and the connected medical devices. A user manual will contain detailed step-by-step 
supportive guidance and information, and will be provided to participants in hard-copy format for 
reference by participants during the pilot. There will be a run-in period of approximately one week 
wherein the participant can familiarise themselves with the app and liaise with the researchers to 
troubleshoot any problems they may be experiencing with the technology. Participants will be asked 
to use the app and connected devices for 12 weeks. Researchers will contact participants by 
telephone at the end of week 1, if there are three or more consecutive days were no data has been 
received (up to a maximum if four times during the pilot) and monthly (if required) thereafter. These 
telephone contacts are to enable the researchers to support participants with their use of the 
technology and troubleshoot any issues they may be experiencing (no health advice or clinical 
support will be provided by the researchers. If participants have any health concerns they will be 
encouraged to contact their specialist care team).  
All data entered or transferred into the SHAPES app (i.e., clinical readings, survey responses) is 
pseudonymised and will be stored in the technical partners’ (EDGE and GNOMON) servers and then 
uploaded to the SHAPES big data platform. Selected data is then processed by two further SHAPES 
digital solutions; a heart failure decompensation risk prediction algorithm (VICOM) and an analytic 
tool that generates personalised dynamic thresholds for participants’ clinical parameters (TREE). 
These digital solutions have not yet been validated or CE-marked for use as medical devices. 
Therefore, the outputs will not be used to inform clinical care, but rather to determine whether the 
digital solutions are capable of producing outputs reliably using the available data, and to indicate if 
there are any associations between the risk scores generated and the participants’ use of 
unscheduled care. 
Participants’ data and outputs from VICOM and TREE digital solutions will be uploaded to a browser-
based researcher dashboard. Researchers will be able to view each participant’s clinical and survey 
data, and manage participants’ medication regimens as needed. Researchers will view the available 
data and information for purposes of monitoring usage of the app and inputting changes to 
medication regimens only.  
 
3.4 Outcomes 
Primary outcome 
Participants’ engagement with the SHAPES app during the pilot as defined by the number of times 
the app is opened per day over three months. 
Secondary outcomes 
 
Participants’ user experience with the SHAPES app as measured using the User Experience 
Questionnaire –short version (UEQ-S) 
 
Usability of the SHAPES app as measured using the System Usability Scale 
 
Number and rate of successful registrations of each clinical parameter per participant, per day 
(heart rate, blood pressure, weight, oxygen saturation, blood glucose)  
 
Number and rate of control limits (upper and lower) successfully generated by the ‘Vitals 
Control’ analytic tool per person (rate defined as number of pairs of limits generated per week 
during the pilot) 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
 
Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully 
generated per person (rate defined as number of scores generated per week during the pilot) 
 
Change in hospitalisation rate per person (hospitalisations/month) and A&E attendance rate 
(attendance/month) three months prior to baseline compared with 3 months during the pilot 
 
Participants’ self-reported medication adherence as measured using the Medication Adherence 
Report Scale (MARS) at baseline and at the end of the pilot 
 
Participants’ beliefs about medicines as measured using the Belief’s about Medicines 
Questionnaire (BMQ) at baseline and at the end of the pilot 
 
Correlation between participants’ self-reported medication adherence and beliefs about 
medicines 
 
Number and rate (score/week) of heart failure decompensation prediction (HFPred) risk scores 
successfully generated per person during the pilot 
 
Correlation between HFPred scores and unscheduled care during the pilot (unscheduled care 
defined as composite of hospitalisations, A&E attendances, specialist contacts, out-of-hours 
contacts) 
 
Health-related quality of life as measured using the EQ-5D-5L questionnaire (ref) at baseline and 
at the end of the pilot 
 
Exploration of healthcare practitioners’ views on integration and alignment of the SHAPES 
platform and Digital Solutions with current care pathways  
 
Exploration of healthcare practitioners’ views about their trust and acceptance of the SHAPES 
platform and Digital Solutions 
 
Exploration of participants’ views about their trust and acceptance of the SHAPES app. 
 
Exploration of user engagement behaviors 
Tertiary outcomes 
The following outcomes align with the general purposes of the SHAPES large-scale piloting campaign 
and data will be harmonised with outcome data from all pilots in the campaign: 
 
Participants’ self-efficacy as measured using the general self-efficacy scale 
 
Participants’ extent of social support as measured using the Oslo Social Support Scale (OSSS-3) 
 
Participants’ health literacy as measured using the Single-item Health Literacy Measure (HLM1) 
 
Participation in society as measured using non-validated participation questions 
 
Participants’ quality of life as measured using the WHOQOL-BREF 
 
Health-related quality of life as measured using the EQ-5D-5L 
 
Usability of the SHAPES app as measured using the System Usability Scale 
 
Technology Acceptance  
 
Exploration of participants’ views about their trust and acceptance of the SHAPES platform and 
Digital Solutions 
 
Exploration of healthcare practitioners’ views about their trust and acceptance of the SHAPES 
platform and Digital Solutions 
 
Change in health service utilisation for unscheduled care related to heart failure and diabetes as 
measured by: 
• 
Number of hospitalisations 
• 
A&E attendances  
• 
Out of hours contacts 
• 
Contacts with specialist services 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
 
Economic impact of the intervention as measured by comparing the cost of the intervention 
(devices, SHAPES platform and digital solutions; staffing) versus the cost of unscheduled care 
related to heart failure and diabetes during the pilot.  
 
 
Table 1: Table of outcomes mapped to objectives of pilot 
Objective 
Outcome measure 
 
Timepoint(s) of 
evaluation of outcome 
measure (if applicable) 
To investigate user 
engagement with the 
SHAPES app and 
Digital Solutions  
Participants’ engagement with the SHAPES 
app during the pilot as defined by the 
number of times the app is opened per day 
per person over three months. 
 
End of pilot  
User experience as measured using the user 
experience questionnaire –short version 
(UEQ-S) 
End of pilot 
System Usability Score 
End of pilot  
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions to 
implement a 
personalised 
approach to achieve 
safe and effective use 
of medicines in 
homes. 
Number and rate of successful registrations 
of each clinical parameter per participant, 
per day  (heart rate, blood pressure, 
weight, oxygen saturation, blood glucose)  
End of pilot 
Number and rate of control limits (upper 
and lower) successfully generated by the 
‘Vitals Control’ analytic tool per person 
(rate defined as number of pairs of limits 
generated per week during the pilot) 
End of pilot 
Number and rate of heart failure 
decompensation prediction (HFPred) risk 
scores successfully generated per person 
(rate defined as number of scores 
generated per week during the pilot) 
End of pilot 
Number and rate of views of medication list 
(rate as defined as number of views per 
week during the pilot) 
End of pilot 
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions to 
achieve better patient 
outcomes by initiating, 
developing and 
sharing best practice 
with regards to 
medicines use. 
Change in use of unscheduled care related 
to heart failure and diabetes as measured 
by: 
 
Rate of hospitalisation 
 
 
Rate of A&E attendance 
 
 
 
 
3 months prior to baseline 
and end of pilot 
3 months prior to baseline 
and end of pilot 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions to 
address and improve 
deficiencies with 
adherence to 
medicines and 
treatments. 
Medication Adherence Report Scale (MARS) 
Baseline and end of pilot 
Beliefs about Medicine Questionnaire 
(BMQ) 
Baseline and end of pilot 
Correlation between participants’ self-
reported medication adherence and beliefs 
about medicines 
After pilot 
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions 
improve data 
collection to develop 
predictive algorithms 
for heart failure 
decompensation. 
Number and rate of heart failure 
decompensation prediction (HFPred) risk 
scores successfully generated with 
complete data collection per person (rate 
defined as number of scores generated per 
week during the pilot) 
End of pilot 
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions to 
identify associations 
between precursor 
signs of deterioration 
and unscheduled 
healthcare resource 
use.  
Correlation between HFPred scores and 
unscheduled care during the pilot 
Association between HFPred scores and 
unscheduled care during the pilot 
(unscheduled care defined as composite of 
hospitalisations, A&E attendances, 
specialist contacts, out-of-hours contacts) 
After pilot 
To validate the 
capability of the 
SHAPES platform and 
Digital Solutions to 
improve older 
individuals’ quality of 
life 
EQ-5D-5L 
 
Baseline and end of pilot 
 
To explore the 
integration of the 
SHAPES platform and 
Digital Solutions to 
align with current and 
developing care 
pathways. 
Exploration of healthcare practitioners’ 
views on integration and alignment of the 
SHAPES platform and Digital Solutions with 
current care pathways  
 
During or after pilot 
To explore user trust 
and acceptance of the 
SHAPES platform and 
Digital Solutions. 
Exploration of participants’ views about 
their trust and acceptance of the SHAPES 
app. 
 
End of pilot 
Exploration of user engagement behaviors 
After pilot 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
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 
General Self-Efficacy Scale 
Baseline; End of pilot; 3-
month follow-up 
Oslo Social Support Scale (OSSS-3) 
 
Baseline; End of pilot; 3-
month follow-up 
Health literacy as measured using the 
Single-item Health Literacy Measure 
(HLM1) 
Baseline; End of pilot; 3-
month follow-up 
Participation measure (non-validated) 
Baseline; End of pilot; 3-
month follow-up 
To validate the 
capability of the 
SHAPES Platform and 
Digital Solutions to 
improve the older 
individuals’ health 
outcomes and quality 
of life 
WHOQOL-BREF 
 
Baseline; End of pilot; 3-
month follow-up 
EQ-5D-5L 
Baseline; End of pilot; 3-
month follow-up 
To validate the 
capability of the 
SHAPES Platform and 
Digital Solutions to 
gain the older 
individuals’ trust and 
acceptance 
System Usability Score 
 
End of pilot 
 
Technology Acceptance measure (non-
validated)  
End of pilot  
To validate the 
capability of the 
SHAPES Platform and 
Digital Solutions to 
gain the care 
professionals’ trust 
and acceptance  
Exploration of healthcare practitioners’ 
views on integration and alignment of the 
SHAPES platform and Digital Solutions with 
current care pathways  
 
After pilot 
To validate the 
capability of the 
SHAPES Platform and 
Digital Solutions to 
contribute for the 
reduction of the 
Change in health service utilisation for 
unscheduled care related to heart failure 
and diabetes as measured by: 
 
 
Number of hospitalisations 
3 months prior to baseline 
and end of pilot 
 
A&E attendances  
3 months prior to baseline 
and end of pilot 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
workload of medical 
professionals 
 
Out of hours contacts 
3 months prior to baseline 
and end of pilot 
 
Contacts with specialist services 
3 months prior to baseline 
and end of pilot 
To validate the 
capability of the 
SHAPES Platform and 
Digital Solutions to 
deliver efficiency gains 
in health and care 
delivery across Europe 
 
Economic impact of the intervention as 
measured by comparing the cost of the 
intervention (devices, SHAPES platform and 
digital solutions; staffing) versus the cost of 
unscheduled care related to heart failure 
and diabetes during the pilot.  
 
After the pilot 
 
 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
3.5 Participant timeline 
 
 
Figure 1: Service user participant timeline 
 
3.6 Sample size 
The target sample size for this pilot study is 30 NHSCT service user participants and up to 5 HSC staff. 
These sample sizes were selected pragmatically to be as representative as possible of the target 
population, large enough to provide valid answers and within the scope of the resources available. 
 
3.7 Recruitment 
Recruitment strategy 
Heart failure and diabetes are two of the most common chronic conditions affecting older people in 
Northern Ireland which is one of the reasons why we have included them in this pilot. People with 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
these conditions are encouraged to learn more about their conditions and self-management is 
promoted to help maximise health and wellbeing.  
 
No financial incentives will be provided for participating in this pilot. 
Service user screening procedure 
Potential participants will either be identified from hospital in-patient and clinic lists in Antrim Area 
Hospital by their direct care team or by a project officer from Mid and East Antrim Agewell 
Partnership (MEAAP). Alternatively they may contact the research team directly from a recruitment 
poster or the research team may contact potential participants if consent to contact is obtained.  
Northern Health and Social Care Trust (NHSCT) 
Screening Members of the direct care team will screen their patient lists for potentially eligible 
participants.  
Invitation The first communication about the pilot will be from the direct care team at the hospital 
or via a poster advertising the SHAPES pilot that will be displayed on information boards located 
within NHSCT Hospitals and on official NHSCT, MEAAP and MOIC social media feeds. The poster will 
direct potential participants interested in the pilot to contact the research team directly. 
Alternatively, the direct care team may invite potentially eligible participants to participate in-person 
at a clinic/hospital attendance, over the phone or via a written invitation (electronic or paper).  
Information sheets Information sheets will be provided to potentially eligible participants in-person 
or via post or email either by the direct care team or the research team (if contacted directly or 
consent to contact is documented). A minimum of 24 hours will be provided to allow time to 
consider the information provided before consent is obtained.  
Consent to contact Verbal consent to be contacted may be provided by potential participants to 
their direct care team to allow the provision of contact name and telephone number of the potential 
participant to the research team. This will be documented by the direct care team. The research 
team may then attempt to contact the potential participant by phone. 
Eligibility confirmation Eligibility may be confirmed by the direct care team. The research team may 
also confirm eligibility if potential participants make direct contact with them or if participants have 
provided consent to contact. Eligibility may be confirmed either in-person or over the phone and 
documented. 
Consent Eligible participants will be required to provide written consent. The direct care team may 
obtain consent. The research team may obtain consent if contacted directly by the potential 
participant or if verbal consent to contact has been received. Voluntary, informed consent for all 
participants may be obtained in-person or remotely with the following format of signatures 
collected where appropriate: 
• 
Handwritten 
• 
Typewritten  
• 
Scanned  
• 
An electronic representation of a handwritten signature  
• 
Handwritten signature posted to research personnel  

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
 
Mid and East Antrim Agewell Partnership (MEAAP) 
Screening MEAAP project officers will screen their client lists for potentially eligible participants. 
Potentially eligible participants may be contacted in-person, over the phone or via a written 
invitation (electronic or paper). 
Invitation The first communication about the pilot will be from a project officer from MEAAP. This 
may occur in-person, over the phone or a written invitation (electronic or paper).  
Information sheets If potential participants are interested in the pilot their MEAAP project officer or 
member of the research team (if consent to contact obtained) will provide further information about 
the pilot. A minimum of 24 hours will be provided to allow time to consider the information 
provided before consent is obtained. 
Consent to contact Verbal consent to be contacted may be provided by potential participants to 
their MEAAP project officer to allow the provision of contact name and telephone number of the 
potential participant to the NHSCT research team. This will be documented by the project officer. 
The research team may then attempt to contact the potential participant by phone. 
Eligibility confirmation Eligibility may be confirmed by the MEAAP project officer. The research team 
may also confirm eligibility if potential participants make direct contact with them or if they have 
provided consent to contact. Eligibility may be confirmed either in-person or over the phone and 
documented. 
Consent Eligible participants will be required to provide written consent. The project officer may 
obtain consent. The research team may obtain consent if contacted directly by the potential 
participant or if verbal consent to contact has been received. Voluntary, informed consent for all 
participants may be obtained in-person or remotely with the following format of signatures 
collected where appropriate: 
• 
Handwritten 
• 
Simple electronic signature (e.g. tickbox and declaration, typed name and date) Scanned  
• 
An electronic representation of a handwritten signature  
• 
Handwritten signature posted to research personnel  
 
Withdrawal of consent 
Participants can withdraw from the study at any point, no reason needs to be provided, however, 
the participant will be asked if they would like to state a reason for withdrawal.  
Clarification will be sought as to whether the participant would like to withdraw all data or if data 
provided up to the point of withdrawal may be retained and used in the analysis and description of 
the pilot cohort.  
The following details will be noted upon withdrawal of consent; date, reason (if provided), whether 
consent for a follow-up interview or consent to use data until date of withdrawal remains. 
 
HSC staff recruitment 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
A list of appropriate professionals will be identified from the research team’s knowledge and 
contacts. An invitation email containing information about SHAPES and a request to conduct an 
interview and demonstrate the intervention will be sent. If the request is accepted an information 
sheet will be provided and the research team will obtain consent. Voluntary, informed consent for 
all participants may be obtained in-person or remotely with the following format of signatures 
collected where appropriate: 
• 
Handwritten 
• 
Simple electronic signature (e.g. tickbox and declaration, typed name and date) Scanned  
• 
An electronic representation of a handwritten signature  
• 
Handwritten signature posted to research personnel 
 
3.8 Data collection, management and analysis 
3.8.1 Service user data collection methods 
The majority of data collection will be conducted remotely. The exception to this is the face-to-face, 
one-to-one introduction to the app and devices. This will be conducted in person if the current local 
COVID-19 situation permits and this is the participant’s preference. The procedures below may be 
completed in person or remotely depending on the current COVID guidelines and participant 
preference. 
Service user prior to baseline procedures 
 
Screening 
 
Eligibility confirmation 
 
Informed consent 
 
Training on use of SHAPES app and connected devices 
 
Run-in, familiarisation with devices 
 
Contact details — name, address, email, phone number, alternative contact name and 
phone number, Health and Care number 
 
Service user baseline procedures 
 
Questionnaires — Barthel Index, Gijon Scale, EHFS, MARS, BMQ, EQ-5D-5L, GSES, OSSS-3, 
HLM1, participation measure, WHOQOL-BREF  
 
Medical history data — height, weight, left ventricular ejection fraction, heart rhythm, 
implanted devices, medical conditions, heart failure stage, dyspnoea level, smoking status, 
leg pain symptom question 
 
Demographic data — including DOB, education, sex, marital status, occupational status, 
caregiver status, housing details 
 
Technical data — device monitoring details e.g. model, manufacturer, serial number and 
preferred time of day for reminders/questionnaires, make and model of the participants 
own smartphone/tablet 
 
Laboratory results — urea, creatinine, sodium, potassium, haemoglobin, cholesterol, eGFR, 
HbA1c, ACR, urine creatinine, urinary albumin-creatinine ratio 
 
Unscheduled care — hospitalisations (previous 3 months), and previous month hospital 
readmissions, A&E attendances, out of hours care, specialist service contacts, emergency 
ambulance call outs 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
 
Current prescribed medication — name, frequency, strength, chronic or as required, stop 
date if stopped during the pilot, start date if started during the pilot. 
 
Service user study visits and procedures 
 
During the pilot, the participant will be asked to record the following at least once daily, as 
appropriate, via the SHAPES app; blood pressure, heart rate, oxygen saturation, weight 
(which will include body mass index, body fat, visceral fat, skeletal muscle, basal metabolic 
rate). 
 
Participants diagnosed with diabetes and monitoring blood glucose regularly will be 
requested to record their blood glucose with the same frequency as directed by their doctor 
on the SHAPES app.  
 
Participants diagnosed with heart failure will be asked a series of daily questions about their 
heart failure symptoms administered via the SHAPES app. 
 
All participants will be asked about their adherence to medication with a weekly MARS 
questionnaire administered via the SHAPES app. 
 
During the pilot, the patient may view their medication list 
 
Unscheduled care updates — any updates to baseline hospitalisations, hospital 
readmissions, A&E attendances, out of hours care, specialist service contacts, emergency 
ambulance call outs recorded from medical notes 
 
Prescribed medication updates — any updates to prescribed medications notified by 
participant 
 
Tracking data — log data on how the participant uses the SHAPES app e.g., date/time of 
usage, what functionalities were accessed 
 
Adverse events — date, start time, injury description, incident description, action taken, 
location of incident (private home or healthcare facility) 
 
Researchers will document any contact received/provided regarding support required to 
facilitate the pilot (date, duration, reason) 
 
Service user end of pilot visit (+14 days) 
 
Questionnaires — UEQ-S, SUS, MARS, BMQ, EQ-5D-5L, GSES, OSSS-3, HLM1, participation 
measure, WHOQOL-BREF, technology acceptance measure 
 
Participant may participate in an interview at this time or a separate date may be 
accommodated. 
 
Demographic data — marital status, occupational status, caregiver status, housing details 
 
Service user follow-up study visits and procedures 
 
If an interview is to be conducted this may occur at a mutually convenient time after the 
intervention has been completed. 
 
3 month follow-up data collection (+/- 7days): 
 
Questionnaires — EQ-5D-5L, GSES, OSSS-3, HLM1, participation measure, WHOQOL-BREF 
 
3.8.2 Healthcare professional data collection 
The interviews carried out with health care professionals may be conducted in person or remotely 
using video-conferencing software, e.g., Zoom. 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
HSC staff prior to baseline procedures 
 
Screening 
 
Eligibility confirmation 
 
Informed consent 
 
HSC staff interview 
 
A mutually convenient time will be sought to complete an interview. The interview will 
include background on the SHAPES innovation action, information on the intervention 
applied and demonstration of data collection (may include SHAPES front-end app interface 
and researcher interface).  
 
A semi-structured interview guide will guide the conversation which may be recorded (audio 
and video).  
 
The interview will be transcribed and thematic analysis conducted. 
 
3.8.3 Data collection tools 
Data collection for the service user will be documented on to a case report form (CRF). Paper 
questionnaires will form part of the CRF and the CRF will be the source for questionnaires. The 
source for all data points can be found in the data plan. The CRF will then be transcribed onto an 
online database using Microsoft Excel and analysed using Microsoft Excel and IBM SPSS Software 
this will be stored on NHSCT computers behind the NHSCT firewall. Specific data will be securely 
shared with other SHAPES partners and appropriate Data Processing Agreements will be in place. 
Data collection for the interviews with healthcare professionals may be audio and visually recorded. 
This will be completed either by using videoconferencing software e.g., Zoom or using a Dictaphone. 
Interviews will be transcribed either manually or using software and the transcript validated by a 
second researcher.  
3.8.4 Adverse incidents 
It is very unlikely that any adverse incidents will occur in this pilot, however if any participant 
spontaneously reports an adverse incident the NHSCT policy ‘Adverse Incident Management Policy 
(including Serious Adverse Incidents)’ NHSCT/17/1102 will be followed. This includes reporting to 
external parties if applicable, e.g., Northern Ireland Adverse Incident Centre. 
Adverse incident definition: Any event or circumstances that could have or did lead to harm, loss or 
damage to people, property, environment or reputation arising during the course of the business of a 
HSC organisation/Special Agency or commissioned service. 
 
If the research team are notified of a product recall regarding the devices used in this pilot the 
participant will be notified as soon as practicable and requested not to use the device. Arrangements 
will be made to physically remove the device and replace it if possible. 
 
Clinicians will not have access to the data collected and participant treatment will not be changed 
due to taking part in this pilot. This is clearly noted in the participant information sheet. If 
participants are concerned in any way about the readings on their devices, they are to follow their 
normal mechanisms for seeking healthcare. 
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
3.8.5 Risks to research staff 
To minimise risks to researchers, the NHSCT policy ‘Lone Worker’ NHSCT/12/471 will be followed 
and appropriate personal protective equipment will used by researchers on home visits to 
participants.  
 
3.8.6 Protocol deviations 
Data collection will be monitored by the research team through the researcher web portal. 
Participants will be contacted via phone after a week of starting the intervention to see if they need 
any assistance. Thereafter the participant will be encouraged to contact the research team if they 
are having any technical difficulties. If no data are uploaded for 3 consecutive days the research 
team may contact the participant to see if there is a technical issue, this may occur a maximum of 4 
times during the pilot. Additionally, if there are significant issues with data collection, participants 
may be contacted monthly to act as a reminder or to troubleshoot any issues that may occur. If the 
participant notifies researchers via the app that there is a change to their medication, the participant 
will be contacted to confirm the change and the app will be updated by researchers. 
 
This pilot is examining the real world use of the SHAPES app and associated clinical devices therefore 
if participants do not enter data as requested in the pilot this will not be documented as a protocol 
deviation, rather this will provide an insight into the usability of this digital solution. 
 
3.8.7 Data management 
Data processed in this pilot will be subject to the Data Protection Act 2018. This is the UK’s 
implementation of the General Data Protection Regulation (GDPR). The NHSCT will be the data 
controller for all data collected during this pilot. The data flow for this pilot is complex (see figure 2) 
and as such multiple Data Processing Agreements will be put in place between the data controller 
(NHSCT) and each SHAPES partner who processes this data.  
Personal data minimization and purpose limitation principles have been followed so that this pilot 
will only process  data  that  is  adequate,  relevant  and  limited  to  what  is necessary to deliver the 
objectives of the pilot. Personal data may be processed only for these purposes.  Only personal data 
strictly necessary to the completion of this pilot will be retained. 
The data collected for this pilot will be contemporaneous and accurate. If a participant withdraws 
from the study, clarification will be sought as to what data may need to be erased. This data will be 
identified and erased without delay. Personal data will be de-identified at the end of the SHAPES 
Innovation Action (Oct 2023). The NHSCT de-identified data set may be retained for a period of five 
years after October 2023 and then deleted.  An anonymous, aggregated dataset will be stored 
indefinitely for future use by researchers. A de-identified, dataset may be shared with other SHAPES 
partners if an appropriate data sharing agreement is in place.  
The data for this pilot will be stored securely. The location of each data point is listed in the data 
plan for this pilot, this document is a working document and will be kept up to date. Personal data 
will be kept in a form which permits identification of data subjects by approved NHSCT staff until 
October 2023. 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
All data in this pilot is traceable using the pilot data plan. This means that the research team are able 
to identify the origin of the data, how it’s processed, where stored and if it has been transferred or 
disclosed to a third party.  
Further details regarding personal data are described in the Data Protection Impact Assessment 
(DPIA), Personal Data Processing Descriptions document and DPIA risk assessment document for this 
pilot. Additionally, a detailed description of all data (including but not limited to personal data) 
collected can be located in the data plan for this pilot. 
 
 
Figure 2: PT3-gen data flow/architecture diagram 
 
3.8.8 Missing data 
Every effort will be made to reduce the potential for missing data, however, if missing data occurs it 
will be coded ‘999’ or if applicable, the missing data protocol for the questionnaire or SHAPES 
protocol will be followed.  
 
The VICOM heart failure prediction algorithm requires a number of data fields to be completed each 
day in order to provide a decompensation risk. If one of these values is missing, no risk prediction 
can be performed. It may be necessary on occasion to populate a participant’s average value, e.g., if 
a participant is bed bound they will find it difficult to provide a daily weight value. These exceptions 
will be documented. If a complete data set is not obtained, data will be imputed. It will be clear to 
the researcher which risk scores are based on fully completed data versus partially completed and 
imputed data. 
 
3.8.9 Data duplication 
Heart rate is collected by the blood pressure monitor and the pulse oximeter. The heart rate 
provided to the VICOM heart failure prediction algorithm will be from the pulse oximeter. 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
3.8.10 Data analysis  
All data will be analysed as outlined in the Data Analysis Plan. Demographic characteristics will be 
summarised and reported to describe the sample population. NHSCT will analyse all data pertaining 
to the primary and secondary outcome measures, and selected tertiary outcomes, listed above 
(Table 1) to determine if the objectives of the pilot have been achieved. Quantitative and qualitative 
data analysis methods will be employed and findings reported. Data pertaining to the tertiary 
outcomes that align with other pilots in the SHAPES pan-European piloting campaign (i.e., 
harmonisation data) will be analysed by the SHAPES coordinators at Maynooth University. In-depth 
analysis of user engagement and cross-comparative analysis of user engagement with qualitative 
data will be performed by SHAPES partners at Ulster University. In addition, the Model for 
Assessment of Telemedicine (MAST) framework will be used to evaluate the effectiveness and 
contribution of the pilot to quality of care. MAST is described as a multidisciplinary process that 
summarises and evaluates information about the medical, social, economic and ethical issues 
related to the use of telemedicine applications.   
3.8.11 Statistical methods 
Where appropriate, descriptive statistics will be reported for all quantitative data (e.g., UEQ-S, 
MARS, BMQ) the mean and standard deviation (SD) will be reported where data are approximately 
normally distributed, and the median and interquartile range (IQR) reported where data are non-
normally distributed. Differences in outcomes measured at baseline and at the end-of-pilot will be 
compared using paired t-test or Wilcoxon Signed Rank test (or appropriate alternative), depending 
on the distribution of the data. Confidence intervals and effect size will be calculated and reported 
to provide an estimation of the size and direction of treatment effect.  
 
4 Ethics and dissemination 
4.1 Research ethics approval 
Approval to conduct the pilot will be sought from a Research Ethics Committee (REC) before the 
start of the pilot. This protocol and all other relevant documents (e.g. participant information sheets, 
consent forms, user manuals etc.) will be submitted alongside an Integrated Research Application 
System (IRAS) form using the appropriate online booking system for REC review.  
The Chief Investigator will notify the REC at the end of the pilot and a final report will be submitted 
to the REC within one year. Should the pilot be terminated prematurely, the REC will be notified and 
informed of the reasons for termination.    
Prior to submission to the REC, this protocol will be reviewed and approved for submission by 
colleagues within the SHAPES consortium. This protocol will receive a high quality peer review by at 
least two independent experts in the field of health services research. Research governance at 
NHSCT will also review the protocol and provide approval for submission as the pilot Sponsor.  
 
4.2 Protocol amendments 
Any substantial amendments that require review by REC will not be implemented until the REC 
grants a favourable opinion for the trial, and all correspondence with the REC will be retained in the 
Trial Master File.  
 

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
4.3 Consent  
All participants will be asked to provide voluntary, informed consent for their participation in the 
pilot. 
 
4.4 End of pilot and termination criteria 
The pilot will be stopped if there is evidence of harm caused to participants due to their involvement 
in the pilot e.g., data breach or device malfunction. 
The end of pilot will be defined as the last participant, last follow-up. 
 
4.5 Confidentiality  
All investigators and pilot site staff will comply with the requirements of the Data Protection Act 
2018 with regards to the collection, storage, processing and disclosure of personal information and 
will uphold the Act’s core principles. The Medicines Optimisation and Innovation Centre research 
team will have up-to-date Good Clinical Practice certification.  
Participants will be pseudonymised on enrolment to the pilot and allocated a SHAPES unique 
identifier (ID). A folder containing the essential information for project management, including 
consent forms, will be retained in a in a locked office on the Antrim Area Hospital Site in Northern 
Ireland. The participant list, linking the participant name to their pseudonymised SHAPES ID, will be 
retained by approved NHSCT staff working on the SHAPES study and stored securely on NHSCT 
servers protected by the NHSCT firewall. 
All information collected in this pilot (identifiable and pseudonymised) will be stored securely on 
NHSCT computers behind the NHSCT firewall. Any hard copies of identifiable (e.g., consent forms) 
and pseudonymised data (e.g., questionnaires) will be stored in a locked office on the Antrim Area 
Hospital site. 
 
Only NHSCT staff and MEAAP staff who are approved to work on the SHAPES project will have access 
to identifiable participant information. Appropriate agreements will be in place to facilitate 
processing of pseudonymised data by other SHAPES partners. 
 
4.6 Declaration of interests 
No conflicts of interest have been declared by any members of the pilot study team. 
 
4.7 Access to data  
The Northern Health and Social Care Trust will be the data controllers and as such will have access to 
the full dataset. Data Processing Agreements will be in place to facilitate the sharing of 
pseudonymised data with specific SHAPES partners for specific purposes. A small anonymous 
dataset will be shared with University College London to enable the further development of the 
MARS and BMQ scales.  

Page 31 of 31 
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under 
grant agreement No 857159 
 
 
Matomo Analytics will be used to track how the participant uses some of the functionalities in the 
SHAPES app and geolocation, this is further detailed in the Data Protection Impact Assessment 
documentation for this pilot. 
 
4.8 Ancillary and post-trial care 
At the end of the pilot the devices provided to participants will be removed and participants will be 
requested to remove the SHAPES app from their phone/tablet. The exception to this may be the 
blood glucose meter as the meter used in this pilot is becoming the standard meter distributed in 
NHSCT. This will be decided on a case by case basis with their diabetes care team.  
 
4.9 Dissemination policy 
Any data that arise from the pilot study will be owned by the Sponsor, NHSCT. On completion of the 
study, all data will be analysed and tabulated and used to prepare a final report, available as one of the 
agreed deliverables of the SHAPES Innovation Action — Deliverable D6.4. This deliverable (and all other 
agreed deliverables) will be available to the public for review and accessible via the SHAPES website 
(www.shapes2020.eu). Participants will be notified of the outcome of the study via a specifically 
designed newsletter. NHSCT will seek to disseminate the findings from this study at conferences and in 
the scientific literature. As per the SHAPES Publication Protocol, all publications arising from this study 
will reflect the range of effort that has made them possible; including conceptualisation of the research 
project and research task, methodology development, data collection and analysis, interpretation and 
discussion of results; as well as project management. Any publications will be read and meaningfully 
contributed to by all named authors. NHSCT will also seek to communicate the findings of this study via 
social media, and in other, non-peer reviewed, media outlets. Participating SHAPES partners will have 
the rights to use data from this study in their own analysis and dissemination plans. As detailed under 
‘Access to Data’, Data Processing Agreements will be in place to facilitate the sharing of pseudonymised 
data with specific SHAPES partners for specific purposes. 
 
5. References 
 
1. Eurostat. Population structure and ageing. Available online: 
https://ec.europa.eu/eurostat/statistics-
explained/index.php?title=Population_structure_and_ageing [last updated June 2021]. 
2. Sustainable development in the European Union: Monitoring Report On Progress Towards The 
SDGs In An EU Context. 2018 edition: Eurostat, European Union, September 2018, p. 63, 
https://ec.europa.eu/eurostat/documents/3217494/9237449/KS-01-18-656-EN-
N.pdf/2b2a096b-3bd6- 4939-8ef3-11cfc14b9329.  
3. Patient empowerment: for better quality, more sustainable health services globally, 
International Alliance of Patients’ Organisations, 2014, http://www.appg-
globalhealth.org.uk/reports/4556656050. 
4. Spargo M, et al. Shaping the Future of Digitally Enabled Health and Care. Pharmacy 2021, 9, 17. 
https://doi.org/10.3390/pharmacy9010017.