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The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard-based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that (i) harness the next generation of healthcare and wellness innovations; (ii) cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities; (iii) straightforwardly fit "by design" with European regulations, on data protection, consumer protection and patient protection (iv) are subjected to trustable certification processes; (iv) support value generation through the deployment of advanced business models based on the VBHC paradigm.
GATEKEEPER will demonstrate its value by scaling up, during a 42-month work plan, towards the deployment of solutions that will involve ca 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states. Recently 3 Asian pilots have been added as a result of the Open Calls.
The achievement of the overall objective is supported by the following, among others, specific objective: To execute a series of PILOTS to demonstrate the effect, benefit, value and scalability of the GATEKEEPER solutions around REFERENCE USE CASES COVERING PRIMARY, SECONDARY and TERTIARY PREVENTION, initially deployed in 8 regions of 7 European countries.
The Cyprus pilot mainly focuses on the early detection of the condition worsening of cancer and dementia patients by monitoring whether the use of technology can trigger appropriate management, thereby reducing the need for higher acuity care, and even, at times, improving survival by supporting demand-driven solutions through high-quality health mobile systems.
Full description
Primary Outcome The Primary Objective of the proposed pilot will be the improved Health-Related Quality of Life (HRQoL) for patients participating in the full intervention and limited intervention groups compared to patients in the control group.
It is hypothesized that the improvement will he higher for the full intervention group patients compared to the limited intervention group patients.
Secondary Objectives
The secondary outcomes are measured as follows:
Materials
Hardware
Questionnaires
There will be three evaluation periods (baseline, intermediate and final) during the two-year pilot and the evaluation tools used are the following:
Self-report at home (PASYKAF) or at inpatient and outpatient clinic (AMEN) through GATEKEEPER using tablets
Patients:
For PASYKAF
For AMEN
Caregivers:
For AMEN and PASYKAF
Healthcare Professionals:
For AMEN and PASYKAF
Research Design This is a pilot randomized controlled trial (RCT) with between and within subject design
Randomization Stratified random sampling creating subgroups based on gender, age range, and stage of illness (for both organizations). We will use the ECOG scale (13) to assess cancer patients' stage. We will use a randomization at the patient 1:1 level. Nurse assistants, social workers, physiotherapists and psychologists cannot be employed in both sites at a time and patients are unlikely to move from a control to an intervention facility, due to the geographical spread of facilities and the fact that they treat different conditions (cancer at PASYKAF and dementia at AMEN). We will also audit the recruitment rates across arms to investigate the extent of any differential recruitment and if any bias might accrue. The sites will be visited by the Field Coordinator and other research staff to present the project and its needs; a consultant statistician will then produce the random allocation of patients for either the intervention or the control arm of the study.
Blinding procedures The Research Assistants, nurses, social workers, physiotherapists and psychologists responsible for data collection will not have access to the information of which group (control or intervention) the participant is.
Study Population The users involved in the pilot are cancer patients (+50) and dementia patients (+65) that face comorbidities, professional caregivers or relatives that have the role of the informal caregivers and health care professionals of the participating organizations.
In more detail:
i. Patients with mild, moderate, and severe dementia aged 60+ and high complexity level cancer patients, aged 50+, will participate in the study. People with dementia will be recruited by the "Archangelos Michael" nursing home (AMEN) and people with cancer will be recruited by the Cyprus Association of Cancer Patients and Friends (PASYKAF).
ii. Healthcare professionals from both organisations will participate in the study. This includes professions of psychologists, social workers, speech therapists, nursing staff, physiotherapists, gymnasts and art therapists (e.g., music therapists, paint therapist, theatre therapist).
iii. Two hundred and fifty cancer patients' caregivers (n=250) and one hundred and forty-five dementia patients' caregivers (n= 145) will also participate in the study.
Procedure
The intervention will be delivered at a community level as following:
The patients of both organisations will be screened to fulfil the inclusion criteria (i.e., face difficulties with co-morbidities). Then, participants (also including informal caregivers) in the intervention group will be provided with a health-promotion application based on software and hardware (commercial devices) solutions for supporting and managing users.
The Control Group will receive current standard of care for any of their ongoing health conditions. In addition to this, and following randomization, their symptomatology and quality of life will also be assessed, at least three times (in the participant's baseline assessment, and follow-ups). In each of these encounters, there are established procedures to implement appropriate action if further mental health support is needed.
Sample Size Calculation
This is a pilot RCT (14) so according to standard procedures a formal power calculation is not required and sample was determined by the research team based on experience. However, we have performed sample power calculation for patients participating in the trial as followed:
We estimated that with 251 patients, the study would have 80% power to detect a significant between-group difference in the change in the HRQOL score from baseline to 6 weeks, with a medium effect size of 0.5 SD. We allowed for the enrollment of an additional 20% of participants in order to compensate for the loss of any patients to follow-up which provides a targeted sample size of 300 patients.
Assignment to study groups The Control group will receive standard health care with no technical support, where the intervention groups will receive platform and device services provided to each user. In that respect, Intervention Group 1 will receive no real-time feedback, where Intervention Group 2 will unhand with real data and notifications.
Control Group - standard healthcare (no technology group) A control group is defined as a group of clinical trial participants who will not be provided any digital devices as part of the trial and will receive care as usual by PASYKAF and AMEN.
Intervention Group 1 - platform/devices (no real feedback provided (limited technology group) A limited technology group is defined as a group of clinical trial participants who receive the digital devices but not the automated interventions through the devices (prompts, messages).
Intervention Group 2 -platform/devices (with real feedback provided) (full technology group) A full technology group is defined as a group of clinical trial participants who receive the digital devices as part of the trial and healthcare professionals receive the patients' data.
Asessment Timeline Screening (e.g., ECOG etc.) for eligibility Baseline assessment (all questionnaires will be completed and patients and caregivers in intervention groups will receive the devices).
During the intervention (6 weeks) (self-report and physiological parameters assessment using the wearable devices and the app Follow up at 6 weeks (all questionnaires will be completed and in addition patients, caregivers and healthcare professionals in intervention groups will complete questionnaires related to usability, feasibility and acceptability of technology).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria (cancer patients):
Exclusion criteria (cancer patients):
Inclusion criteria (cancer patients' caregivers):
Exclusion criteria (cancer patients caregivers):
Inclusion criteria (healthcare professionals)
Primary purpose
Allocation
Interventional model
Masking
300 participants in 3 patient groups
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Central trial contact
Angelos P. Kassianos, PhD
Data sourced from clinicaltrials.gov
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