Trial Title:
Smart Living Homes: GATEKEEPER System With Patients With Cancer and Dementia in Cyprus
NCT ID:
NCT05490524
Condition:
Neoplasms
Cancer
Dementia
Conditions: Official terms:
Dementia
Conditions: Keywords:
cancer
digital health
dementia
eHealth
RCT
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
group)
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The patients, 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.
Intervention:
Intervention type:
Device
Intervention name:
GATEKEEPER
Description:
The GATEKEEPER is a digital platform that allows patients and caregivers to record their
day-to-day symptoms and other parameters such as quality of life using means such as apps
and wearable devices that record both self-report (quality of life, depression, anxiety)
and physiological data (mobility, pain, sleep patterns, heart rate), and allows
healthcare professionals to monitor these data and tailor healthcare so to prevent and
intervene in symptoms that may be occurring.
Arm group label:
Intervention group 1 (limited technology)
Arm group label:
Intervention group 2 (full technology)
Summary:
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.
Detailed 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:
1. Secondary Objective for patients: includes improved parameters of patients
participating in the full and limited intervention groups associated with the
improvement in disease self-management; symptom burden; motivation; mobility; sleep
hygiene; depression and anxiety.
2. Secondary Objective for caregivers: includes improved parameters of caregivers
participating in the full and limited intervention groups associated with caregiver
burden; depression and anxiety.
3. Secondary Objective for healthcare professionals: includes improved parameters of
healthcare professionals before and after introducing technology associated with
anxiety and technology acceptance.
4. Secondary Objective for technology evaluation: includes the feasibility, usability
and acceptability of the technology used by patients, caregivers and healthcare
professionals.
Materials
Hardware
- Activity Tracker - Garmin Venu Sq. 37mm is a wearable watch suitable for Health
Monitoring (i.e. wrist-based heart rate, daily resting heart rate, abnormal heart
rate alerts, all-day stress, relaxation reminders, relaxation breathing timer,
sleep)
- Tablet - LENOVO Tab M10 10.1'' 64GB
- Tablet - LENOVO Tab M10 4G LTE 10.1'' 32GB
- Mobile XIAOMI Redmi 9C
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
- Socio-demographics information including age, gender, educational level, marital
status, type of diagnosis etc.
- EORTC QLQ C-30 (1) is a cancer health-related quality-of-life questionnaire that has
been widely validated and used in clinical trials and investigations using PROs for
individual patient management. It is composed of both multi-item scales and
single-item measures. The QLQ-C30 will be administered at admission and at 6 weeks.
- IPOS (2) is a measure of global symptom burden which includes items that measure
physical, psychosocial, social and spiritual domains in line with an impeccable
holistic assessment. It allows patients to list their main concerns, to add other
symptoms they are experiencing, and to state whether they have unmet information or
practical needs. It can assess and monitor symptoms and concerns in advanced
illness, determine the impact of healthcare interventions, and demonstrate quality
of care. The IPOS will be administered at admission and at 6 weeks.
- HADS (3) is a self-report scale developed to assess psychological distress in
non-psychiatric patients in both hospital and community settings. It consists of two
subscales, measuring symptoms of depression (HADS-D), and anxiety (HADS-A).
Following completion of the HADS, a pop-up section will follow that allows use cases
to provide any additional information that they may feel is important regarding
their psychological well-being - qualitative data/ free word to describe their
personal lived experience (completion is optional). HADS will be administered at
admission and at 6 weeks.
- System Usability Scale (SUS) (4) (simplified version) will assess the usability of
the platform and the devices on a 5-point Likert scale (1 = strongly disagree and 5
= strongly agree). SUS will be administered at 6 weeks.
- The Single Ease Question (SEQ) will assess the level of difficulty for each
interaction on a 7-point Likert scale (1 = very difficult and 7 = very easy). SEQ
will be administered at 6 weeks.
For AMEN
- EQ-5D (5) is a standardised measure of health status to provide a simple, generic
measure of health for clinical and economical appraisal. The EQ-5D provides a simple
descriptive profile and a single summary index value for health status. The EQ-5D
will be administered at admission and at 6 weeks.
- MOCA (Montreal Cognitive Assessment Greek Version) assess the cognitive decline of
the person based on tasks related to attention and concentration, executive
functions, memory, language, visuoconstructional skills, conceptual thinking,
calculations, and orientation. The MOCA will be administered at admission and at 6
weeks.
- Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the
elderly; it includes tests of orientation, attention, memory, language and
visual-spatial skills. The MMSE will be administered at admission and at 6 weeks.
- Geriatric Depression Scale (GDS) (6) will be used to measure depression and is often
used to assess depression in the elderly patients. The app will utilize simple, easy
to respond, and user-friendly statements or questions that can be answered by the
patient or/and the main caregiver.
- Geriatric Anxiety Scale (GAS) (7) will be used to measure anxiety and is often used
to assess depression in the elderly patients. The app will utilize simple, easy to
respond, and user-friendly statements or questions that can be answered by the
patient or/and the main caregiver.
- System Usability Scale (SUS). A simplified version of the SUS will assess the
usability of the platform and the devices on a 5-point Likert scale (1 = strongly
disagree and 5 = strongly agree). SUS will be administered at 6 weeks.
- The Single Ease Question (SEQ). SEQ will assess the level of difficulty for each
interaction on a 7-point Likert scale (1 = very difficult and 7 = very easy). SEQ
will be administered at 6 weeks.
Caregivers:
For AMEN and PASYKAF
- Zarit Burden Interview (8) is a self-report questionnaire assesses caregiver
perceptions of burden that may inadvertently affect their health, personal, social
or financial wellbeing.
- System Usability Scale (SUS) will assess the usability of the platform and the
devices on a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree).
- The Single Ease Question (SEQ) will assess the level of difficulty for each
interaction on a 7-point Likert scale (1 = very difficult and 7 = very easy).
- Beck Depression Inventory (BDI) (9) is a standardized measure to assess symptoms of
depression in the general population.
- State Trait Anxiety Inventory (STAI) (10) is a standardized measure to assess
anxiety in the general population.
Healthcare Professionals:
For AMEN and PASYKAF
- A modified version of the Unified Theory of Acceptance and Use of Technology (UTAUT)
(11,12) tool will be used to assess whether healthcare professionals accept the use
of GATEKEEPER and other technologies during the study.
- System Usability Scale (SUS) will assess the usability of the platform and the
devices on a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree).
- The Single Ease Question (SEQ) will assess the level of difficulty for each
interaction on a 7-point Likert scale (1 = very difficult and 7 = very easy).
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).
Criteria for eligibility:
Criteria:
Inclusion criteria (cancer patients):
- Aged: Over the age of 50 years
- Adequate understanding of Greek and/or English Language
- Cancer diagnosis/ ICD-10: Illness classification system
- Functional status/ ECOG Performance Status 0,1,2,3
- ECOG Performance Status 4 only if Phase of Illness and Prognosis permits
- Phase of illness (Based on Medical Assessment and presenting prognosis/ the Patient
is expected by the Health Care Team to be able to complete the 6-week study period)
- Patient receiving Health Care Services from PASYKAF
Exclusion criteria (cancer patients):
- Aged < 50 years
- Psychiatric diagnosis
Inclusion criteria (cancer patients' caregivers):
- Over the age of 18 years
- Adequate understanding of Greek and/or English Language
- Primary caregiver of patient with cancer
- Patient/ Caregiver receiving Health Care Services from PASYKAF (The primary
caregiver is a family member or friend that supports a patient through cancer
treatment, helps with daily activities, such as going to the doctor or preparing
meals, coordinates services and care and provides emotional and spiritual support,
www.cancer.gov)
Exclusion criteria (cancer patients caregivers):
- Aged < 18 years
- Not able to consent
Inclusion criteria (healthcare professionals)
- PASYKAF employed Health Care Professionals( Nurses, Psychologists, Social Workers
and Physiotherapists) that provide services in all districts of Cyprus (Nicosia,
Limassol, Larnaca, Paralimni, Pafos)
- Adequate understanding of Greek and/or English Language
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cyprus University of Technology
Address:
City:
Limassol
Zip:
3036
Country:
Cyprus
Status:
Recruiting
Contact:
Last name:
Angelos P. Kassianos, PhD
Phone:
0035725002252
Email:
angelos.kassianos@cut.ac.cy
Start date:
June 1, 2021
Completion date:
March 2023
Lead sponsor:
Agency:
Cyprus University of Technology
Agency class:
Other
Collaborator:
Agency:
Pancyprian Federation of Cancer Patients and Friends
Agency class:
Other
Source:
Cyprus University of Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490524
