Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05490524 |
| Other study ID # |
CUT_DN_01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
March 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Cyprus University of Technology |
| Contact |
Angelos P. Kassianos, PhD |
| Phone |
0035725002252 |
| Email |
angelos.kassianos[@]cut.ac.cy |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
