Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06294210 |
| Other study ID # |
REC202307012 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2024 |
| Est. completion date |
July 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Royal College of Surgeons, Ireland |
| Contact |
Justin Michael Laiti, BS Biomedical Engineering |
| Phone |
+353 87-408-5833 |
| Email |
justinlaiti22[@]rcsi.ie |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the effects of an app and wearable device on the wellbeing of
secondary school students. The app will offer support for stress management, sleep
improvement, and time management. Additionally, it will provide access to educational
resources, text-based coaching, and biofeedback monitoring through the wearable device. The
device, worn around the wrist, will measure heart rate variability as an indicator of stress
response. Throughout the study, students will complete bi-monthly surveys on sleep, stress,
and overall wellbeing. To assess the specific impact of each feature, the app features will
be released incrementally over the course of a year. The intervention group, comprising
students in their last two years of secondary school, will have access to the app and
wearable device, while a control group within the same class will not use the system but will
complete the same wellness surveys. Coaches on this platform will come from the Centre for
Positive Health Sciences MSc in Positive Health Coaching as part of their continued training
in coaching. Coaching will be asynchronous so that students can post questions at any time
during the day, but coaches will respond within 24 hours, during office hours. It will be
made clear that this is not a therapeutic service and will be directed to other resources for
these services. Coaches will file an incident report if a risk arises from a message with
participants. Participants will be given guidelines for the type of questions they can ask
such as asking for advice for setting goals related to their digital habits and sleeping
better. The study's findings will provide valuable insights into the effectiveness of the
app and wearable device in enhancing student wellbeing leading up to their leaving
certification exams.
Description:
App-based wellness resources, coaching support, and biofeedback monitoring for sustained
health and wellbeing of secondary school students
Justin Laiti, Dr. Elaine Byrne, Dr. Pádraic Dunne
Background
Secondary school students across the world face ongoing academic demands that can negatively
impact their mental, physical and social health. Short-term impacts can lead to poor academic
achievement, decreased motivation and increased school dropout, while long-term impacts can
result in mental health issues (anxiety and depression), sleep disturbances, substance abuse
and ultimately, unemployment. The Economic and Social Research Institute (ESRI) conducted a
longitudinal study (2011) of 900 Irish Post-primary school students and found that
exam-related stress was a significant issue, especially related to the Leaving Certificate
exam. Some of this exam-related stress was mitigated by a positive relationship between the
school teachers and the students. While there have been reports of decreasing wellbeing among
secondar school students1, little evidence exists regarding the biopsychosocial impacts of
school-related stress on Irish students. However, the investigators might assume that Irish
students experience similar issues to their international counterparts.
Biofeedback
Biofeedback involves the use of wearable devices that can measure physiological parameters
such as heart rate, pulse, brain waves, heart rate variability (HRV) and skin galvanic
response. Users can monitor these parameters (wirelessly or by direct connection) in
real-time through the wearable device itself or via a smart phone application (app). Users
can monitor how behaviour, as well as external or internal stimuli can impact on these
physiological parameters. In essence, biofeedback can help users to improve behaviours
related to greater health and wellbeing. For example, HRV is widely regarding as an excellent
objective measurement of stress when measured over time (Kim, Cheon, Bai, Lee, & Koo,
2018; Lehrer & Gevirtz, 2014). HRV as a physiological parameter, is a measure of the time
intervals (seconds) between heartbeats, as well as the variability, duration and strength
(measured by power density spectral analysis) of the same interval.
Coaching
An increasing evidence base is emerging from the scientific literature that describes the
positive impact that coaching can have on the overall wellbeing of senior secondary school
students in particular (Dulagil, Green, & Ahern, 2016; Gibbs & Larcus, 2015; Green,
Grant, & Rynsaardt, 2020). Telemedicine (Pearl & Wayling, 2022) and online coaching
(Passmore & Evans-Krimme, 2021) have become more palatable to the public and impactful on
health outcomes since the global COVID-19 pandemic in March 2020. The investigators have
shown from our preliminary research (RCSI Coach Connect) that online coaching for the health
and wellbeing of Irish Healthcare professionals working in the RCSI Hospital Group, can have
positive impacts on wellbeing, overall happiness, positive emotions and burnout
(pre-publication). Online, text-only coaching with accredited coaches, trained in online
communication can provide consenting users with an accessible and economically viable form of
frequent support.
Project aim
This project aims to build and implement an application with text-based coaching, educational
resources, and biofeedback monitoring of fluctuations in HRV for secondary school students.
The investigators are interested to learn if a combined approach whereby students are
supported via online coaching plus continuous biofeedback can have a positive impact on their
health and wellbeing.
Outcomes/objectives
Measure uptake and engagement by secondary school students of the app during the feasibility
study and during the students' final year.
Observe changes in perceived stress as measured by the Perceived Stress Score, Pittsburgh
Sleep Quality Index-Adolescent (PSQI-A) assessment, and the EPOCH Measure of Adolescent
Well-being at 3-month intervals. Perceived stress, sleep quality, and the wellbeing will be
compared between the study cohorts from both schools, compared with representative
counterparts who will not have access to the support platform.
Observe continuous changes in HRV of study participants, as measured by a bespoke,
Bluetooth-enabled wearable device.
Observe correlations between HRV and routine check-ins delivered three times a week through
the app which will include mood, stress level, and drowsiness
Conduct a qualitative assessment (6-month intervals) of representative users regarding
platform engagement, and the coaching process, as well as needs related to health and
wellbeing.
Deliverables
Report on psychological, social and physical health baselines of on-boarded participants
Three-monthly reports on perceived stress (Perceived Stress Scale), Pittsburgh Sleep Quality
Index-Adolescent, and EPOCH Measure of Adolescent Well-being
Six-monthly reports on quality improvement cycles to inform better functioning, uptake and
engagement
Summary analysis report for students, educators, and policy makers
Summary aggregate data report for public consumption on appropriate FAIR platforms
Project Timeline
Needs Assessment Survey
In the first phase of this project (February 2023), a needs assessment survey was sent to the
students, teachers, and parents at the schools involved in this study. The purpose of this
survey was to gather information about the wellbeing needs of these groups so that the
investigators can tailor the rest of the project towards. This survey was sent during
students' transition year (TY) and the data recorded was anonymous. It asked questions
related to sleep, stress management, social connections, and the use of apps and wearables to
support student wellbeing.
Co-design
In the second phase of this project (April-November 2023), co-design sessions were run with
TY students at each school to facilitate discussions and workshop activities about
students' wellbeing needs and their opinions about the design and features of the
wearable device and mobile app that will be used in this project. These sessions were
completed over the course of four weeks in four, one-hour-long sessions. The anonymous notes
and feedback from students were compiled from this phase to inform the development of the
following phase.
Wearable System Feasibility Test
In the third phase of this project (March 2024 - May 2024), students will test the
functionality of the app and wearable. They will initially onboard onto the app in March when
they will also give feedback on the personalised features for their wearable including the
case and strap colour and an inscription on the face of the case. Students will then receive
their wearable during the first week of April. They will use the app and wearable until the
end of the school year, completing routine check-ins and taking their HRV baseline at the
start and end of the study. In the final week of the study, students will complete
outboarding surveys and a small group at each school will participate in focus group
feedback.
Wearable System Implementation Pilot Study
In the fourth phase of this project (September 2024 - May 2025), students will use the app
and wearable throughout their final year at school. At this point they will be given access
to a wearable heart rate variability monitor and a mobile application which will connect them
with online coaching, educational resources, and information streamed from the wearable.
Students will be able to use this system to support them throughout their 6th year leading up
to their leaving certification exams. The following project description outlines the
components of this fourth stage.
Study design, approach and methodology
Study design: The investigators will use a participatory mixed method design (Cresswell et
al, 2011), incorporating a prospective cohort study design and qualitative research
assessment with participation of the teachers and students involved in the study. The
prospective cohort study will have two study groups based at two schools. The human coach-led
chat, messaging smart phone application system, will allow accredited coaches to support
secondary school student cohorts (44 students in each cohort) based at two Irish secondary
schools between transition year (year 4) and the final two years of secondary school (years 5
and 6), culminating in the Leaving Certificate examination. The investigators also propose to
support guidance counsellors and the year head teachers (based at the same schools) over the
same period, since teachers are also exposed to significant stress (Scheuch, Haufe, &
Seibt, 2015). There will be assessment of bio-psycho-social parameters, including continuous
HRV measurements, perceived stress, and wellbeing between baseline and 6-monthly assessments
up to 30 months. Coaches on this platform will come from the Centre for positive Psychology
and Health MSc in Positive Health Coaching as part of their continued training in coaching.
Each coach will be supervised by a fully accredited Master Coach, provided by the Centre.
Oversite of the coaching process will be managed by the PI (Pádraic Dunne) and Prof Christian
Von Nieuwerburgh (co-director of the MSc in Positive Health coaching and international
coaching expert).
Platform Development An android and apple compliant smartphone app will be created that
allows participants to communicate with coaches via text messages. Coaches will use the
application to share resources while communicating with participants. The app will also
display HRV data for each participant and their respective coach. A collaborative and
interactive programme (Figma) will be used to create wireframes for the app with the required
functions. These wireframes generate clickable mock-ups of the app flow, layout and graphic
design. Students and teachers will have the opportunity to create their own designs or give
feedback on already existing designs for the app. Once the layout is confirmed, all
information will be coded to develop a functional smartphone app. Swift and Android Studio
will be used to code for apps that will be functional on Apple iOS and Android devices,
respectively. Once the app is developed, the user interface and functionality will be tested
with the teachers and students involved in the study. This will ensure the functionality of
the app in terms of being able to (1) connect participants to coaches, (2) stream user HRV
data, (3) provide a seamless interface between user and the system and ensure data security.
Wearable Device Development A relatively low-cost, wearable device (estimated cost per
assembled unit is €70) will be assembled that measures HRV. The device will likely fit around
the wrist and be enclosed in a skin compatible casing. The device will include a power
button, a light indicator, and a charging/data transfer port. Components within the device
will include a small circuit, a processing board, an SD card, and a power supply. Either a
light emitting diode or an electrode will be placed along the bottom of the device to be in
contact with the skin and measure heart rate using either photoplethysmography (PPG) or
electroencephalography (EEG). Both methods are non-invasive and commonly used to measure
heart rate and HRV. This will be a co-design process, so the students and teachers involved
in the study will assist with the design and assembly decisions throughout the construction
of the device. Once the device is assembled, it will go through a series of testing
procedures before being included in the study. The investigators will verify the accuracy of
the HRV sensor by comparing it to two commercial heart rate sensors (Inner Balance device
developed by HeartMath; Muse 2 device developed by Muse Inc.) owned by the Centre for
Positive Psychology and Health. The investigators will collect data on both devices
simultaneously to ensure that there is not a significant difference in the variation data
being captured by the devices. A risk matrix will also be created to identify any aspects of
the device that could cause harm to the participants. Adjustments will be made to the device
to ensure minimal risk to the participants. Once the device is tested and any risks to
participants are minimal, the investigators will order the additional supplies necessary to
construct all of the sensors and develop a standard testing technique to ensure the accuracy
and safety of each one. The components for the device will be purchased from Digi-key
Electronics and Amazon.co.uk. Individual devices will subsequently be co-assembled with
students at each school.
Digital support repository
Secure video content on health and wellbeing, created by RCSI, HSE, Healthy Ireland,
Sláintecare will be accessible in the form of secure uniform resource locator (url) addresses
from government websites or secure RCSI Vimeo and YouTube accounts. Content will include a
complete 8-week Attention-based Training (ABT) programme for health and the online RCSI
Science of Happiness for Young People (8 and 10 week courses, respectively) provided by the
RCSI Centre for Positive Psychology and Health.
Data security A Data protection impact assessment (DPIA) will be completed to mitigate risks
associated with data security. The data from both the wearable device and the messaging
platform will be secured within the device itself and on an external drive. The wearable
device data will be stored on an SD card until uploading to the password protected, mobile
application via Bluetooth. The data will be available to the participant and the coach
through this application and will be uploaded to an RCSI One Drive account which the research
team will have access to. In addition to authentication required to use the application, data
will be encrypted as it is transferred from the wearable device to the application and then
from the application to the One Drive account. The investigators will obtain an SSL/TLS
Certificate to securely transfer data using HTTP as well as encrypt the data while it is
stored. The application will also be able to be updated to that security vulnerabilities can
be addressed during the testing phase. The data from the wearable device will include HRV
values and timestamps which will be uploaded to the app via Bluetooth. Application data
(messages and HRV values) will be kept on the app for 30 days. This project will be conducted
in line with current GDPR guidelines: the lawful basis of processing of personal health data
is based on Legitimate Interests, under Article 6(1)(f), and Consent, Article 6(1)(a). All
data collected will be reviewed and determined to be of high necessity and commensurate in
proportionality. Data collected will be determined to be the lowest needed data processing to
achieve the desired outcome. The data processing will be purpose built to help individuals
most effectively monitor and improve their wellbeing. To prevent function creep, all data
collected and processed will be reviewed by the PI and approved by the data controllers (PI
Dr Pádraic Dunne and PhD Scholar Justin Laiti). For all data, nothing more than what is
needed will be collected, and the scope of the processing activity will be held only to its
defined purpose(s). The data controller and PI will ensure that privacy policies are built
with the purpose of guaranteeing limitation and data minimisation. At consent, individuals
(and their legal guardians) will be provided with the data collected and purpose of the data.
If changes occur, and are approved by the data controller, individuals will be notified of
the specific change(s). An updated consent form will be generated. All researchers must
document, demonstrate, and provide proof that they meet GDPR requirements for data
protection/security, privacy, and processing. Data will be hosted, stored, and backed-up in a
virtual private cloud (RCSI) physically located in the EU (Dublin).
Recruitment and participants. Forty-four secondary school students (beginning in transition
year and culminating in final year of school) will be recruited from Athy College Post
Primary DEIS School in Co. Kildare. Twenty secondary school students (beginning in transition
year and culminating in final year of school) will be recruited from Cross and Passion
secondary School in Kilcullen, Co. Kildare. Two year-head teachers and two guidance
counsellors will be recruited from each school. Twenty representative control students (5th
year and 6th year students) and six general schoolteachers, who will not have access to the
platform, will be recruited from the same schools. The Centre for Positive Psychology and
Health has run the RCSI Winter School at Athy College since 2020 and therefore has a good
relationship with teachers and students at the school. The investigators have learned that an
online information morning provided by RCSI researchers, and facilitated by head teachers and
guidance counsellors with transition year students present, is the best way to provide
information on the study and to answer any questions. The investigators will adopt the same
approach both schools. The investigators will also hold an information evening for students
and their guardians who may have questions about the project. Students, teachers and
guardians/parents will receive hard copies of participant information leaflets (PIL) and
consent forms. There will be an option for students who reach the age of 18 years during the
life of the project to complete and sign a replacement consent form. The school guidance
counsellor for each school will act as the gatekeeper for communication between students,
their guardians and RCSI researchers.
Recruitment of control participants and the Principle of Equipoise
Although the investigators hypothesise that online text-based coaching will prove beneficial
for the health and wellbeing of users (students and teachers), the benefits remain uncertain.
At the end of the project and providing the coach-led platform is beneficial to wellbeing,
the investigators will consult with teachers and students how the investigators might scale
this offering to the remaining students and teachers at each school (resources permitting).
Garda vetting for RCSI researchers
The schools will facilitate the completion and processing of GARDA vetting forms for
researchers in contact with students (virtually or in the classroom), as with previous
iterations of the RCSI Winter School. Researchers will never be alone with any student;
either the school guidance counsellor or year-head will be present in the classroom for
in-person sessions.
Digital support platform on-boarding process
On-boarding will occur through smart phone applications, whereby consenting participants
will:
Receive a unique study code identifier and chose avatar name from a provided list of male and
female first names. The code is made up by answering the following questions:
Q1 Please type in the first letter of your mother's first name (e.g. Maria: M)
Q2 Please type in the first letter of your father's first name (e.g. Andrew: A)
Q3 Please type in the your house number (e.g. Number 42 = 42); if the participants don't have
a house number, type "oo"
Q4 Please type in the first letter of your place of birth (e.g. London: L)
Q5 Please tick the box that contains the last number of your year of birth (e.g. if the
participants were born in 2009 = 9): 0=12; 1=23; 2=24; 3=25; 4=26; 5=27; 6=28; 7=29; 8=30;
9=31.
A full example might look like this: BP16D25
Identify preferred communication style and readiness to change level
Identify personal goals relating to sleep, eating well, physical activity, alcohol, tobacco
and other substance use, relationships and stress management
Complete paper surveys in the classroom at six-month intervals assessing wellbeing and
perceived stress
Introduced to their coach via text through the bespoke project smartphone app
Questionnaires and assessments
The investigators will ask participants to complete two questionnaires in paper format in the
classroom setting that are designed to measure current state of health and wellbeing and
perceived stress. Perceived Stress score and the EPOCH measure of wellbeing. In his 2011 book
Flourish, Dr. Martin Seligman, founder of the field of positive psychology, defined 5 pillars
of wellbeing, PERMA (positive emotion, engagement, relationships, meaning, accomplishment).
Seligman and colleagues adjusted the model to be developmentally appropriate for adolescents
and referred to it as the EPOCH measure of wellbeing. The resulting model consists of five
different positive characteristics that together support higher levels of well-being:
engagement, perseverance, optimism, connectedness, and happiness (EPOCH). This is instrument
has been validated in a number of different international research projects1.
Quality improvement study. The investigators will use the IHI Model for Improvement (MFI)
developed by Langley et al (1992) to create and model changes, test proposed changes, measure
the results and then accept or modify the proposed changes. The MFI promotes rapid testing
for rapid learning and each phase of QI will be fed back into the design and implementation
of the coaching intervention. The approach involves three questions and a fourth section
which is a tool for testing changes. The questions are: What are the investigators trying to
accomplish? How will I know if a change leads to an improvement? What changes could the
investigators make that will result in improvement? With the fourth section of Plan, Do,
Study, Act (PDSA) allowing for rapid cycles of changes, measurement and learning. At the
outset tools such as process maps, Pareto charts, Ishikawa (fish-bone) diagrams, and key
driver diagrams will assist in the structuring and visual representation of the processes and
setting. Besides the quantitative measures outlined above that will be included at all phases
of the process semi-structured interviews (with teachers n=4) and Focus Group Discussions
(n=2 with 7-8 students) will be conducted before and after each cycle. Students (in the form
of focus group discussions) and teachers (semi-structured one-to-one interviews with
researchers) will be interviewed for a maximum of 40 minutes after quality improvement cycles
on each school campus. Researchers will not be permitted to interview students under 18
years, alone; a teacher will be present at all times. These interviews will be recorded by
researchers using digital recorders. Once transcribed, all audio files will be permanently
deleted. Transcripts will be stored in a secure location on RCSI main campus for a maximum of
12 months. Interviews will be assessed using NVivo software and thematic analysis. A
participatory design approach will underpin our study design- from conceptualisation,
implementation and improvement. Participant involvement is research 'with' or 'by' members of
the public rather than 'to', 'about' or 'for' them (INVOLVE, 2016)2. Teachers and students
will initially be recruited to assist in the design of the programme as well as the
technological support, such as type of material that they potentially would find useful,
timing of activities, type of wearable device and app they would find appealing etc.
Thematic Analysis. Thematic analysis will be used to analyse all qualitative data. Thematic
analysis is a theoretically flexible approach that allows the combination of inductive and
deductive methods. This facilitates participatory research, where participants are seen as
collaborators, and produces analysis that is accessible and can inform policy development.
During the co-design stage of the project, analysis will focus on identifying themes that
relate to the needs and experiences of students and teachers. In the evaluation stage,
analysis will explore whether the online coaching support platform can help cultivate and
sustain mental health and wellbeing among participants and any barriers to engagement.
Thematic analysis will also allow researchers to focus on identifying patterns related to
participants lived experience of using the digital health platform.
Risks mitigation related to data management
Risk 1 - User data is collected that isn't listed in the consent: a full review of
consent, before each new release will be conducted to ensure that all data collected is
included in the consent agreement. Existing users with receive a new consent with a
description of the additional items added.
Risk 2 - User is added as a user in the application prior to initial consent: users will have
a clear process that is adhered to for gaining consent prior to adding new users to the
application.
Risk 3 - In cases of unauthorised exposure of data. To prevent data breach, the following
aspects will be built into the online platform and data capture system: encryption keys;
anonymised database; two-factor authentication; Host Intrusion Detection System (HIDS)
Intrusion detection; malware protection; active system monitoring; distributed
denial-of-service (DDoS) protection; a deny-all firewall; hypervisor detection; network &
host vulnerability scanning; logical and physical segregation; test data security systems;
implementation of Auth0 software; implementation of GDPR training for all researchers. In the
case of a data breach, we will inform the user and their legal guardian of this breach and
subsequently conduct a comprehensive policy & procedure review and implement remediation.
Text coaching risk - "What if something goes wrong when I'm taking part in this study?"
It is important to note that this coaching platform is not designed to take the place of
psychotherapy and is not a therapeutic service. However, the psychological health of
participants will be monitored by the system and assigned coach using the two survey
instruments described in the methods (EPOCH wellbeing measure and Perceived Stress Score).
High or low scores (reported by the bespoke system in terms of heart rate variability or via
survey results) will be reported to the participant and their legal guardian by the PI (Dr
Padraic Dunne), using their pre-defined preferred communication method. Users (as well as
their legal guardians in the case of those under 18 years) will be advised to contact their
personal GP and psychotherapeutic support. Coaches will complete an incident report for the
Principal Investigator (Dr Padraic Dunne) who is a qualified, accredited psychotherapist.
Physical metrics measured throughout the study will involve those related to heart rate
variability (HRV) as an objective measure of stress. Participants (as well as their legal
guardians in the case of those under 18 years) experiencing HRV measurements that are
indicative of ongoing stress will be asked to contact their personal GP and/or psychology
support. An incident report will be made to the Principal Investigator (Dr Padraic Dunne).
Individuals who are in need of psychological support are referred to the list of supports
provided by the Health Service Executive of Ireland (HSE)
(https://www2.hse.ie/services/mental-health-supports-and-services-during-coronavirus/). This
list includes contact details for Turn2Me, Shine, MyMind, Suicide-Or-Survive, Samaritans,
PIETA house, Stress Control, Clanwilliam Institute, Helplink Mental Help, Aware, and Alone.
Note - the RCSI sponsorship officer (Maurice Dowling) will be informed of this study and will
receive a complete clinical trial registration form.
Statistical analysis
Descriptive statistics and longitudinal modelling of outcomes will employed throughout; the
RCSI Data Science centre have and will advise the research group on appropriate application
of relevant statistics during the project. Based on this advice, the investigators will
analyse the data as follows: Internal consistency of the validated instruments will be
measured using Cronbach's alpha test. Single imputation will be used to replace missing
values. Mean and standard deviation values will be denoted as follows: (x= x[y]). Paired and
unpaired t-tests (denoted as P values) will be used to examine intra- and inter-group
differences. One- and two-way mixed analyses of variance will be used to compare multiple
datasets with independent variables of group and time. Linear regression analysis will be
used to examine changes in either group over time. Cohen's d and associated effect size
calculations (U3) will be applied to mean and standard deviation results. Probability of
superiority will be subsequently calculated using effect size values. Cluster analysis will
be conducted on both schools as advised by the RCSI Centre for Data Management who have been
consulted about this project. Qualitative interviews will be thematically analysed
iteratively to inform quality improvements. TRE-AIM framework as an evaluative tool
six-monthly quality improvement cycles focused on RE-AIM headings: Reach (uptake),
Effectiveness (trajectories of distress), Adoption (applicability to other cohorts in
future), Implementation (accounting for adaptations/changes, barriers), Maintenance. Other
quality improvement tools such as fishbone analysis, SWOT analysis, and stakeholder maps will
also be employed. Power calculations will be determined at the end of year one when changes
in wellbeing and perceived stress will be compared between controls and intervention group
students and teachers.
