Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback

NCT06294210 | Not Yet Recruiting DMC

• 1 other identifier: REC202307012
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

No Disease or Condition is Being Studied; Stress Psychological; Overall Wellness

Keywords

Feasibility study; App co-design; Wearable health monitor

Outcome Measures

Primary Outcomes (1)

• Wellbeing Survey Results

  Students will complete a set of three wellbeing surveys at three month intervals during the study, not including summer break. These surveys include the Perceived Stress Score, Pittsburgh Sleep Quality Index-Adolescent (PSQI-A) assessment, and the EPOCH Measure of Adolescent Well-being.

  Starting at onboarding and measured every three months, assessed up to 70 weeks.

Secondary Outcomes (3)

• Heart Rate Variability Metrics

  Summary metrics will be recorded every five minutes when the student is wearing the device, collected for up to 70 weeks..

• Routine check-ins

  This will be completed three times a week, for up to 70 weeks until the study end date.

• App Engagement

  Every time the student uses the app, assessed for up to 70 weeks until the study end date.

Study Arms (1)

Mobile app and wearable heart rate variability monitoring

EXPERIMENTAL

A mobile app was developed based on students feedback about their wellbeing needs gathered in a previous study through focus groups, surveys and design activities. This app includes features for students to track wellbeing habits, enter goals, access evidence-based resources related to their wellbeing topics of interest, and see heart rate variability summary metrics. These metrics will stream via bluetooth from the wrist-worn wearable device that has been developed at the Royal College of Surgeons in Ireland. This device includes a PPG sensor, charging port, and light indicator. There is no screen, so all data will be displayed through the mobile app.

Device: Mobile app and wrist-worn monitor

Interventions

Mobile app and wrist-worn monitor DEVICE

A mobile app was developed based on students feedback about their wellbeing needs gathered in a previous study through focus groups, surveys and design activities. This app includes features for students to track wellbeing habits, enter goals, access evidence-based resources related to their wellbeing topics of interest, and see heart rate variability summary metrics. These metrics will stream via bluetooth from the wrist-worn wearable device that has been developed at the Royal College of Surgeons in Ireland. This device includes a PPG sensor, charging port, and light indicator. There is no screen, so all data will be displayed through the mobile app.

Mobile app and wearable heart rate variability monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• entering their 5th year in secondary school
• attending one of the three secondary school programmes involved (St. Wolstans, Gorey CS, and the Rush Youth Reach)
• receive consent to participate from a parent/guardian
• in possession of a smart phone

You may not qualify if:

• students did not return parental consent forms

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Related Publications (4)

• Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.

  PMID: 29486547 BACKGROUND

• Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.

  PMID: 25101026 BACKGROUND

• Passmore J, Evans-Krimme R. The Future of Coaching: A Conceptual Framework for the Coaching Sector From Personal Craft to Scientific Process and the Implications for Practice and Research. Front Psychol. 2021 Nov 10;12:715228. doi: 10.3389/fpsyg.2021.715228. eCollection 2021.

  PMID: 34858257 BACKGROUND

• Reeves JJ, Ayers JW, Longhurst CA. Telehealth in the COVID-19 Era: A Balancing Act to Avoid Harm. J Med Internet Res. 2021 Feb 1;23(2):e24785. doi: 10.2196/24785.

  PMID: 33477104 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Justin Michael Laiti, BS Biomedical Engineering

CONTACT

+353 87-408-5833; justinlaiti22@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A group of students will be using the mobile app and wrist-monitor to support their wellbeing while a control group of students will be followed at the same time who will not be using the app or wearable. The survey wellbeing, stress, and sleep scores will be compared between these groups.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: March 11, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02