NCT05459896 A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress
| NCT ID | NCT05459896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Physiological Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 814 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 814 participants in total. It began in 2024-02-27 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The negative impacts on physical and psychological health brought by COVID-19 seem to perpetuate in the post-pandemic era. It is estimated that there will be an impending mental health crisis in the general population in the aftermath of the pandemic due to the delayed negative impacts of COVID-19 and the associated non-pharmaceutical public health interventions such as social distancing, quarantining, and lockdown. Smart Health, defined as the provision of medical and public healthcare services by using mobile technologies, is a cost-effective and easily operated intervention that can provide various functions and can bring significant changes in people's health behaviour, such as prompting them to adopt a physically active lifestyle. Despite the rapid growth of digital health technology, most of them were developed during pandemic with a focus on delivering non-systematic, general virtual healthcare to people. The aim of this study is 1) to develop a Health Apps for Post-Pandemic Years (HAPPY) driven by the Transactional Model of Stress and Coping Theory, and 2) to evaluate its efficacy of alleviating people's physiological and psychosocial distress during post-pandemic era. A total of 814 eligible participants, both COVID-19 victims and non-COVID-19 victims exhibiting physiological and/or psychosocial distress during post-pandemic era, will be recruited and randomized to either the experimental or the waitlist control group. The experimental group will receive a 24-week intervention combined with an 8-week regular supervision phase plus a 16-week self-help phase. Participants will receive different coping strategies, namely physical training, energy conservation techniques and mindfulness-based coping in the intervention hub at Level 2 based on participants' assessments at Level 1, and enhance self-management at Level 3. Participants' physical activity levels will be measured using commercial wearable sensors. The waitlist control group will receive materials on the promotion of physical and psychological health during waiting period and receive the same intervention as the experimental group in week 25. It is hypothesized that the experimental group will exhibit milder symptoms of physiological and psychosocial distress, and have a more positive appraisal mindset, greater self-efficacy, and more sustainable self-management ability than participants in the waitlist control group.
Eligibility Criteria
Inclusion Criteria: * Aged 18 and older; * Exhibiting physiological and/or psychosocial distress: * A cutoff value of ≥ 20 in the Kessler Psychological Distress Scale (K10) will be used to indicate participants with psychological distress. * A cutoff value of ≥ 4 on the Brief Fatigue Inventory (BFI) indicate participants with physical fatigue; * A cutoff value of \> 5 on the Pittsburgh Sleep Quality Index (PSQI) indicate participants with decreased sleep quality; * A cutoff value of \> 3 on the Numerical Pain Scale (NPS) indicates participants with pain, including headaches, upset stomach, and other forms of pain * Has access to the Internet and a smart phone Exclusion Criteria: * Individuals with any health conditions that could hamper participation in the Health Apps for Post-Pandemic Years (HAPPY), such as severe cognitive, visual, or hearing impairments.
Contact & Investigator
Justina Liu, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT05459896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Physiological Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05459896 currently recruiting?
Yes, NCT05459896 is actively recruiting participants. Contact the research team at justina.liu@polyu.edu.hk for enrollment information.
Where is the NCT05459896 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05459896 clinical trial?
NCT05459896 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Justina Liu, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 814 participants.