Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05459896
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2022-07-11
Brief Title:
A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
A Health Apps for Post-Pandemic Years HAPPY for People With Physiological and Psychosocial Distress During the Post-Pandemic Era
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 peoples 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 peoples 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 andor 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
Detailed Description:
Studies indicate that during the pandemic people particularly those COVID-19 survivors are more likely to experience distress symptoms including physical fatigue decreased sleep quality and body pain than during normal times The abovementioned impacts on health can affect everyone during the COVID-19 pandemic These negative impacts on physical and psychological health also 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 Studies showed that around 10-30 of people who have contracted COVID-19 present with post-COVID-19 conditions or Long COVID and among all the symptoms physical and psychological complications such as depression anxiety and reduced quality of life are commonly reported This indicates an urgent need to identify an evidence-based intervention to address the health issues of people whose health has been affected by COVID-19
Smart Health is defined as the provision of medical and public healthcare services by using mobile technologies such as mobile phones tablet devices personal digital assistants PDAs and other wireless devices A smart health intervention is a cost-effective and easily operated intervention that can provide various functions including self-monitoring data collection real-time feedback and notifications Appropriate use of smart health-based interventions can bring significant changes in peoples health behaviour such as prompting them to adopt a physically active lifestyle In a systematic review of 12 studies with a total of 3469 participants in which the effects of mobile app-based interventions were compared with those of the usual care significant effects on health outcomes were found from using mobile apps to manage chronic diseases such as improved physical functioning and increased medication adherence
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 This research gap gives us the impetus to develop a 24-week intervention guided by an innovative three-level Prevention Protection and Progression Health Apps for Post-Pandemic Years here-and-after as HAPPY driven by the Transactional Model of Stress and Coping Theory TMSCT to address COVID-related physical and psychosocial distress symptoms of people during the post-pandemic era The TMSCT emphasizes the use of appraisals to evaluate the harm threats and challenges that result in the process of coping with stressful events The level of stress experienced in the form of thoughts emotions and behaviours as a result of external stressors depends on appraisals of the situation which involves a judgement about whether the internal or external demands exceed an individuals resources and ability to cope when the demands exceed the resources Positive emotions will be elicited when individuals are capable of resolving stressors with the utilisation of both internal eg cognitive appraisals emotion regulation and external resources eg social support access to new knowledge and skills while negative emotions will be elicited as a result of unresolved distress
This protocol aims to evaluate the immediate effects eight weeks after weekly supervised sessions ie on the 8th week and the mid-term effects six months when the intervention has been completed ie on the 24th week of the HAPPY for alleviating peoples physiological and psychosocial distress during the post-pandemic era It is hypothesised that the experimental group will 1 exhibit greater improvement in physiological and psychosocial distress and 2 have a more positive appraisal mindset greater self-efficacy and more sustainable self-management ability than participants in the waitlist control group
Smart Health is defined as the provision of medical and public healthcare services by using mobile technologies such as mobile phones tablet devices personal digital assistants PDAs and other wireless devices A smart health intervention is a cost-effective and easily operated intervention that can provide various functions including self-monitoring data collection real-time feedback and notifications Appropriate use of smart health-based interventions can bring significant changes in peoples health behaviour such as prompting them to adopt a physically active lifestyle In a systematic review of 12 studies with a total of 3469 participants in which the effects of mobile app-based interventions were compared with those of the usual care significant effects on health outcomes were found from using mobile apps to manage chronic diseases such as improved physical functioning and increased medication adherence
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 This research gap gives us the impetus to develop a 24-week intervention guided by an innovative three-level Prevention Protection and Progression Health Apps for Post-Pandemic Years here-and-after as HAPPY driven by the Transactional Model of Stress and Coping Theory TMSCT to address COVID-related physical and psychosocial distress symptoms of people during the post-pandemic era The TMSCT emphasizes the use of appraisals to evaluate the harm threats and challenges that result in the process of coping with stressful events The level of stress experienced in the form of thoughts emotions and behaviours as a result of external stressors depends on appraisals of the situation which involves a judgement about whether the internal or external demands exceed an individuals resources and ability to cope when the demands exceed the resources Positive emotions will be elicited when individuals are capable of resolving stressors with the utilisation of both internal eg cognitive appraisals emotion regulation and external resources eg social support access to new knowledge and skills while negative emotions will be elicited as a result of unresolved distress
This protocol aims to evaluate the immediate effects eight weeks after weekly supervised sessions ie on the 8th week and the mid-term effects six months when the intervention has been completed ie on the 24th week of the HAPPY for alleviating peoples physiological and psychosocial distress during the post-pandemic era It is hypothesised that the experimental group will 1 exhibit greater improvement in physiological and psychosocial distress and 2 have a more positive appraisal mindset greater self-efficacy and more sustainable self-management ability than participants in the waitlist control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None