Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136468
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2023-11-13
Brief Title:
Humanoid-Technology Driven Health Enhancing Physical Activity
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Understanding the Impact of Humanoid Technology HT Driven Health Enhancing Physical Activity HEPA Program Among Community-Dwelling Filipino Older Adults
Status:
COMPLETED
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:
Ensuring the health and well-being of older individuals is a global problem The application of emerging technology is increasingly advocated to improve health outcomes yet the investigators need to identify how feasible and acceptable this is among users One example of these emerging technologies is humanoid technologies Humanoid technologies are human-resembling digital objects that can be projected using head-mounted displays to be worn by users This study seeks to assess the impact of humanoid technologies HTs in the form of digital health coaches to enhance the physical activity of community-dwelling older adults in the Philippines The quasi-experimental study will assess the participants intention for technology use and the participants experience of the intervention acceptability barriers and facilitators Specifically this study will compare the impact of the Humanoid Technology-driven Health Enhancing Physical Activity program versus a standard physical activity program video-based on physical performance cognitive function and quality of life among older adults in two senior centers in the Philippines The study will also identify older adults preferences for an ideal Humanoid Technology-driven Health Enhancing Physical Activity and the participants intention to use it via survey An embedded qualitative study will explore participants perceptions of the acceptability barriers and facilitators of the Humanoid Technology-driven Health Enhancing Physical Activity program
Detailed Description:
A quasi-experimental research design with embedded qualitative interviews will be used to understand the impact of Humanoid Technology-driven Health Enhancing Physical Activity among community-dwelling Filipino older adults and compare the effects of Humanoid Technology-driven Health Enhancing Physical Activity versus the current Health Enhancing Physical Activity live coaching and video-based on the participants physical cognitive status and Quality of Life
The investigators will assess the preferences of the older adults prior to the intervention to identify the participants specific wishes and choices eg music gender of the humanoid technology coach To achieve this the investigators will follow the conjoint analysis methods in healthcare as follows a defining intervention attributes and levels based on literature evidence and b designing the attributes and levels as components of the program and c designing the conjoint survey questionnaire The computer-based survey questionnaire using the Sawtooth software will be distributed to participants
The investigators have identified two community senior centers affiliated with the local government unit to participate in this quasi-experimental study One community senior center will serve as the experimental site and the second community senior center will serve as the control site Older adults will be recruited at each site for study participation
The eligible participants will be purposively selected from the regular attendees at the study sites using the inclusion criteria 1 ambulatory 2 can follow simple instructions 3 normal eyes functioning without low vision or at most with corrective lenses and 4 willingness to participate in the program with signed informed consent Older adults who are considered not suitable to participate by the community physician using the local guidelines will be excluded A total of 128 or 64 older adults in each center will be recruited via posters at community senior centers Afterward the treatments will be assigned to each of the two senior center sites for the quasi-experimental study Only the participants from the experimental group shall be involved in the usability evaluations and six from the experimental group for the qualitative study
The intervention period will run for 1 month consisting of the first two weeks of the twice-weekly Tuesday and Thursday schedule to be followed by the second 2 weeks of three times weekly Monday Wednesday Friday schedule Each session will last approximately 15 hours including orientation warm-up and stretching All participants will be supervised by the health team and trained personnel at the senior center and follow a standard protocol The investigators will compare the participants physical cognitive status and Quality of Life measures before and after the intervention using standardized methods
After the intervention the investigators will ask the older adults in the experimental group to answer a survey related to the usability of the program and the participants intention to participate in the program in the future The investigators will select six participants from the experimental group for an interview to know the participants perception of the intervention particularly related to its acceptability barriers and facilitator
As with other studies involving technologies potential risks include loss of autonomy privacy data protection safety isolation prevention and user over-stressing To minimize the risks proper orientation will be held The research team will undergo training and acquire good clinical practice certificate Procedures will align with the currently accepted standards by the local Philippine Department of Health the research team will recruit social workers and healthcare providers to monitor the interventions and for potential health and wellness issues during the study Reporting untoward events will comply with the current protocol and standards
The investigators will assess the preferences of the older adults prior to the intervention to identify the participants specific wishes and choices eg music gender of the humanoid technology coach To achieve this the investigators will follow the conjoint analysis methods in healthcare as follows a defining intervention attributes and levels based on literature evidence and b designing the attributes and levels as components of the program and c designing the conjoint survey questionnaire The computer-based survey questionnaire using the Sawtooth software will be distributed to participants
The investigators have identified two community senior centers affiliated with the local government unit to participate in this quasi-experimental study One community senior center will serve as the experimental site and the second community senior center will serve as the control site Older adults will be recruited at each site for study participation
The eligible participants will be purposively selected from the regular attendees at the study sites using the inclusion criteria 1 ambulatory 2 can follow simple instructions 3 normal eyes functioning without low vision or at most with corrective lenses and 4 willingness to participate in the program with signed informed consent Older adults who are considered not suitable to participate by the community physician using the local guidelines will be excluded A total of 128 or 64 older adults in each center will be recruited via posters at community senior centers Afterward the treatments will be assigned to each of the two senior center sites for the quasi-experimental study Only the participants from the experimental group shall be involved in the usability evaluations and six from the experimental group for the qualitative study
The intervention period will run for 1 month consisting of the first two weeks of the twice-weekly Tuesday and Thursday schedule to be followed by the second 2 weeks of three times weekly Monday Wednesday Friday schedule Each session will last approximately 15 hours including orientation warm-up and stretching All participants will be supervised by the health team and trained personnel at the senior center and follow a standard protocol The investigators will compare the participants physical cognitive status and Quality of Life measures before and after the intervention using standardized methods
After the intervention the investigators will ask the older adults in the experimental group to answer a survey related to the usability of the program and the participants intention to participate in the program in the future The investigators will select six participants from the experimental group for an interview to know the participants perception of the intervention particularly related to its acceptability barriers and facilitator
As with other studies involving technologies potential risks include loss of autonomy privacy data protection safety isolation prevention and user over-stressing To minimize the risks proper orientation will be held The research team will undergo training and acquire good clinical practice certificate Procedures will align with the currently accepted standards by the local Philippine Department of Health the research team will recruit social workers and healthcare providers to monitor the interventions and for potential health and wellness issues during the study Reporting untoward events will comply with the current protocol and standards
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