Clinical trial NCT06136468: Humanoid-Technology Driven Health Enhancing Physical Activity
Official title: Understanding the Impact of Humanoid Technology (HT) Driven Health Enhancing Physical Activity (HEPA) Program Among Community-Dwelling Filipino Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-dwelling Older Adults
Keywords: Health enhancing physical activity
Virtual coach
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 130
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (e.g., 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 1.5 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.

Eligibility criteria: Inclusion Criteria:

* ambulatory
* can follow simple instructions
* normal eyes functioning without low vision (or at most with corrective lenses), (4) willingness to participate in the program with signed informed consent

Exclusion Criteria:

* non-ambulatory
* not suitable to participate as certified by a community physician

Primary outcomes:
measure: Change in Physical Status as assessed by the 6 minute walk test
timeFrame: baseline; 2 weeks, 4 weeks
measure: Change in Cognitive Status as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: baseline; 2 weeks, 4 weeks
measure: System Usability as assessed by the Post Study System Usability Questionnaire
timeFrame: after intervention up to 1 week
measure: Technology Acceptance as assessed by the Unified Theory of Acceptance and Use Technology (UTAUT) Questionnaire
timeFrame: after intervention up to 1 week
measure: Change in Health related quality of life as assessed by the Short Form 8 (SF-8) Questionnaire
timeFrame: baseline; 2 weeks, 4 weeks
Secondary outcomes:
measure: Health behavior
timeFrame: baseline
measure: Geriatric Depression as assessed by Geriatric Depression Scale
timeFrame: baseline
measure: Sleep Quality as assessed by Pittsburgh Sleep Quality Index
timeFrame: baseline
measure: Anxiety Symptoms as assessed by Spielberger State-Trait Inventory (STAI)
timeFrame: baseline
measure: Demographics and Literacy as assessed by researcher-made questionnaire.
timeFrame: baseline
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Quezon City Senior Citizens Affairs
state: NCR
city: Valenzuela
country: Philippines
facility: Valenzuela Senior Citizens Affairs
state: NCR
Study officials:
affiliation: Johns Hopkins University
name: Cheryl Himmelfarb, PhD
role: PRINCIPAL_INVESTIGATOR
References: