NCT06136468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 13, 2023

Last Update Submit

February 6, 2024

Conditions

Keywords

Health enhancing physical activityVirtual coach

Outcome Measures

Primary Outcomes (5)

  • Change in Physical Status as assessed by the 6 minute walk test

    6-minute walk test

    baseline; 2 weeks, 4 weeks

  • Change in Cognitive Status as assessed by the Montreal Cognitive Assessment (MoCA)

    Montreal Cognitive Assessment, 0-30 scores, higher scores mean a better outcome

    baseline; 2 weeks, 4 weeks

  • System Usability as assessed by the Post Study System Usability Questionnaire

    Post Study System Usability Questionnaire measure is scored on a 0-100 scale, and a higher score means a better outcome. This questionnaire contains 16 items on a 7-point likert.

    after intervention up to 1 week

  • Technology Acceptance as assessed by the Unified Theory of Acceptance and Use Technology (UTAUT) Questionnaire

    Unified Theory of Acceptance and Use Technology (UTAUT) Questionnaire is a 8-construct, 31-item questionnaire. The items are measure along a 7-point Likert scale, which ranges from "strongly agree" (1) to "strongly disagree" (7)

    after intervention up to 1 week

  • Change in Health related quality of life as assessed by the Short Form 8 (SF-8) Questionnaire

    SF-8 Questionnaire is a 2-construct, 8-item questionnaire assessing mental and physical health scores which is measures using 6 point scale: (0) Poor to (6) Excellent

    baseline; 2 weeks, 4 weeks

Secondary Outcomes (5)

  • Health behavior

    baseline

  • Geriatric Depression as assessed by Geriatric Depression Scale

    baseline

  • Sleep Quality as assessed by Pittsburgh Sleep Quality Index

    baseline

  • Anxiety Symptoms as assessed by Spielberger State-Trait Inventory (STAI)

    baseline

  • Demographics and Literacy as assessed by researcher-made questionnaire.

    baseline

Study Arms (2)

Experimental

EXPERIMENTAL

Exercise program using the "virtual coach" projected through head-mounted display

Behavioral: Virtual coach

No Intervention

NO INTERVENTION

Usual exercise program

Interventions

Virtual coachBEHAVIORAL

The virtual coch will be displayed to the participants using an optical see-through head-mounted display

Experimental

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quezon City Senior Citizens Affairs

Quezon City, NCR, 1118, Philippines

Location

Valenzuela Senior Citizens Affairs

Valenzuela, NCR, 1440, Philippines

Location

Related Publications (2)

  • Dino MJS, Dion KW, Abadir PM, Budhathoki C, Balbin PT, Malacas MKG, Hernandez RP, Nicolas JJG, Barcial-Espinosa J, Himmelfarb CRD, Davidson PM, Thiamwong L. Community-Dwelling Filipino Older Adults' Experiences with Virtual Coach for Health-Enhancing Physical Activity (HEPA): A Phenomenology. Nurs Rep. 2025 Jan 31;15(2):49. doi: 10.3390/nursrep15020049.

  • Dino MJS, Dion KW, Abadir PM, Budhathoki C, Huang CM, Padula WV, Himmelfarb CRD, Davidson PM. The impact of a mixed reality technology-driven health enhancing physical activity program among community-dwelling older adults: a study protocol. Front Public Health. 2024 May 14;12:1383407. doi: 10.3389/fpubh.2024.1383407. eCollection 2024.

Study Officials

  • Cheryl Himmelfarb, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

October 14, 2023

Primary Completion

January 10, 2024

Study Completion

January 20, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations