Community-dwelling Older AdultsNCT06136468
Humanoid-Technology Driven Health Enhancing Physical Activity
A study testing Virtual coach in people with Community-dwelling Older Adults, run by Johns Hopkins University at 2 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Older Adults
- What is being tested?
- Virtual coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesPhilippines
- Study dates
- 14 Oct 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-ambulatory
- not suitable to participate as certified by a community physician
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Quezon City Senior Citizens Affairs
Quezon City, NCR, 1118
Valenzuela Senior Citizens Affairs
Valenzuela, NCR, 1440
About this study
Official title: Understanding the Impact of Humanoid Technology (HT) Driven Health Enhancing Physical Activity (HEPA) Program Among Community-Dwelling Filipino Older Adults
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.
Read the 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.
- Conditions
- Community-dwelling Older Adults
- Being tested
- Virtual coach
- Keywords
- Health enhancing physical activity, Virtual coach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual coachBehavioural
The virtual coch will be displayed to the participants using an optical see-through head-mounted display
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Exercise program using the "virtual coach" projected through head-mounted display Receives: Behavioral: Virtual coach |
| No Intervention | No intervention | Usual exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Status as assessed by the 6 minute walk test
6-minute walk test
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: baseline; 2 weeks, 4 weeks
Secondary outcomes (5)
Health behavior
Health behavior as assessed by Patient Action Inventory for Self-Care. It consists of 57 items. Participants were asked to indicate Yes or No for each action statement from three perspectives: 1) Is this important to you? 2) Do you want to do this? 3) Are you able to do this?. For each action item, the mean value will be used to describe the percentage of the participants answered Yes as 1 versus No as 0; and 2) by each of the three perspectives - importance, desirability, and perceived ability. The ranks are indicated from the highest to the lowest percentage, where Rank 1 indicates the item that most participants indicated with Yes. The arithmetic mean will be used as a measure of importance, desire, and ability levels for each action item.
Measured: baseline
Geriatric Depression as assessed by Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a 15-item self-report measure of depression in older adults where subjects respond in a Yes/No format. Out of the 15 items, 10 indicate the presence of depression when answered positively, while the other 5 are indicative of depression when answered negatively. The form can be completed in approximately 5 to 7 minutes, making it ideal for people who are easily fatigued or are limited in their ability to concentrate for more extended periods of time.
Measured: baseline
Sleep Quality as assessed by Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. The score ranges from 0-21. Scores higher than 5 indicate poor sleep quality.
Measured: baseline
Anxiety Symptoms as assessed by Spielberger State-Trait Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: baseline
Demographics and Literacy as assessed by researcher-made questionnaire.
Consists of residence, gender, age, marital status, education, and self-rated technology literacy/competency and general health
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 Oct 2023
- Primary completion10 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling Older AdultsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Himmelfarb, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136468
- Sponsor's protocol ID
- IRB00347131
- Status last verified
- Feb 2024
- First submitted
- 13 Nov 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39997785Dino 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.
PubMed 38807990
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Humanoid Technology (HT) Driven Health Enhancing Physical Activity (HEPA) Program Among Community-Dwelling Filipino Older Adults
- ClinicalTrials.gov ID
- NCT06136468
- Acronym / sponsor ID
- IRB00347131
- Conditions
- Community-dwelling Older Adults
- Keywords
- Health enhancing physical activity, Virtual coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Virtual coachExercise program using the "virtual coach" projected through head-mounted display |
| No Intervention | No intervention | –Usual exercise program |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- non-ambulatory
- not suitable to participate as certified by a community physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual coachThe virtual coch will be displayed to the participants using an optical see-through head-mounted display | Behavioural | Experimental |
Primary outcome
Change in Physical Status as assessed by the 6 minute walk test
Time frame: baseline; 2 weeks, 4 weeks
6-minute walk test
Change in Cognitive Status as assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: baseline; 2 weeks, 4 weeks
Montreal Cognitive Assessment, 0-30 scores, higher scores mean a better outcome
System Usability as assessed by the Post Study System Usability Questionnaire
Time frame: after intervention up to 1 week
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.
Technology Acceptance as assessed by the Unified Theory of Acceptance and Use Technology (UTAUT) Questionnaire
Time frame: after intervention up to 1 week
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)
Change in Health related quality of life as assessed by the Short Form 8 (SF-8) Questionnaire
Time frame: baseline; 2 weeks, 4 weeks
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
5 secondary outcomes
Health behavior
Time frame: baseline
Geriatric Depression as assessed by Geriatric Depression Scale
Time frame: baseline
Sleep Quality as assessed by Pittsburgh Sleep Quality Index
Time frame: baseline
Anxiety Symptoms as assessed by Spielberger State-Trait Inventory (STAI)
Time frame: baseline
Demographics and Literacy as assessed by researcher-made questionnaire.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 39997785Dino 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.
- Derived from this study: PubMed 38807990Dino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Himmelfarb, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual coach in people with Community-dwelling Older Adults, run by Johns Hopkins University at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Status as assessed by the 6 minute walk test (time frame: baseline; 2 weeks, 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136468, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.