FrailtyNCT07740031
Development of a Frailty Risk Prediction Model and Preliminary Evaluation of a Risk-stratified Social Robot-assisted Intervention in Middle-aged and Older Spousal Caregivers
A study testing Virtual social robot-assisted intervention in people with Frailty, run by The Hong Kong Polytechnic University.
Trial summary
Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Virtual social robot-assisted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 50 years or older
- currently being a spouse caregiver
- assessed as being at high risk level frailty by the developed online risk calculator
- being able to use the social robot through a smartphone or tablet, either independently or with necessary guidance
- willing to sign informed consent and participate in study
Who cannot join
- those with acute mental disorders or disabling diseases that may limit the practice of engaging with a robot
- acute disease attack or acute medical condition
- currently participating in another intervention or clinical trial
- who have limited access to electricity, which would make it hard for them to use technology at home
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Older family caregivers are particularly susceptible to frailty because they shoulder substantial caregiving responsibilities while simultaneously experiencing their own age-related decline in health and physiological reserve. Frailty is a clinically important state of heightened vulnerability to stressors and is associated with serious adverse outcomes, including disability, hospitalisation, and mortality. In family caregivers, frailty may compromise not only health and quality of life, but also their capacity to sustain caregiving, with wider implications for the sustainability of family-based long-term care.
Research gaps A scoping review conducted by this team indicated that middle-aged and older family caregivers, particularly spousal caregivers, are vulnerable to frailty, with caregiving-related, sociodemographic, physical, psychological, and social factors contributing to this condition. However, existing evidence remains fragmented. Caregiver-specific prognostic tools for estimating future frailty risk are lacking, and risk-stratified interventions among family caregivers are sparse.
Read more
Aim This study aims to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers, identify modifiable risk factors, as well as develop and preliminarily evaluate a risk-stratified, social robot-assisted intervention to reduce the risk of frailty.
Methods This study comprises four phases. Phase 1 is a completed scoping review that mapped evidence on frailty among middle-aged and older family caregivers. Phase 2 will use longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS) to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers and to construct an online risk calculator. Phase 3 will develop social robot-assisted intervention based on the Capability, Opportunity, Motivation-Behavior (COM-B) model. Phase 4 will assess the feasibility, acceptability, and examine preliminary effects of the intervention.
Expected outcomes This study is expected to provide a caregiver-specific tool for early frailty risk identification and risk stratification among middle-aged and older spousal caregivers. It will also generate a theoretically guided, risk-stratified social robot-assisted intervention targeting modifiable risk factors for frailty and provide evidence on its feasibility and acceptability, as well as preliminary effects. The findings will inform a future definitive large-scale trial and community-based caregiver support services.
- Conditions
- Frailty
- Being tested
- Virtual social robot-assisted intervention, Wait-list control group
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual social robot-assisted interventionBehavioural
A virtual social robot-assisted intervention will be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period.
Wait-list control groupBehavioural
Participants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| social robot-assisted intervention | Experimental | A social robot-assisted intervention wii be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period. Receives: Behavioral: Virtual social robot-assisted intervention |
| Wait-list control group | Placebo comparator | Participants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment. Receives: Behavioral: Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Robot-use adherence rate
Robot-use adherence will be assessed using automatically recorded robot usage logs. Adherence will be calculated for each participant as the number of prescribed robot-use sessions completed divided by the total number of robot-use sessions prescribed during the 6-week intervention period, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence to the prescribed robot-use schedule.
Measured: Throughout the 6-week intervention period
Robot-use frequency
Robot-use frequency will be assessed using automatically recorded robot usage logs. A robot-use session will be defined as one recorded episode of interaction with the robot. The number of robot-use sessions completed by each participant will be summarized as the mean number of sessions per week across the 6-week intervention period. A higher number indicates more frequent robot use.
Measured: Throughout the 6-week intervention period
Participant retention rate
The participant retention rate will be calculated as the number of enrolled participants who remain in the study and have not withdrawn by Week 6 divided by the total number of participants enrolled, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater participant retention.
Measured: Week 6
The follow-up assessment completion rate
The follow-up assessment completion rate will be calculated as the number of participants who complete the scheduled Week 6 follow-up assessment divided by the total number of enrolled participants expected to complete the assessment, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater follow-up completion.
Measured: Week 6
Acceptability of the robot-based intervention assessed by semi-structured interviews
All participants in the intervention group will be invited to participate in an individual semi-structured interview at Week 6. Interviews will explore participants' experiences of using the robot at home and their perceptions of the acceptability of the intervention. Interview data will be analyzed using thematic analysis and reported as themes and subthemes related to participants' experiences and perceived acceptability. No numerical scale score will be calculated.
Measured: Week 6, following completion of the intervention
Secondary outcomes (4)
Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire
Capability, opportunity, and motivation to engage in frailty risk-management behaviours will be assessed using the Adapted 6-item Capability, Opportunity, Motivation-Behaviour Self-Evaluation Questionnaire (Keyworth et al., 2020). The questionnaire contains six items assessing physical capability, psychological capability, physical opportunity, social opportunity, reflective motivation, and automatic motivation. Each item is rated from 0 to 10. Item scores will be summed to produce a total score ranging from 0 to 60. Higher scores indicate greater overall perceived capability, opportunity, and motivation to engage in frailty risk-management behaviours.
Measured: Baseline and Week 6
Fried's frailty phenotype
Frailty will be assessed using Fried's frailty phenotype, which includes five criteria: slowness, weakness, unintentional weight loss, low physical activity, and exhaustion. One point will be assigned for each criterion present, resulting in a total score ranging from 0 to 5. Participants will be classified as non-frail if no criteria are present, pre-frail if one or two criteria are present, and frail if three or more criteria are present. Higher scores indicate a greater level of frailty.
Measured: Baseline and Week 6
Frailty Risk Probability
Individual frailty risk probability will be estimated using the online frailty calculator developed by our team.
Measured: Baseline and Week 6
Modifiable Frailty Risk-Factor Indicator
Based on the modifiable risk factors identified in phase 3, indicators may include physical activity, sleep quality, nutritional status, depression, social support, and caregiver intensity. Appropriate validated scales will be used for modifiable risk factor.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740031
- Sponsor's protocol ID
- S001856
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Frailty Risk Prediction Model and Preliminary Evaluation of a Risk-stratified Social Robot-assisted Intervention in Middle-aged and Older Spousal Caregivers
- ClinicalTrials.gov ID
- NCT07740031
- Acronym / sponsor ID
- S001856
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 31 Jul 2026 (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.
Background With population ageing accelerating worldwide, long-term care needs are rising, and family caregivers have become an essential yet often under-recognised component of care systems. Older family caregivers are particularly susceptible to frailty because they shoulder substantial caregiving responsibilities while simultaneously experiencing their own age-related decline in health and physiological reserve. Frailty is a clinically important state of heightened vulnerability to stressors and is associated with serious adverse outcomes, including disability, hospitalisation, and mortality. In family caregivers, frailty may compromise not only health and quality of life, but also their capacity to sustain caregiving, with wider implications for the sustainability of family-based long-term care.
Research gaps A scoping review conducted by this team indicated that middle-aged and older family caregivers, particularly spousal caregivers, are vulnerable to frailty, with caregiving-related, sociodemographic, physical, psychological, and social factors contributing to this condition. However, existing evidence remains fragmented. Caregiver-specific prognostic tools for estimating future frailty risk are lacking, and risk-stratified interventions among family caregivers are sparse.
Aim This study aims to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers, identify modifiable risk factors, as well as develop and preliminarily evaluate a risk-stratified, social robot-assisted intervention to reduce the risk of frailty.
Methods This study comprises four phases. Phase 1 is a completed scoping review that mapped evidence on frailty among middle-aged and older family caregivers. Phase 2 will use longitudinal data from the China Health and Retirement Longitudinal Study (CHARLS) to develop and validate an incident frailty risk prediction model for middle-aged and older spousal caregivers and to construct an online risk calculator. Phase 3 will develop social robot-assisted intervention based on the Capability, Opportunity, Motivation-Behavior (COM-B) model. Phase 4 will assess the feasibility, acceptability, and examine preliminary effects of the intervention.
Expected outcomes This study is expected to provide a caregiver-specific tool for early frailty risk identification and risk stratification among middle-aged and older spousal caregivers. It will also generate a theoretically guided, risk-stratified social robot-assisted intervention targeting modifiable risk factors for frailty and provide evidence on its feasibility and acceptability, as well as preliminary effects. The findings will inform a future definitive large-scale trial and community-based caregiver support services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| social robot-assisted intervention | Experimental | Behavioral: Virtual social robot-assisted interventionA social robot-assisted intervention wii be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period. |
| Wait-list control group | Placebo comparator | Behavioral: Wait-list control groupParticipants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 50 years or older
- currently being a spouse caregiver
- assessed as being at high risk level frailty by the developed online risk calculator
- being able to use the social robot through a smartphone or tablet, either independently or with necessary guidance
- willing to sign informed consent and participate in study
Key exclusion criteria (4 listed)
- those with acute mental disorders or disabling diseases that may limit the practice of engaging with a robot
- acute disease attack or acute medical condition
- currently participating in another intervention or clinical trial
- who have limited access to electricity, which would make it hard for them to use technology at home
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 social robot-assisted interventionA virtual social robot-assisted intervention will be provided to participants. Participants will be encouraged to engage with the virtual social robot 3 times per week, with each structured session lasting approximately 20 minutes, over a 6-week intervention period. | Behavioural | social robot-assisted intervention |
| Wait-list control groupParticipants allocated to the wait-list control group will receive delayed access to the virtual social robot intervention after completion of the final follow-up assessment. | Behavioural | Wait-list control group |
Primary outcome
Robot-use adherence rate
Time frame: Throughout the 6-week intervention period
Robot-use adherence will be assessed using automatically recorded robot usage logs. Adherence will be calculated for each participant as the number of prescribed robot-use sessions completed divided by the total number of robot-use sessions prescribed during the 6-week intervention period, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence to the prescribed robot-use schedule.
Robot-use frequency
Time frame: Throughout the 6-week intervention period
Robot-use frequency will be assessed using automatically recorded robot usage logs. A robot-use session will be defined as one recorded episode of interaction with the robot. The number of robot-use sessions completed by each participant will be summarized as the mean number of sessions per week across the 6-week intervention period. A higher number indicates more frequent robot use.
Participant retention rate
Time frame: Week 6
The participant retention rate will be calculated as the number of enrolled participants who remain in the study and have not withdrawn by Week 6 divided by the total number of participants enrolled, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater participant retention.
The follow-up assessment completion rate
Time frame: Week 6
The follow-up assessment completion rate will be calculated as the number of participants who complete the scheduled Week 6 follow-up assessment divided by the total number of enrolled participants expected to complete the assessment, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater follow-up completion.
Acceptability of the robot-based intervention assessed by semi-structured interviews
Time frame: Week 6, following completion of the intervention
All participants in the intervention group will be invited to participate in an individual semi-structured interview at Week 6. Interviews will explore participants' experiences of using the robot at home and their perceptions of the acceptability of the intervention. Interview data will be analyzed using thematic analysis and reported as themes and subthemes related to participants' experiences and perceived acceptability. No numerical scale score will be calculated.
4 secondary outcomes
Adapted 6-item Capability, Opportunity, Motivation-Behaviour (COM-B) Self-Evaluation Questionnaire
Time frame: Baseline and Week 6
Fried's frailty phenotype
Time frame: Baseline and Week 6
Frailty Risk Probability
Time frame: Baseline and Week 6
Modifiable Frailty Risk-Factor Indicator
Time frame: Baseline and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual social robot-assisted intervention in people with Frailty, run by The Hong Kong Polytechnic University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivy Yan Zhao (+8527664550, yan-ivy.zhao@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Robot-use adherence rate (time frame: Throughout the 6-week intervention period). 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?
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 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.