DementiaNCT07889635
The Effects of an Empower_ICE-Fit Program in PLwD Living at Home
A study testing empowerment-based Intrinsic capacity-Environment Fit in people with Dementia, run by The University of Hong Kong at 2 sites in China.
Trial summary
The purpose of this study is to see if the Empower-ICE_Fit program can help people with dementia live more safely, comfortably, and independently at home. This program is designed to better match a person's physical and mental abilities (intrinsic capacity) with their living space (environment) through targeted home… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- empowerment-based Intrinsic capacity-Environment Fit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2026to 1 Mar 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PLwD inclusion criteria:
- Aged 60 years or above and living in a private residence, with no plan to relocate within the following six months.
- A documented diagnosis of mild dementia, operationalized as a Clinical Dementia Rating global score of 1.
- The PLwD is either not taking any dementia-related medication or has been on a stable dementia-related medication regimen for at least three months prior to the baseline assessment.
- Able to communicate in Mandarin and able to read and write Chinese, if confirmed as required for study participation.
- Able and willing to participate in study assessments and intervention procedures, with appropriate caregiver support.
Caregiver inclusion criteria:
- Aged 18 years or above.
- An unpaid primary family caregiver providing at least 20 hours of care per week.
- Able to communicate in Mandarin and read and write Chinese.
- Able to use a smartphone or tablet for video calls and digital study materials.
- Willing to participate in the intervention sessions and assessments and provide separate written informed consent.
PLwD exclusion criteria：
- Acute medical crisis, unstable systemic disease, recent stroke, severe psychiatric disorder, or cognitive impairment primarily attributable to Parkinson's disease or another neurological condition outside the study scope.
- Current participation in another structured home-environment modification or non-pharmacological behavioural intervention.
- Severe uncorrected hearing or visual impairment that prevents participation despite reasonable accommodation.
- A health condition that makes participation in the assessments or intervention unsafe.
Caregiver exclusion criteria：
- Unable or unwilling to participate in the intervention sessions or assessments.
- Significant cognitive, psychiatric, communication or sensory difficulty preventing informed participation.
- Unable to use the required telephone or online communication tools and without another feasible arrangement.
Home-related exclusion：
(1) The residence contains immediate major structural, electrical or fire hazards outside the scope of the non-structural intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shandong Medical and Pharmaceutical University Hospital
Binzhou, Shandong
Xuezhen Wang, 0086+13561585346, honey991113@163.com
Shandong Provincial Hospital
Jinan, Shandong
xia Chen, 0086+15320634535, 1922661512@qq.com
About this study
Official title: The Effects of an Empowerment-based Intrinsic Capacity-Environment Fit Program in People With Dementia Living at Home
The purpose of this study is to see if the Empower-ICE_Fit program can help people with dementia live more safely, comfortably, and independently at home. This program is designed to better match a person's physical and mental abilities (intrinsic capacity) with their living space (environment) through targeted home environmental assessment and home modification counseling.
As a multiphase mixed-methods study, researchers will collect both numerical health data and personal interview feedback to fully understand how the program works.
Read more
The main questions this study aims to answer are:
Does the Empower-ICE_Fit program improve the daily functional performance of people with dementia?
Does this empowerment-based approach help improve the quality of life for both the individuals and their family caregivers?
In this study, researchers will:
Assess the current home environments and daily functioning of the participants using specific home environment screening measures.
Provide tailored home modification recommendations with empowerment-based approach.
Compare the health and safety outcomes of participants in the Empower-ICE_Fit program with those receiving standard care.
Conduct interviews to deeply understand the personal experiences and challenges of participants and their caregivers during the process.
Participants will be asked to complete regular health assessments (including both professionally guided and self-reported measures) and may be invited to share their care experiences in interviews.
Read the detailed description
This is a prospective, two-arm, assessor-blinded randomized controlled trial with an embedded qualitative component. A total of 152 people living with dementia-caregiver dyads will be randomly allocated in a 1:1 ratio to the Empower-ICE_Fit intervention group or an active control group.
The intervention group will participate in an eight-week empowerment-based home-modification program. The program includes one approximately 90-minute home visit, three individual online counselling sessions of approximately 30-45 minutes each, three telephone or WeChat follow-ups, and one booster online session. The program combines assessment of intrinsic capacity and the home environment with collaborative goal setting, empowerment coaching, and tailored home-modification recommendations.
The control group will continue to receive usual care and will receive a standardized home-safety education booklet at baseline. It will not receive the individualized assessment, empowerment coaching, tailored home-modification counselling, or follow-up sessions included in the Empower-ICE_Fit program.
Outcomes will be assessed at baseline, immediately after the eight-week intervention, and at the Week 12 follow-up. Approximately 10 dyads from the intervention group will also be purposively selected for semi-structured interviews exploring their experiences, engagement, and perceptions of the program.
- Conditions
- Dementia
- Being tested
- empowerment-based Intrinsic capacity-Environment Fit, Usual Care Group
- Keywords
- Intrinsic Capacity, Home Modification, Empowerment, Home Safety, Person-Environment Fit
- Medical subject headings
- Dementia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empowerment-based Intrinsic capacity-Environment FitBehavioural
Also called Empower-ICE_Fit Program
The Empower-ICE_Fit program is a multicomponent, empowerment-based intervention designed to optimize the fit between a person's intrinsic capacity and their home environment. The intervention distinguishes itself by integrating targeted home modification recommendations with empowerment coaching for people with dementia and their caregivers. Key components include:
Comprehensive Assessments: Conducting rigorous environmental screenings utilizing targeted instruments, specifically differentiating between the clinician-led HOME FAST professional tool and the Self-report HOME FAST version to capture both professional and user-centric perspectives.
Empowerment Coaching: Providing structured guidance and education to enhance caregivers' and patients' capacity to manage home modification independently.
Tailored Environmental Modifications: Delivering personalized counseling to adapt the living space to the specific needs of the individual, thereby promoting health aging.
Usual Care GroupOther
Participants in this group will receive the standard routine care and usual community support services available to individuals with dementia. This includes general health education and standard clinical follow-ups. This standard care does not include the specialized, structured empowerment coaching or the personalized Intrinsic capacity-Environment Fit assessments and tailored home modification recommendations provided in the experimental Empower-ICE_Fit program.
| Study group | Role | What they receive |
|---|---|---|
| Empower-ICE_Fit Program | Experimental | Participants assigned to this arm will receive the empowerment-based Intrinsic capacity-Environment Fit (Empower-ICE_Fit) program. This multidimensional intervention includes comprehensive assessments of the individual's intrinsic capacity and home environment. Based on the assessment, participants and their family caregivers will receive tailored home modification recommendations and targeted guidance to optimize the person-environment fit, enhance independence, and improve overall quality of life at home. Receives: Behavioral: empowerment-based Intrinsic capacity-Environment Fit |
| Usual Care | Active comparator | Participants assigned to this arm will receive standard routine care and general health education materials typically provided to individuals with dementia and their caregivers. They will not receive the specific empowerment coaching, structured intrinsic capacity assessments, or tailored home modification interventions provided in the Empower-ICE_Fit program during the study period. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Performance (A-IADL-Q-SV)
Functional performance is evaluated using the Chinese version of the Amsterdam IADL Questionnaire-Short Version (A-IADL-Q-SV). This tool assesses the difficulties individuals experience in instrumental activities of daily living. A higher score indicates a higher level of functional performance and greater independence, representing a better outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Change in Neuropsychiatric Symptoms (NPI-Q-C)
Neuropsychiatric symptoms are evaluated using the Chinese version of the Neuropsychiatric Inventory Questionnaire (NPI-Q-C). This tool assesses 12 behavioral and psychological symptoms common in dementia. The total symptom severity score is the sum of the severity ratings for all 12 items, ranging from 0 to 36 (each item scored from 0 to 3). A higher score indicates more severe neuropsychiatric symptoms, representing a worse outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Change in Social Engagement and Independence (EID-Q-C)
Social engagement and independence are evaluated using the Chinese version of the Engagement and Independence in Dementia Questionnaire (EID-Q-C). This tool assesses the individual's level of meaningful activity and social interaction. A higher score indicates a greater level of social engagement and independence, representing a better outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Secondary outcomes (4)
Change in Participant Quality of Life (QoL-AD)
Participant quality of life is evaluated using the Quality of Life in Alzheimer's Disease (QoL-AD) scale. This tool assesses various domains of well-being, including physical health, mood, and relationships. Assuming the standard 13-item version is used, the total score ranges from 13 to 52. A higher score indicates a better quality of life, representing a better outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Change in Caregiver Quality of Life (SF-12)
Caregiver health-related quality of life is evaluated using the 12-Item Short Form Health Survey (SF-12). This survey yields a Physical Component Summary (PCS) and a Mental Component Summary (MCS). Scores are typically transformed and standardized to range from [0] to [100]. A higher score indicates a better physical and mental health status, representing a better outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Change in Fear of Falling (FES-I)
The fear of falling is evaluated using the Falls Efficacy Scale-International (FES-I). This tool assesses an individual's concern about falling during 16 physical and social activities. The total score ranges from 16 to 64. A higher score indicates a greater fear of falling and lower confidence in performing daily activities, representing a worse outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Change in Caregiver Burden (ZBI)
Caregiver burden is evaluated using the Zarit Burden Interview (ZBI). This tool assesses the physical, psychological, and social stresses experienced by family caregivers. Assuming the short 12-item version is used, the total score ranges from 0 to 48. A higher score indicates a greater level of perceived caregiver burden, representing a worse outcome.
Measured: Baseline, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- People living with dementia-caregiver dyads will be randomly allocated in a 1:1 ratio to either the Empower-ICE\_Fit intervention group or the active control group receiving standardized home-safety education. Outcome assessments will be conducted at baseline, Week 8, and Week 12.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUANG Yanan, The University of Hong Kong
- Investigators
- Yanan HUANG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889635
- Sponsor's protocol ID
- UW 26-379
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Empowerment-based Intrinsic Capacity-Environment Fit Program in People With Dementia Living at Home
- ClinicalTrials.gov ID
- NCT07889635
- Acronym / sponsor ID
- UW 26-379
- Conditions
- Dementia
- Keywords
- Intrinsic Capacity, Home Modification, Empowerment, Home Safety, Person-Environment Fit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Oct 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.
The purpose of this study is to see if the Empower-ICE_Fit program can help people with dementia live more safely, comfortably, and independently at home. This program is designed to better match a person's physical and mental abilities (intrinsic capacity) with their living space (environment) through targeted home environmental assessment and home modification counseling.
As a multiphase mixed-methods study, researchers will collect both numerical health data and personal interview feedback to fully understand how the program works.
The main questions this study aims to answer are:
Does the Empower-ICE_Fit program improve the daily functional performance of people with dementia?
Does this empowerment-based approach help improve the quality of life for both the individuals and their family caregivers?
In this study, researchers will:
Assess the current home environments and daily functioning of the participants using specific home environment screening measures.
Provide tailored home modification recommendations with empowerment-based approach.
Compare the health and safety outcomes of participants in the Empower-ICE_Fit program with those receiving standard care.
Conduct interviews to deeply understand the personal experiences and challenges of participants and their caregivers during the process.
Participants will be asked to complete regular health assessments (including both professionally guided and self-reported measures) and may be invited to share their care experiences in interviews.
Detailed description
This is a prospective, two-arm, assessor-blinded randomized controlled trial with an embedded qualitative component. A total of 152 people living with dementia-caregiver dyads will be randomly allocated in a 1:1 ratio to the Empower-ICE_Fit intervention group or an active control group.
The intervention group will participate in an eight-week empowerment-based home-modification program. The program includes one approximately 90-minute home visit, three individual online counselling sessions of approximately 30-45 minutes each, three telephone or WeChat follow-ups, and one booster online session. The program combines assessment of intrinsic capacity and the home environment with collaborative goal setting, empowerment coaching, and tailored home-modification recommendations.
The control group will continue to receive usual care and will receive a standardized home-safety education booklet at baseline. It will not receive the individualized assessment, empowerment coaching, tailored home-modification counselling, or follow-up sessions included in the Empower-ICE_Fit program.
Outcomes will be assessed at baseline, immediately after the eight-week intervention, and at the Week 12 follow-up. Approximately 10 dyads from the intervention group will also be purposively selected for semi-structured interviews exploring their experiences, engagement, and perceptions of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- People living with dementia-caregiver dyads will be randomly allocated in a 1:1 ratio to either the Empower-ICE_Fit intervention group or the active control group receiving standardized home-safety education. Outcome assessments will be conducted at baseline, Week 8, and Week 12.
| Arm | Type | Receives |
|---|---|---|
| Empower-ICE_Fit Program | Experimental | Behavioral: empowerment-based Intrinsic capacity-Environment FitParticipants assigned to this arm will receive the empowerment-based Intrinsic capacity-Environment Fit (Empower-ICE_Fit) program. This multidimensional intervention includes comprehensive assessments of the individual's intrinsic capacity and home environment. Based on the assessment, participants and their family caregivers will receive tailored home modification recommendations and targeted guidance to optimize the person-environment fit, enhance independence, and improve overall quality of life at home. |
| Usual Care | Active comparator | Other: Usual Care GroupParticipants assigned to this arm will receive standard routine care and general health education materials typically provided to individuals with dementia and their caregivers. They will not receive the specific empowerment coaching, structured intrinsic capacity assessments, or tailored home modification interventions provided in the Empower-ICE_Fit program during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| empowerment-based Intrinsic capacity-Environment FitAlso: Empower-ICE_Fit ProgramThe Empower-ICE_Fit program is a multicomponent, empowerment-based intervention designed to optimize the fit between a person's intrinsic capacity and their home environment. The intervention distinguishes itself by integrating targeted home modification recommendations with empowerment coaching for people with dementia and their caregivers. Key components include: Comprehensive Assessments: Conducting rigorous environmental screenings utilizing targeted instruments, specifically differentiating between the clinician-led HOME FAST professional tool and the Self-report HOME FAST version to capture both professional and user-centric perspectives. Empowerment Coaching: Providing structured guidance and education to enhance caregivers' and patients' capacity to manage home modification independently. Tailored Environmental Modifications: Delivering personalized counseling to adapt the living space to the specific needs of the individual, thereby promoting health aging. | Behavioural | Empower-ICE_Fit Program |
| Usual Care GroupParticipants in this group will receive the standard routine care and usual community support services available to individuals with dementia. This includes general health education and standard clinical follow-ups. This standard care does not include the specialized, structured empowerment coaching or the personalized Intrinsic capacity-Environment Fit assessments and tailored home modification recommendations provided in the experimental Empower-ICE_Fit program. | Other | Usual Care |
Primary outcome
Change in Functional Performance (A-IADL-Q-SV)
Time frame: Baseline, 8 weeks, and 12 weeks
Functional performance is evaluated using the Chinese version of the Amsterdam IADL Questionnaire-Short Version (A-IADL-Q-SV). This tool assesses the difficulties individuals experience in instrumental activities of daily living. A higher score indicates a higher level of functional performance and greater independence, representing a better outcome.
Change in Neuropsychiatric Symptoms (NPI-Q-C)
Time frame: Baseline, 8 weeks, and 12 weeks
Neuropsychiatric symptoms are evaluated using the Chinese version of the Neuropsychiatric Inventory Questionnaire (NPI-Q-C). This tool assesses 12 behavioral and psychological symptoms common in dementia. The total symptom severity score is the sum of the severity ratings for all 12 items, ranging from 0 to 36 (each item scored from 0 to 3). A higher score indicates more severe neuropsychiatric symptoms, representing a worse outcome.
Change in Social Engagement and Independence (EID-Q-C)
Time frame: Baseline, 8 weeks, and 12 weeks
Social engagement and independence are evaluated using the Chinese version of the Engagement and Independence in Dementia Questionnaire (EID-Q-C). This tool assesses the individual's level of meaningful activity and social interaction. A higher score indicates a greater level of social engagement and independence, representing a better outcome.
4 secondary outcomes
Change in Participant Quality of Life (QoL-AD)
Time frame: Baseline, 8 weeks, and 12 weeks
Change in Caregiver Quality of Life (SF-12)
Time frame: Baseline, 8 weeks, and 12 weeks
Change in Fear of Falling (FES-I)
Time frame: Baseline, 8 weeks, and 12 weeks
Change in Caregiver Burden (ZBI)
Time frame: Baseline, 8 weeks, and 12 weeks
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 22 Oct 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.
Yanan HUANG principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing empowerment-based Intrinsic capacity-Environment Fit in people with Dementia, run by The University of Hong Kong at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Oct 2026. 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 China. 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?
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 Yanan HUANG (852+64737835, yananhk@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Performance (A-IADL-Q-SV) (time frame: Baseline, 8 weeks, and 12 weeks). The study lists 3 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 22 Oct 2026.