An interventional study of empowerment-based Intrinsic capacity-Environment Fit and Usual Care Group in Dementia, sponsored by The University of Hong Kong. Not yet recruiting at 2 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
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.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's planned enrollment of 304 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
PLwD inclusion criteria:
Caregiver inclusion criteria:
PLwD exclusion criteria：
Caregiver exclusion criteria：
Home-related exclusion：
(1) The residence contains immediate major structural, electrical or fire hazards outside the scope of the non-structural intervention.
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.
Behavioral: empowerment-based Intrinsic capacity-Environment Fit
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.
Other: Usual Care Group
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.
Also known as: Empower-ICE_Fit Program
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks, and 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks, and 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2028, 15 months later.
Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 15 months is below that.
Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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