NCT07889635 · NOT YET RECRUITING

The Effects of an Empower_ICE-Fit Program in PLwD Living at Home

This study tests a program that matches the home to what a person with mild dementia can still do. Researchers assess the home, then offer tailored home modification advice. They measure daily functioning and quality of life for both patients and family caregivers. It is not a drug trial, and the phase is not applicable.

Eligibility criteria

PLwD inclusion criteria:
1. Aged 60 years or above and living in a private residence, with no plan to relocate within the following six months.
2. A documented diagnosis of mild dementia, operationalized as a Clinical Dementia Rating global score of 1.
3. 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.
4. Able to communicate in Mandarin and able to read and write Chinese, if confirmed as required for study participation.
5. Able and willing to participate in study assessments and intervention procedures, with appropriate caregiver support.
Caregiver inclusion criteria:
1. Aged 18 years or above.
2. An unpaid primary family caregiver providing at least 20 hours of care per week.
3. Able to communicate in Mandarin and read and write Chinese.
4. Able to use a smartphone or tablet for video calls and digital study materials.
5. Willing to participate in the intervention sessions and assessments and provide separate written informed consent.
PLwD exclusion criteria:
1. 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.
2. Current participation in another structured home-environment modification or non-pharmacological behavioural intervention.
3. Severe uncorrected hearing or visual impairment that prevents participation despite reasonable accommodation.
4. A health condition that makes participation in the assessments or intervention unsafe.
Caregiver exclusion criteria:
1. Unable or unwilling to participate in the intervention sessions or assessments.
2. Significant cognitive, psychiatric, communication or sensory difficulty preventing informed participation.
3. 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-10-22

View full record on ClinicalTrials.gov

All APOE4 clinical trials