Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07889635

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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 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.

Official title: The Effects of an Empowerment-based Intrinsic Capacity-Environment Fit Program in People With Dementia Living at Home

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

304

Start Date

2026-10-20

Completion Date

2028-03-01

Last Updated

2026-10-22

Healthy Volunteers

Conditions

Dementia

Interventions

BEHAVIORAL

empowerment-based Intrinsic capacity-Environment Fit

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.

OTHER

Usual Care Group

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.

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.

Locations (2)

Shandong Medical and Pharmaceutical University Hospital

Binzhou, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China