Long-Term CareNCT06736782
Holistic Self-Empowerment Care Intervention for Optimized Independent Living and Quality of Life: A Study Protocol
A study testing Self-Empowerment Care Intervention Group in people with Long-Term Care and Caregiver Burden, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This protocol describes a pilot study evaluating the effectiveness of the Self-Empowerment Care Model in promoting independence and quality of life among frail older adults in Hong Kong. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Long-Term Care, Caregiver Burden
- What is being tested?
- Self-Empowerment Care Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 1 Mar 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Functional decline
- Potential to benefit from reablement.
Who cannot join
- Severe cognitive impairment, those with mild impairment will be considered.
- Severe mental illness
- Terminal illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Sau Po Centre on Ageing, HKU
Hong Kong
Vivian Lou, PhD, +852 3917 4835, wlou@hku.hk
About this study
This protocol describes a pilot study evaluating the effectiveness of the Self-Empowerment Care Model in promoting independence and quality of life among frail older adults in Hong Kong. Rooted in Nordic re-enablement principles and refined in Japan, the intervention adopts a holistic approach that focuses on hydration, exercise, diet, and defecation care. This 12-week intervention will be tested across three care settings-residential, day care, and home care. The study uses a quasi-experimental design involving 60 participants, aiming to compare outcomes of the intervention group with a control group receiving standard care. The study also assesses its impact on caregivers' burden and job satisfaction.
Read the detailed description
Introduction:
As populations age, maintaining independence in activities of daily living (ADLs) becomes essential to enhance quality of life (QOL) and reduce caregiver burden. However, traditional custodial practices often exacerbate functional decline among older adults. The Self-Empowerment Care model emphasizes enhancing independence through tailored interventions addressing physical, social, and cultural needs. Despite its successful implementation in Japan and Taiwan, its application in Hong Kong remains unexplored.
Objectives:
Evaluate the feasibility, acceptability, and effectiveness of the Self-Empowerment Care model in improving ADLs and QOL for frail older adults.
Assess the impact on caregivers, including reduced burden and enhanced job satisfaction.
Identify factors affecting the sustainability of the intervention.
Methods:
Study Design: Quasi-experimental with a 1:1 allocation ratio.
Participants:
Older adults aged ≥65 years with functional decline. Informal and formal caregivers participating voluntarily. Exclusion: severe cognitive or mental illness, terminal illness. Sample Size: 60 older adults (30 per group), plus caregivers.
Intervention: Four components:
- Hydration: Promote daily water intake of 2000 mL.
- Exercise: Sequential activities tailored by physiotherapists.
- Defecation Care: Personalized interventions based on habits.
- Dietary Support: Nutritionally balanced meals and independent eating. Control Group: Standard care without structured interventions.
Data Collection:
Quantitative: ADLs (Barthel Index), QOL (EQ-5D-5L), caregiver burden (Zarit Interview), and caregiver satisfaction (Minnesota Satisfaction Questionnaire).
Qualitative: Focus groups with caregivers to explore their experiences. Timeline: Pre- and post-intervention assessments with a follow-up focus group. Analysis A mixed-method approach will be used. Quantitative data will undergo statistical analyses (e.g., linear mixed-effects models) to compare outcomes between intervention and control groups. Qualitative data will be analyzed thematically.
Ethics and Dissemination:
Approved by the Human Research Ethics Committee of the University of Hong Kong, the study prioritizes participants' dignity and autonomy. Results will be disseminated through academic publications and shared with policymakers to inform eldercare practices.
Significance:
This study is among the first in Hong Kong to implement and evaluate the Self-Empowerment Care model. It aims to provide empirical evidence for integrating holistic eldercare models into routine practices, with the potential to benefit both aging individuals and caregivers.
- Conditions
- Long-Term Care, Caregiver Burden
- Being tested
- Self-Empowerment Care Intervention Group, Control Group
- Keywords
- Self-Empowerment, Caregiving, Long-term Care, Hong Kong
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Empowerment Care Intervention GroupBehavioural
The intervention emphasizes four key principles: hydration, exercise, dietary support, and defecation care. Each component is designed to address fundamental needs and promote independence in activities of daily living (ADLs).
Individualized care plans will be developed in collaboration with healthcare professionals and caregivers to ensure alignment with participants' functional capabilities and personal goals.
Control GroupBehavioural
Standard caregiving practices without emphasis on structured hydration, exercise, or dietary programs.
General assistance with ADLs as per existing care routines in the respective facilities.
| Study group | Role | What they receive |
|---|---|---|
| Self-Empowerment Care Intervention Group | Experimental | Participants in the experimental group will receive a 12-week intervention based on the Self-Empowerment Care model. Receives: Behavioral: Self-Empowerment Care Intervention Group |
| Control Group | Active comparator | Participants in the control group will receive usual care provided in their respective care settings. This includes routine assistance with daily activities, basic medical support, and general health monitoring without the structured interventions specific to the Self-Empowerment Care model. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
Evaluates participants' ability to perform basic activities of daily living (ADLs) independently. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: 12 Weeks
EQ-5D-5L
A standardized instrument measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 12 Weeks
Adult Social Care Outcomes Toolkit (ASCOT)
Assesses quality of life in the context of social care, with higher scores indicating better social care outcomes.
Measured: 12 Weeks
Self-Determination Survey
Measures participants' autonomy and motivation in managing their own care, capturing changes in self-determination over time.
Measured: 12 Weeks
Instrumental Activities of Daily Living (IADL)
Evaluates participants' ability to perform more complex daily tasks, such as managing finances and medication, with higher scores reflecting better functionality.
Measured: 12 Weeks
Secondary outcomes (2)
Minnesota Satisfaction Questionnaire (MSQ)
Measures job satisfaction among formal caregivers, with higher scores indicating greater satisfaction in their caregiving roles.
Measured: 12 Weeks
Zarit Caregiver Burden Interview (ZBI)
Evaluates the emotional, physical, and financial burden experienced by informal caregivers, with higher scores indicating greater burden.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Term CareStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A multi-site quasi-experimental study is planned to evaluate the feasibility, acceptability, and effectiveness of a Self-Empowerment Care model tailored for frail older adults in Hong Kong. Participants will be allocated into one intervention group and one control group, with the intervention group receiving a 12-week program focused on hydration, exercise, dietary support, and defecation care. This model, rooted in Nordic re-enablement principles and adapted in Japan, aims to enhance participants' independence in activities of daily living (ADLs) and quality of life (QOL).
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Family Service Centre
- Responsible party
- Principal investigator, Prof. Vivian W.Q. Lou, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736782
- Sponsor's protocol ID
- EA240023
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Self-Empowerment Care Intervention for Optimized Independent Living and Quality of Life: A Study Protocol
- ClinicalTrials.gov ID
- NCT06736782
- Acronym / sponsor ID
- EA240023
- Conditions
- Long-Term Care, Caregiver Burden
- Keywords
- Self-Empowerment, Caregiving, Long-term Care, Hong Kong
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Christian Family Service Centre
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 17 Dec 2024 (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.
This protocol describes a pilot study evaluating the effectiveness of the Self-Empowerment Care Model in promoting independence and quality of life among frail older adults in Hong Kong. Rooted in Nordic re-enablement principles and refined in Japan, the intervention adopts a holistic approach that focuses on hydration, exercise, diet, and defecation care. This 12-week intervention will be tested across three care settings-residential, day care, and home care. The study uses a quasi-experimental design involving 60 participants, aiming to compare outcomes of the intervention group with a control group receiving standard care. The study also assesses its impact on caregivers' burden and job satisfaction.
Detailed description
Introduction:
As populations age, maintaining independence in activities of daily living (ADLs) becomes essential to enhance quality of life (QOL) and reduce caregiver burden. However, traditional custodial practices often exacerbate functional decline among older adults. The Self-Empowerment Care model emphasizes enhancing independence through tailored interventions addressing physical, social, and cultural needs. Despite its successful implementation in Japan and Taiwan, its application in Hong Kong remains unexplored.
Objectives:
Evaluate the feasibility, acceptability, and effectiveness of the Self-Empowerment Care model in improving ADLs and QOL for frail older adults.
Assess the impact on caregivers, including reduced burden and enhanced job satisfaction.
Identify factors affecting the sustainability of the intervention.
Methods:
Study Design: Quasi-experimental with a 1:1 allocation ratio.
Participants:
Older adults aged ≥65 years with functional decline. Informal and formal caregivers participating voluntarily. Exclusion: severe cognitive or mental illness, terminal illness. Sample Size: 60 older adults (30 per group), plus caregivers.
Intervention: Four components:
- Hydration: Promote daily water intake of 2000 mL.
- Exercise: Sequential activities tailored by physiotherapists.
- Defecation Care: Personalized interventions based on habits.
- Dietary Support: Nutritionally balanced meals and independent eating. Control Group: Standard care without structured interventions.
Data Collection:
Quantitative: ADLs (Barthel Index), QOL (EQ-5D-5L), caregiver burden (Zarit Interview), and caregiver satisfaction (Minnesota Satisfaction Questionnaire).
Qualitative: Focus groups with caregivers to explore their experiences. Timeline: Pre- and post-intervention assessments with a follow-up focus group. Analysis A mixed-method approach will be used. Quantitative data will undergo statistical analyses (e.g., linear mixed-effects models) to compare outcomes between intervention and control groups. Qualitative data will be analyzed thematically.
Ethics and Dissemination:
Approved by the Human Research Ethics Committee of the University of Hong Kong, the study prioritizes participants' dignity and autonomy. Results will be disseminated through academic publications and shared with policymakers to inform eldercare practices.
Significance:
This study is among the first in Hong Kong to implement and evaluate the Self-Empowerment Care model. It aims to provide empirical evidence for integrating holistic eldercare models into routine practices, with the potential to benefit both aging individuals and caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-site quasi-experimental study is planned to evaluate the feasibility, acceptability, and effectiveness of a Self-Empowerment Care model tailored for frail older adults in Hong Kong. Participants will be allocated into one intervention group and one control group, with the intervention group receiving a 12-week program focused on hydration, exercise, dietary support, and defecation care. This model, rooted in Nordic re-enablement principles and adapted in Japan, aims to enhance participants' independence in activities of daily living (ADLs) and quality of life (QOL).
| Arm | Type | Receives |
|---|---|---|
| Self-Empowerment Care Intervention Group | Experimental | Behavioral: Self-Empowerment Care Intervention GroupParticipants in the experimental group will receive a 12-week intervention based on the Self-Empowerment Care model. |
| Control Group | Active comparator | Behavioral: Control GroupParticipants in the control group will receive usual care provided in their respective care settings. This includes routine assistance with daily activities, basic medical support, and general health monitoring without the structured interventions specific to the Self-Empowerment Care model. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or older
- Functional decline
- Potential to benefit from reablement.
Key exclusion criteria (3 listed)
- Severe cognitive impairment, those with mild impairment will be considered.
- Severe mental illness
- Terminal illness
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 |
|---|---|---|
| Self-Empowerment Care Intervention GroupThe intervention emphasizes four key principles: hydration, exercise, dietary support, and defecation care. Each component is designed to address fundamental needs and promote independence in activities of daily living (ADLs). Individualized care plans will be developed in collaboration with healthcare professionals and caregivers to ensure alignment with participants' functional capabilities and personal goals. | Behavioural | Self-Empowerment Care Intervention Group |
| Control GroupStandard caregiving practices without emphasis on structured hydration, exercise, or dietary programs. General assistance with ADLs as per existing care routines in the respective facilities. | Behavioural | Control Group |
Primary outcome
Barthel Index
Time frame: 12 Weeks
Evaluates participants' ability to perform basic activities of daily living (ADLs) independently. Scores range from 0 to 100, with higher scores indicating greater independence.
EQ-5D-5L
Time frame: 12 Weeks
A standardized instrument measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Adult Social Care Outcomes Toolkit (ASCOT)
Time frame: 12 Weeks
Assesses quality of life in the context of social care, with higher scores indicating better social care outcomes.
Self-Determination Survey
Time frame: 12 Weeks
Measures participants' autonomy and motivation in managing their own care, capturing changes in self-determination over time.
Instrumental Activities of Daily Living (IADL)
Time frame: 12 Weeks
Evaluates participants' ability to perform more complex daily tasks, such as managing finances and medication, with higher scores reflecting better functionality.
2 secondary outcomes
Minnesota Satisfaction Questionnaire (MSQ)
Time frame: 12 Weeks
Zarit Caregiver Burden Interview (ZBI)
Time frame: 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 17 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Empowerment Care Intervention Group in people with Long-Term Care and Caregiver Burden, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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 Vivian Lou, PhD (+852 3917 4835, wlou@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (time frame: 12 Weeks). 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 17 Dec 2024.