Clinical trial NCT06736782: Holistic Self-Empowerment Care Intervention for Optimized Independent Living and Quality of Life: A Study Protocol
Official title: Holistic Self-Empowerment Care Intervention for Optimized Independent Living and Quality of Life: A Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long-Term Care
Caregiver Burden
Keywords: Self-Empowerment
Caregiving
Long-term Care
Hong Kong
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Christian Family Service Centre
First posted: 2024-12-17
Enrollment: 207
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* Functional decline
* Potential to benefit from reablement.

Exclusion Criteria:

* Severe cognitive impairment, those with mild impairment will be considered.
* Severe mental illness
* Terminal illness

Primary outcomes:
measure: Barthel Index
timeFrame: 12 Weeks
measure: EQ-5D-5L
timeFrame: 12 Weeks
measure: Adult Social Care Outcomes Toolkit (ASCOT)
timeFrame: 12 Weeks
measure: Self-Determination Survey
timeFrame: 12 Weeks
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Minnesota Satisfaction Questionnaire (MSQ)
timeFrame: 12 Weeks
measure: Zarit Caregiver Burden Interview (ZBI)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sau Po Centre on Ageing, HKU
Study officials:
References: