Menu
Recruiting NCT06736782

Holistic Self-Empowerment Care Intervention for Optimized Independent Living and Quality of Life: A Study Protocol

No phase Interventional Long-Term Care Caregiver Burden

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Empowerment Care Intervention Group, Control Group.
Who it may be relevant to
Registry conditions: Long-Term Care, Caregiver Burden. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Self-Empowerment Care Intervention Group
    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.
  • Behavioral Control Group
    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.

Primary outcome measures

  • Barthel Index [Time frame: 12 Weeks]
  • EQ-5D-5L [Time frame: 12 Weeks]
  • Adult Social Care Outcomes Toolkit (ASCOT) [Time frame: 12 Weeks]
  • Self-Determination Survey [Time frame: 12 Weeks]
  • Instrumental Activities of Daily Living (IADL) [Time frame: 12 Weeks]
Secondary outcome measures (2)
  • Minnesota Satisfaction Questionnaire (MSQ) [Time frame: 12 Weeks]
  • Zarit Caregiver Burden Interview (ZBI) [Time frame: 12 Weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • Sau Po Centre on Ageing, HKU — Hong Kong

Identifiers

NCT: NCT06736782 · EA240023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗