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NCT Number: NCT06736782

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Empowerment Care Intervention Group

Behavioral

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 Group

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Self-Determination Survey

    Time frame: 12 Weeks

    Measures participants' autonomy and motivation in managing their own care, capturing changes in self-determination over time.

  5. 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.

Secondary outcomes

  1. Minnesota Satisfaction Questionnaire (MSQ)

    Time frame: 12 Weeks

    Measures job satisfaction among formal caregivers, with higher scores indicating greater satisfaction in their caregiving roles.

  2. Zarit Caregiver Burden Interview (ZBI)

    Time frame: 12 Weeks

    Evaluates the emotional, physical, and financial burden experienced by informal caregivers, with higher scores indicating greater burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Vivian Lou, PhD

CONTACT

[email protected]

+852 3917 4835

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Christian Family Service Centre

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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