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

December 12, 2024 updated by: Prof. Vivian W.Q. Lou, The University of Hong Kong
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vivian Lou, PhD
  • Phone Number: +852 3917 4835
  • Email: wlou@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Sau Po Centre on Ageing, HKU
        • Contact:
          • Vivian Lou, PhD
          • Phone Number: +852 3917 4835
          • Email: wlou@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Empowerment Care Intervention Group
Participants in the experimental group will receive a 12-week intervention based on the Self-Empowerment Care model.
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.
Active Comparator: Control Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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.
12 Weeks
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.
12 Weeks
Self-Determination Survey
Time Frame: 12 Weeks
Measures participants' autonomy and motivation in managing their own care, capturing changes in self-determination over time.
12 Weeks
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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Satisfaction Questionnaire (MSQ)
Time Frame: 12 Weeks
Measures job satisfaction among formal caregivers, with higher scores indicating greater satisfaction in their caregiving roles.
12 Weeks
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Christian Family Service Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA240023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caregiver Burden

Clinical Trials on Self-Empowerment Care Intervention Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe