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

NCT06736782 | Recruiting

• 1 other identifier: EA240023
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-Term Care; Caregiver Burden

Keywords

Self-Empowerment; Caregiving; Long-term Care; Hong Kong

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  12 Weeks

• Self-Determination Survey

  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)

  Evaluates participants' ability to perform more complex daily tasks, such as managing finances and medication, with higher scores reflecting better functionality.

  12 Weeks

Secondary Outcomes (2)

• Minnesota Satisfaction Questionnaire (MSQ)

  12 Weeks

• Zarit Caregiver Burden Interview (ZBI)

  12 Weeks

Study Arms (2)

Self-Empowerment Care Intervention Group

EXPERIMENTAL

Participants in the experimental group will receive a 12-week intervention based on the Self-Empowerment Care model.

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.

Behavioral: Control Group

Interventions

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.

Self-Empowerment Care Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Christian Family Service Centre: collaborator

Study Sites (1)

Sau Po Centre on Ageing, HKU

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Vivian Lou, PhD

CONTACT

+852 3917 4835; wlou@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)