An Online Ecoaching RCT Intervention for Carers: Enhancing Wellbeing and Resilience Through Self-Help Strategies

Randomized Controlled Trial to Test the Efficacy of Online Ecoaching to Support Caregivers of Older Adults in Hong Kong: Enhancing Carers' Wellbeing and Resilience

The goal of this three-armed, double-blind randomized controlled trial (RCT) is to compare the effectiveness of an online self-help eCoaching intervention designed for caregivers. The main questions it aims to answer are:

What is the impact of the online self-help eCoaching intervention on the well-being, depressive symptoms, and self-efficacy of participants? Researchers will compare the results between the intervention groups and the control group to see if participants in the intervention groups have lower distress, burden and higher accuracy.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Caregiver Burden; Anxiety Depression; Self Efficacy; Resilience
• Intervention / Treatment: Behavioral: eCoaching for Caregivers of Older Adults; Behavioral: eCoaching (need specific) for Caregivers of Older Adults; Behavioral: Control Intervention for Caregivers of Older Adults

Detailed Description

Proposed Study:

The investigators propose a 6-week randomized controlled trial to compare the effectiveness of a novel online self-help intervention for caregivers of older adults in Hong Kong. The intervention is based on Cognitive Behavioral Therapy, lifestyle intervention, and effective communication skills.

Randomization:

The research team will perform individual randomization using statistical software R. Randomization will be using random permuted blocks via an online computer randomization system from an independent clinical trials unit. Participants will be randomized into two intervention groups or control group.

Outcomes:

The primary objective of this study is to evaluate the effectiveness of an online self-help eCoaching intervention that incorporates symptom management, stress management, and coping skills training in promoting healthy behavior change among caregivers. Additionally, this study aims to investigate the effectiveness of the online self-help eCoaching intervention in reducing carers' depressive symptoms and anxiety. Another key objective is to enhance carers' self-efficacy for stress management and resilience by equipping them with the necessary skills and strategies provided through the eCoaching intervention.

Recruitment and Inclusion Criteria:

A total of 232 caregivers from seven district-based caregiver support units will be recruited. The inclusion criteria are as follows: 1) Participants must be adults aged 18 or above with a family member aged 60 or above requiring caregiving, providing at least 6 hours of care per week; 2) They must self-identify as a family caregiver; 3) Participants must live in Hong Kong and 4) be able to communicate with the interventionist; 5) Participation must be voluntary; 6) Additionally, participants must report mild need in the Carer multidimensional Need Assessment tool. The exclusion criteria include: 1) having diagnosed Alzheimer's or other dementia; or 2) experiencing acute health conditions that hinder caregiving support or intervention participation.

Study Procedures:

This study will consist of a 6-week intervention, with a screening process to be conducted prior to the intervention implementation. Baseline and immediately after the intervention, as well as a 3-month follow-up assessment, will be performed for statistical comparison. The participation of caregivers in tests, surveys, and interviews will not affect the quality of care they receive. No drug usage or medical treatment is involved in this study, and there are no anticipated physical or medical risks to participants. Withdrawal from the study is voluntary at any time, and will not impact participants' ongoing medical care or legal rights.

The screening process involves carers completing a standardized screening form comprising items pertaining to demographics, self-efficacy, caregiving preparedness, and willingness to join, which they will either fill out independently or have facilitated by project staff upon enrolling for membership. Carers' needs are classified into four levels: low, mild, moderate, and high.

The Carer Multidimensional Need Assessment Tool was developed and validated by the research team of the Jockey Club Carer Space Project, which was led by Professor Vivian Lou, the Director of the Sau Po Centre on Ageing at the University of Hong Kong. The research centre followed a six-step approach, based on the scale development method proposed by Hinkin (1995), to establish the Carer Need Screening Tool. These steps encompassed: (1) a literature review, (2) the formation of an expert panel, (3) a Delphi study, (4) the confirmation of an item list, (5) an item validation study, and (6) the finalization of the scale. The research team developed a 22-item screening tool, and the screening tool involves 5 domains of risk including carers' mental ill health, caregiving capacity, lack of support, carers' health challenges, and high care demands.

Data Analysis:

A MANOVA will be conducted for the continuous variables and a chi-square test will be used for the categorical variables, to compare the differences between the primary and secondary outcomes of the three groups. The associations among different variables will be investigated using Pearson's correlation analysis. The interaction Group x Time treatment effects within and between the groups (eCoaching I, eCoaching II, Control) will be tested with a factorial ANOVA with repeated measures. Differential changes in each outcome across the 3 assessment time points (T0, T1, T2) between the three treatment groups will be compared. Recruitment rate, attrition rate, and missing data will also be examined and reported. All outcome measures will be analysed based on intention-to-treat principles. Exploratory analysis will assess whether the intervention effects are mediated by caregiver self-efficacy or knowledge gain. The data will be analysed using SPSS, version 28.0. All statistical tests will be two-sided with the level of significance set at .05.

Data Storage and Privacy:

Personal data will be securely stored by the principal investigator for 5 years after the publication of the first paper, followed by 10 years for anonymized data. All information will be used for research purposes only and stored on encrypted workstations and password-protected online cloud storage.

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivian Lou, PhD; Phone Number: 3917 4835; Email: wlou@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Sau Po Center on Ageing HKU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• being an adult aged 18 or above with a family member aged 60 or above requiring caregiving, providing at least 6 hours of care per week
• self-identifying as a family caregiver
• living in Hong Kong
• able to communicate with the interventionist
• voluntary participation
• reporting mild risk need in Carer Need Screening tool

Exclusion Criteria:

• having diagnosed Alzheimer's or other dementia
• experiencing acute health conditions that hinder caregiving support or intervention participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eCoaching Group I; Online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. All content will be covered.	Behavioral: eCoaching for Caregivers of Older Adults; The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. This program is designed to operate individually on an e-platform. It consists of 6 weekly sessions, each lasting for less than 90 minutes. The content of the sessions focuses on teaching caregivers CBT techniques, lifestyle modifications to improve caregiving experiences, and effective communication strategies. In between each session, participants are assigned home practices to reinforce the skills learned further. All content will be included.
Experimental: eCoaching Group II; Online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. Content will be covered specified to the carer's specific needs.	Behavioral: eCoaching (need specific) for Caregivers of Older Adults; The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills as in eCoaching I. However, eCoaching II will include content specified to carer's specific need.
Active Comparator: Control Group; Online sessions focused on education about lifestyle and communication.	Behavioral: Control Intervention for Caregivers of Older Adults; The control group attends 6 weekly online sessions that primarily provide educational information about lifestyle factors and communication. These sessions aim to enhance the control group's knowledge and understanding of the factors that impact caregiving. Each session in the control group also lasts for 90 minutes. The focus of these activities will be on building practical caregiving skills and promoting overall well-being, rather than targeting any particular psychological or mental health-related factors directly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a self-report instrument used to assess symptoms of depression.	3 months
Carers Multidimensional Need Assessment Tool	Carers Multidimensional Need Assessment Tool 22-item. The Carers Multidimensional Need Assessment Tool is a 22-item assessment that evaluates caregivers across 5 key domains of risk:Carers' mental ill health, Caregiving capacity, Lack of support, Carers' health challenges and High care demands.	3 months
Generalised Anxiety Disorder (GAD-7)	The GAD-7 is a 7-item screening tool used to assess the severity of generalized anxiety disorder.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cantonese short version of the Zarit Burden Interview (CZBI)	Reduced burden of caregivers	3 months
Connor-Davidson Resilience Scale (CD-RISC-25)	The CD-RISC is a 25-item self-administered scale that assesses an individual's level of resilience.	3 months
Self-Care Self-Efficacy Scale (SCSES-10)	The SCSES-10 is a measurement tool used to assess an individual's self-efficacy self-care self-efficacy for chronic illness and has been tested in the Hong Kong population.	3 months
The World Health Organization Quality of Life (WHOQoL-BREF)	The WHOQOL-BREF is a 28-item instrument developed by the World Health Organization to assess an individual's quality of life across four domains: physical health, psychological health, social relationships, and environment.	3 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Vivian Lou, PhD, Sau Po Center on Ageing, HKU

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 2023-0030-001-e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected in this study will be published and submitted to academic journals to share with other researchers.
• IPD Sharing Time Frame: Between 2024 and 2026, the data will become available.
• IPD Sharing Access Criteria: Upon request from the academic journals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No