Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604481
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
An Online Ecoaching RCT Intervention for Carers Enhancing Wellbeing and Resilience Through Self-Help Strategies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial to Test the Efficacy of Online Ecoaching to Support Caregivers of Older Adults in Hong Kong Enhancing Carers Wellbeing and Resilience
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Alzheimers 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 Pearsons 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 280 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
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 Alzheimers 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 Pearsons 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 280 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None