Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473012
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Cluster RCT of Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Cluster Randomized Controlled Trial to Test the Efficacy of a Cognitive Behavioral Therapy to Support Caregivers of Older Adults in Hong Kong
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this cluster randomized controlled trial study is to compare the effectiveness of a novel psychosocial intervention based on Cognitive Behavioral Therapy lifestyle intervention and effective communication skills in caregivers of older adults in Hong Kong The main questions it aims to answer are
What is the impact of the 6-week psychosocial intervention on distress and burden among participants Participants will participate in a 6-week psychosocial intervention Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden
What is the impact of the 6-week psychosocial intervention on distress and burden among participants Participants will participate in a 6-week psychosocial intervention Researchers will compare the results between the intervention group and the active control group to see if participants in the intervention group have lower distress and burden
Detailed Description:
Proposed Study
The investigators propose a 6-week cluster randomized controlled trial to compare the effectiveness of a novel psychosocial intervention for caregivers of older adults in Hong Kong The intervention is based on Cognitive Behavioral Therapy lifestyle intervention and effective communication skills
Cluster Randomization
The research team will perform cluster randomization using statistical software and notify the district-based caregiver support units of their group allocations Randomisation will be first stratified by SES of district-based caregiver support units then using random permuted blocks via an online computer randomisation system from an independent clinical trials unit District-based caregiver support units will be randomised into an intervention or control group
Objectives
The primary objective of this study is to reduce carers depressive symptoms and anxiety through the implementation of a CBT-guided intervention that includes symptom management stress management and coping skills training The secondary objective of this study is to improve carers self-efficacy for stress management by providing them with the necessary skills and strategies from the CBT-guided intervention
Recruitment and Inclusion Criteria
A total of 250 caregivers from elderly community service 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 Participants must report significant insufficiency in self-efficacy a score 50 using the Caregiver Self-Efficacy Scale CSES-8 or 7 low level of caregiving preparedness a score 2 using the Preparedness for Caregiving Scale CPS 8 Additionally participants must report moderate risk need in the Carer Need Screening tool as well as 9 mild to moderate depressive symptoms PHQ-9 score 5-14 and 10 mild to moderate anxiety GAD-7 score 5-14 The exclusion criteria include 1 the older family member receiving government-subvented service 2 having diagnosed Alzheimers or other dementia or 3 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 Pre-implementation and post-implementation assessments as well as a 3-month follow-up evaluation 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 Need Screening 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 two 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 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 two 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 cluster randomized controlled trial to compare the effectiveness of a novel psychosocial intervention for caregivers of older adults in Hong Kong The intervention is based on Cognitive Behavioral Therapy lifestyle intervention and effective communication skills
Cluster Randomization
The research team will perform cluster randomization using statistical software and notify the district-based caregiver support units of their group allocations Randomisation will be first stratified by SES of district-based caregiver support units then using random permuted blocks via an online computer randomisation system from an independent clinical trials unit District-based caregiver support units will be randomised into an intervention or control group
Objectives
The primary objective of this study is to reduce carers depressive symptoms and anxiety through the implementation of a CBT-guided intervention that includes symptom management stress management and coping skills training The secondary objective of this study is to improve carers self-efficacy for stress management by providing them with the necessary skills and strategies from the CBT-guided intervention
Recruitment and Inclusion Criteria
A total of 250 caregivers from elderly community service 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 Participants must report significant insufficiency in self-efficacy a score 50 using the Caregiver Self-Efficacy Scale CSES-8 or 7 low level of caregiving preparedness a score 2 using the Preparedness for Caregiving Scale CPS 8 Additionally participants must report moderate risk need in the Carer Need Screening tool as well as 9 mild to moderate depressive symptoms PHQ-9 score 5-14 and 10 mild to moderate anxiety GAD-7 score 5-14 The exclusion criteria include 1 the older family member receiving government-subvented service 2 having diagnosed Alzheimers or other dementia or 3 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 Pre-implementation and post-implementation assessments as well as a 3-month follow-up evaluation 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 Need Screening 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 two 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 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 two 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None