- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06771557
Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers
Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers: Longitudinal Open-trial Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The informal caregivers of older adults with serious health problems, especially for stroke, dementia, and fracture, are facing numerous caregiving stress. The online platform can be a cost-effective way to support caregivers and reduce their caregiving stress.
A new online platform, the 655 Online Platform, was developed by St. James Settlement in Hong Kong, to provide caregivers with appropriate information and support, attempting to reduce their pressure. Therefore, this study was launched to evaluate the efficacy of a new online platform in reducing caregiver stress and enhancing caregiver preparedness and competence in caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and examine user satisfaction and engagement.
A longitudinal open-trial study design was applied (N=287) with outcome measures administered at baseline, 3-month follow-up, and 15-month follow-up. Primary outcomes included changes in caregiver stress, caregiver preparedness, and competence. The user profile was explored by comparing the characteristics of participants in user group and non-user group. User satisfaction and engagement were also reported.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong, 999077
- Hong Kong Metropolitan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Family caregivers who are Chinese citizens aged 18 or above and provide care for elderly individuals aged 65 or above diagnosed with stroke, dementia, or fall-related fractures
Exclusion Criteria:
- Family caregivers who have been diagnosed with severe mental or physical illness or have impairments in cognitive function, such as comprehension, memory, observation, and other related abilities
Study Plan
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: Users of the 656 Online Platform
The experimental arm includes caregivers of the elderly with three targeted disorders (stroke, dementia, and fall-related fractures) who used the 656 Online Platform.
The 656 Platform provides valuable information regarding three common ailments among the elderly, namely stroke, dementia, and fall-related fractures.
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The 656 Platform provides valuable information regarding three common ailments among the elderly, namely stroke, dementia, and fall-related fractures.
Serving as an online platform, the 656 Platform incorporates a Chatbot feature that facilitates connections between local caregivers, social workers, and community members to various services.
Serving as an online platform, the 656 Platform incorporates an AI Chatbot and a Live Chat feature that facilitates connections between local caregivers, social workers, and community members to various services.
Apart from this, the 656 Platform offers several features that enhance its functionality and user experience, including problem-based elderly resource database, interim care solutions, exchange forum, data analytics and research, and professional knowledge and resources.
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|
No Intervention: Non-users of the 656 Online Platform
This arm includes caregivers of the elderly with three targeted disorders (stroke, dementia, and fall-related fractures) who did not use the 656 Online Platform.
The 656 Platform provides valuable information regarding three common ailments among the elderly, namely stroke, dementia, and fall-related fractures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver stress
Time Frame: From the baseline survey to the second follow-up survey at 15 months
|
Caregiver stress was measured by Modified Caregiver Strain Index (C-M-CSI).
It consists of 13 items with a total score ranging from 0 to 26.
Each item is rated by a score of 0 (no), 1 (yes, sometimes) or 2 (yes, always).
A higher score suggests a higher amount of strain felt by caregivers.
The C-M-CSI demonstrated good psychometric properties in the Chinese population.
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From the baseline survey to the second follow-up survey at 15 months
|
|
Preparedness for caregiving
Time Frame: From the baseline survey to the second follow-up survey at 15 months
|
Preparedness for caregiving was measured by the Chinese version of Preparedness for Caregiving Scale.
The scale consists of 8 items that ask careers how well prepared they believe they are for multiple domains of caregiving.
Each item is rated by a five-point Likert scale from 0 (not at all prepared) to 4 (very well prepared) with a total score from 0 to 32.
The scale showed good reliability and validity in the Chinese population.
|
From the baseline survey to the second follow-up survey at 15 months
|
|
Caregiver competence
Time Frame: From the baseline survey to the second follow-up survey at 15 months
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Caregiver competence was measured by the Chinese version of Caregiver Competence Scale (CCS-C).The scale includes 4 items to assess the sufficiency of a caregiver's performance as administered by the caregiver.
A higher score indicates a better sense of competence.
The CCS-C demonstrated good psychometric properties in the Chinese caregivers.
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From the baseline survey to the second follow-up survey at 15 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yuen Ha WONG, Hong Kong Metropolitan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2021-39-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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