StokeNCT06771557
Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers
A study testing 656 Online Platform in people with Stoke and Dementia, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
This study aimed to assess the efficacy of a new online platform, 656 Online Platform, in Hong Kong in reducing caregiver stress and enhancing caregiver preparedness and competence of caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoke, Dementia, Fall and Fractures Prevention
- What is being tested?
- 656 Online Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers: Longitudinal Open-trial Study
This study aimed to assess the efficacy of a new online platform, 656 Online Platform, in Hong Kong in reducing caregiver stress and enhancing caregiver preparedness and competence of 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.
Read the 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.
- Conditions
- Stoke, Dementia, Fall and Fractures Prevention
- Being tested
- 656 Online Platform
- Keywords
- Online Platform, Caregivers, Caregiver stress
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
656 Online PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Users of the 656 Online Platform | Experimental | 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. Receives: Other: 656 Online Platform |
| Non-users of the 656 Online Platform | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Caregiver stress
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.
Measured: From the baseline survey to the second follow-up survey at 15 months
Preparedness for caregiving
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.
Measured: From the baseline survey to the second follow-up survey at 15 months
Caregiver competence
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.
Measured: From the baseline survey to the second follow-up survey at 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Dec 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- City University of Hong Kong
- Responsible party
- Principal investigator, Dr Wendy Zhang Wen, Hong Kong Metropolitan University
- Investigators
- Yuen Ha WONG, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771557
- Sponsor's protocol ID
- 1-2021-39-E
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The privacy and personal information of the respondents are highly valued and strictly protected.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usage and Efficacy of the 656 Online Platform for Reducing Caregiver Stress in Chinese Caregivers: Longitudinal Open-trial Study
- ClinicalTrials.gov ID
- NCT06771557
- Acronym / sponsor ID
- 1-2021-39-E
- Conditions
- Stoke, Dementia, Fall and Fractures Prevention
- Keywords
- Online Platform, Caregivers, Caregiver stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- City University of Hong Kong
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the efficacy of a new online platform, 656 Online Platform, in Hong Kong in reducing caregiver stress and enhancing caregiver preparedness and competence of 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Users of the 656 Online Platform | Experimental | Other: 656 Online PlatformThe 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. |
| Non-users of the 656 Online Platform | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 656 Online PlatformThe 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. | Other | Users of the 656 Online Platform |
Primary outcome
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.
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.
Caregiver competence
Time frame: From the baseline survey to the second follow-up survey at 15 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No. The privacy and personal information of the respondents are highly valued and strictly protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuen Ha WONG principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 656 Online Platform in people with Stoke and Dementia, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver stress (time frame: From the baseline survey to the second follow-up survey at 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.