DementiaNCT03308032
Self-Directed Online Training for Chinese Caregivers
A study testing Intervention in people with Dementia and Alzheimer Disease, run by Environment and Health Group, Inc..
Trial summary
The proposed project seeks to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ethnic Chinese Caregiver
Who cannot join
- Not Chinese or Caregiver
About this study
The proposed project seeks to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia.
Read the detailed description
The objective of this Phase II application is to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia. While online dementia caregiver interventions are advantageous in reaching broad audiences, these individuals face significant challenges in engaging the target audience and keeping them engaged throughout the intervention program. The proposed online SDL skill training intervention addresses these challenges with a comprehensive engagement design to ensure retention and effective learning in the training program.
All Phase I Study Aims have been successfully completed. The prototype provides preliminary evidence that an SDL training intervention is able to successfully engage ethnic Chinese caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase II study will further develop the prototype into a fully-functioning online SDL skill training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized control trial. In Specific Aim 1, the research team will develop additional multi-lingual training video clips to complete the training program, and make them available for Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural backgrounds. In Specific Aim 2, the research team will develop software that enables and integrates all engagement design functionalities. In Specific Aim 3, the research team will conduct a randomized controlled trial to evaluate the effectiveness of the SDL training intervention based on a comprehensive engagement design (intervention arm) compared to one that does not rely on a comprehensive engagement design (control arm).
Evidence of the effectiveness of the SDL intervention will contribute to the larger information and communication technology field, increasing the public's understanding and basic knowledge of effective engagement in the rapidly growing field of online health interventions. The comprehensive engagement approach developed through this research could be transferred to other ethnic minority groups facing dementia caregiving challenges, as well as other populations facing challenges related to the management of other chronic conditions.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Intervention, Control
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
SDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating
ControlBehavioural
Participants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons. For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both Receives: Behavioral: Intervention |
| Control | Active comparator | Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course.
Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons (see below). For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress Level
Will be assessed using the 10 point Perceived Stress Scale
Measured: At Week 1 and at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Sep 2016
- Primary completion5 Mar 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Environment and Health Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308032
- Sponsor's protocol ID
- NIH 1R43HL115924-01
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Directed Online Training for Chinese Caregivers
- ClinicalTrials.gov ID
- NCT03308032
- Acronym / sponsor ID
- NIH 1R43HL115924-01
- Conditions
- Dementia, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Environment and Health Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 5 Mar 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 12 Oct 2017 (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.
The proposed project seeks to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia.
Detailed description
The objective of this Phase II application is to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia. While online dementia caregiver interventions are advantageous in reaching broad audiences, these individuals face significant challenges in engaging the target audience and keeping them engaged throughout the intervention program. The proposed online SDL skill training intervention addresses these challenges with a comprehensive engagement design to ensure retention and effective learning in the training program.
All Phase I Study Aims have been successfully completed. The prototype provides preliminary evidence that an SDL training intervention is able to successfully engage ethnic Chinese caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase II study will further develop the prototype into a fully-functioning online SDL skill training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized control trial. In Specific Aim 1, the research team will develop additional multi-lingual training video clips to complete the training program, and make them available for Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural backgrounds. In Specific Aim 2, the research team will develop software that enables and integrates all engagement design functionalities. In Specific Aim 3, the research team will conduct a randomized controlled trial to evaluate the effectiveness of the SDL training intervention based on a comprehensive engagement design (intervention arm) compared to one that does not rely on a comprehensive engagement design (control arm).
Evidence of the effectiveness of the SDL intervention will contribute to the larger information and communication technology field, increasing the public's understanding and basic knowledge of effective engagement in the rapidly growing field of online health interventions. The comprehensive engagement approach developed through this research could be transferred to other ethnic minority groups facing dementia caregiving challenges, as well as other populations facing challenges related to the management of other chronic conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionParticipants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons. For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both |
| Control | Active comparator | Behavioral: ControlParticipants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons (see below). For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ethnic Chinese Caregiver
Key exclusion criteria (1 listed)
- Not Chinese or Caregiver
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 |
|---|---|---|
| InterventionSDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating | Behavioural | Intervention |
| ControlParticipants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content. | Behavioural | Control |
Primary outcome
Change in Stress Level
Time frame: At Week 1 and at Week 12
Will be assessed using the 10 point Perceived Stress Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Dementia and Alzheimer Disease, run by Environment and Health Group, Inc..
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: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in Stress Level (time frame: At Week 1 and at Week 12). 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 12 Oct 2017.