DementiaNCT06665243
Horticultural Activities Among the People with Dementia and Their Family Caregivers
A study testing Technology-enhanced horticultural activities in people with Dementia and Caregiver Stress, run by The Hong Kong Polytechnic University.
Trial summary
The goal of this study is to explore the effects of technology-enhanced horticultural activities on people with dementia (PWD) and their family caregivers. The main questions it aims to answer are: Do these activities improve cognitive function and behavioral symptoms in PWD? Do they reduce stress and depressive… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Caregiver Stress
- What is being tested?
- Technology-enhanced horticultural activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 65 or above;
- diagnosed with any type of dementia at the early to moderate stage;
- community-dwelling (i.e., non-institutionalized); and
- able to understand Cantonese and follow simple instructions.
- aged 18 years or above;
- blood or by-marriage relatives (e.g., spouses, siblings, children, and grandchildren) of a person who has been clinically diagnosed with dementia, regardless of its type;
Show all 9Show fewer
- are taking up caring responsibilities ranging from physical aid to emotional support, in the form of transportation, financial assistance, personal hygiene, and decision-making;
- providing most of the daily care and support for PWD (daily contact for at least four hours); and
- able to speak Cantonese.
Who cannot join
- being diagnosed with a mental disorder such as bipolar disorder, schizophrenia, or depression;
- taking anticonvulsants or any kind of psychotropic drugs; and
- identified with self-reported suicidal thoughts or drug abuse in the past 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Technology-Enhanced Horticultural Activities Among the People with Dementia and Their Family Caregivers
The goal of this study is to explore the effects of technology-enhanced horticultural activities on people with dementia (PWD) and their family caregivers. The main questions it aims to answer are:
- Do these activities improve cognitive function and behavioral symptoms in PWD?
- Do they reduce stress and depressive symptoms in caregivers and improve their quality of life?
Read more
The study will have two phases:
- Phase I: Conduct a pilot study with PWD in a geriatric day hospital to evaluate feasibility and initial effects.
- Phase II: Conduct a larger trial with PWD and caregivers in community settings to further assess impact.
Participants will engage in indoor horticultural activities using a smart grower, participate in training sessions, and complete assessments before and after the intervention.
Read the detailed description
Dementia is becoming a major worldwide concern as the world's population ages and the prevalence of dementia increases exponentially with age. As the disease progresses, people with dementia (PWD) exhibit different behavioral symptoms, and their cognitive function and self-care ability gradually decline. The burden of caring and the uncertainty about disease progression result in high levels of stress and negative emotions in family caregivers.
Horticultural therapy is an effective intervention that has been shown to increase the time PWD spend engaging in leisure activities and decrease the time they spend doing nothing. Importantly, horticultural therapy has demonstrated positive effects on alleviating agitation behaviors among PWD, including harmful aggressive and destructive behaviors. PWD can also benefit from improved cognitive function, psychological symptoms (e.g., stress, depression), and enhanced social interaction when participating in horticultural therapy.
However, there are limitations and constraints for PWD to participate in horticultural therapy, especially in high-density cities like Hong Kong. First, the majority of PWD and their family caregivers cannot afford to have a garden within their homes, as many developed cities suffer from limited land space, and it is common for PWD and their caregivers to live in small areas with simple furniture. Second, uncontrollable weather contributes to the difficulty in performing horticultural therapy in outdoor conditions, as plants are sensitive to weather and vulnerable to unstable conditions, especially the fickle weather in Hong Kong. Third, insufficient human resources lead to an increased chance of failure in outdoor horticultural therapy, as it requires ample manpower to look after the condition of various plants and assist PWD and their caregivers during the therapy sessions. Therefore, performing indoor technology-enhanced horticultural activities with a smart grower machine has the potential to reduce concerns about space, weather, and manpower.
The study consists of two phases. Phase I is a pilot pre-post feasibility study conducted in a geriatric day hospital setting with 30 PWD participants. It aims to assess whether indoor technology-enhanced horticultural activities improve cognitive function and behavioral symptoms in PWD. Phase II involves a larger-scale single-arm trial with 100 pairs of PWD and caregivers in community settings to evaluate the dyadic approach's impact on caregivers' stress levels and quality of life.
The intervention uses a smart grower, an indoor hydroponic system, to facilitate horticultural activities. A mobile app assists in controlling the environment and guiding participants. The program includes eight face-to-face sessions with various cognitive and sensory activities.
Primary outcomes for PWD include engagement, cognitive functioning, and challenging behaviors. Caregivers' outcomes focus on positive caregiving experiences, perceived stress, quality of life, and depressive symptoms. Feasibility is assessed through recruitment, attendance, completion, and retention rates. Evaluations will be conducted at baseline (0 weeks) and post-intervention (8 weeks).
- Conditions
- Dementia, Caregiver Stress
- Being tested
- Technology-enhanced horticultural activities
- Keywords
- horticultural therapy, horticultural activities, people with dementia, family caregivers, informal caregivers, technology-enhanced horticultural activities
- 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.
Technology-enhanced horticultural activitiesBehavioural
The indoor technology-enhanced horticultural activities will be delivered to people with dementia and their family caregivers through a smart grower. The smart grower is a hydroponic indoor grower that creates a controllable environment with auto optimization for growing healthy plants, fresh vegetables, herbs, and fruits. A mobile app will be connected to the grower for controlling the growing environment (e.g., lighting, watering), tracking the progress of the plants, and guiding the older people with dementia and their family caregivers in conducting the horticultural activities. The program will consist of eight face-to-face (F-T-F) horticultural activity training sessions for groups of 6-8 participants. The indoor program contains various horticultural, cognitive, and multisensory stimulation activities, such as asking PWD and family caregivers to record the sense of touch and odor when caring for the plants and to observe the various changes in the plants using the smart grower.
| Study group | Role | What they receive |
|---|---|---|
| Technology-enhanced horticultural activities | Experimental | Not described Receives: Behavioral: Technology-enhanced horticultural activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
PWD Outcome: Cognitive Functioning
The MoCA-5-min will assess participants' cognitive function (Wong et al., 2015). It covers four domains: attention, executive function/language, orientation, and memory. The MoCA-5-min is highly correlated with the MoCA (r = 0.87) and has excellent test-retest reliability (ICC = 0.89). Trained nursing students will conduct the MoCA-5-min assessments.
Measured: 8 Weeks
PWD Outcome: Engagement
The Engagement of a Person with Dementia Scale (EPWDS) assesses behavioral and emotional engagement in individuals with dementia during psychosocial activities (Jones et al., 2018). Based on the Observational Method of Engagement (Cohen-Mansfield et al., 2009), it evaluates five areas: affective, visual, verbal, behavioral, and social engagement. Each area includes two items-one for positive engagement and one for disengagement-resulting in 10 items total. Negatively phrased items are reverse scored, with total scores ranging from 10 to 50, where higher scores indicate greater positive engagement. The EPWDS has excellent reliability, with an internal consistency of 0.94 and a test-retest reliability of r = 0.95 (Jones et al., 2018).
In this study, two trained nursing students will administer the EPWDS through direct observations and field notes. Inter-rater reliability will be calculated to ensure consistent assessments. Observations will last for 10 minutes and occur at T0 and T1.
Measured: 8 Weeks
PWD Outcome: Challenging Behaviors
The Challenging Behaviors Subscale of the Dementia Coding System (DeCS) will measure challenging behaviors in BPSD during the intervention (Hillebrand et al., 2023). The DeCS uses a systematic time-sampling approach, observing individuals with dementia at specific intervals. The subscale includes 18 behaviors (e.g., apathetic, tense posture, runs away) recorded on a dichotomous scale, where 0 indicates not observed and 1 indicates observed. A higher score indicates more challenging behaviors. The subscale's internal consistency is 0.71, and the test-retest reliability is ICC = 0.92 (Hillebrand et al., 2023). Two trained nursing students will conduct observations and take field notes using the DeCS. Inter-rater reliability will be calculated to ensure consistency. Observations will be conducted over five four-minute intervals at T0 and T1.
Measured: 8 Weeks
PWD Outcome: Challenging Behaviors
Challenging behaviors of the PWD will be measured by the Chinese version of the Neuropsychiatric Inventory-Questionnaire (NPI-Q) (Wong et al., 2014), administered by caregivers. It evaluates the frequency, severity, and caregiver distress of 12 neuropsychiatric symptoms using a 5-point rating scale. The NPI-Q has acceptable psychometric properties, including a high internal consistency (α = 0.76) and test-retest reliability (0.99).
Measured: 8 Weeks
Caregivers' Outcome: Positive Caregiving Experience
The Chinese version of the Positive Aspect of Caregiving scale (PAC) (Lou et al., 2015) will measure participants' positive caregiving experience. The PAC scale demonstrates acceptable internal consistency (α = 0.85) among family caregivers of PWD in Hong Kong. Higher scores indicate more positive self-perceptions of caregiving.
Measured: 8 Weeks
Caregivers' Outcome: Perceived Stress Level
The Chinese version of the Perceived Stress Scale (PSS) will measure participants' perceived stress (Leung et al., 2010). The PSS contains 10 items rated on a 5-point Likert scale from 0 (never) to 4 (very often). It has acceptable psychometric properties, including internal consistency (α = 0.85) and test-retest reliability (0.85) (Chu \& Kao, 2005; Leung et al., 2010).
Measured: 8 Weeks
Caregivers' Outcome: Quality of Life
The WHOQOL-OLD BREF (HK) will assess participants' quality of life (QOL) (Leung et al., 2005). It comprises 28 items, each rated on a 5-point Likert scale from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating better QOL. The internal consistency of the Hong Kong Chinese version of the WHOQOL is satisfactory, with Cronbach's alpha ranging from 0.73 in the environment domain to 0.83 in the psychological domain, and a test-retest reliability coefficient of 0.83.
Measured: 8 Weeks
Caregivers' Outcomes: Depressive Symptoms
The Chinese version of the Center for Epidemiological Studies Depression scale (CESDS) (Chin et al., 2015) will measure depression. It is a self-reported measure containing 20 items (Radloff, 1977). The CESD has acceptable psychometric properties, including test-retest reliability (0.91) and internal consistency for general depression (α = 0.86).
Measured: 8 Weeks
Secondary outcomes (4)
Feasibility Outcome: Recruitment Rate
The ratio of participants enrolled to the total number approached.
Measured: 8 Weeks
Feasibility Outcome: Attendance Rate
The average number of sessions attended by participants relative to the total sessions offered.
Measured: 8 Weeks
Feasibility Outcome: Completion Rate
The proportion of participants who complete at least 80% of required assessments and interventions compared to those initially enrolled.
Measured: 8 Weeks
Feasibility Outcome: Retention Rate
The percentage of participants who remain in the study from T0 through T1.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick KOR Pui Kin, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665243
- Sponsor's protocol ID
- TBA20241029
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Technology-Enhanced Horticultural Activities Among the People with Dementia and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06665243
- Acronym / sponsor ID
- TBA20241029
- Conditions
- Dementia, Caregiver Stress
- Keywords
- horticultural therapy, horticultural activities, people with dementia, family caregivers, informal caregivers, technology-enhanced horticultural activities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 Oct 2024 (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 goal of this study is to explore the effects of technology-enhanced horticultural activities on people with dementia (PWD) and their family caregivers. The main questions it aims to answer are:
- Do these activities improve cognitive function and behavioral symptoms in PWD?
- Do they reduce stress and depressive symptoms in caregivers and improve their quality of life?
The study will have two phases:
- Phase I: Conduct a pilot study with PWD in a geriatric day hospital to evaluate feasibility and initial effects.
- Phase II: Conduct a larger trial with PWD and caregivers in community settings to further assess impact.
Participants will engage in indoor horticultural activities using a smart grower, participate in training sessions, and complete assessments before and after the intervention.
Detailed description
Dementia is becoming a major worldwide concern as the world's population ages and the prevalence of dementia increases exponentially with age. As the disease progresses, people with dementia (PWD) exhibit different behavioral symptoms, and their cognitive function and self-care ability gradually decline. The burden of caring and the uncertainty about disease progression result in high levels of stress and negative emotions in family caregivers.
Horticultural therapy is an effective intervention that has been shown to increase the time PWD spend engaging in leisure activities and decrease the time they spend doing nothing. Importantly, horticultural therapy has demonstrated positive effects on alleviating agitation behaviors among PWD, including harmful aggressive and destructive behaviors. PWD can also benefit from improved cognitive function, psychological symptoms (e.g., stress, depression), and enhanced social interaction when participating in horticultural therapy.
However, there are limitations and constraints for PWD to participate in horticultural therapy, especially in high-density cities like Hong Kong. First, the majority of PWD and their family caregivers cannot afford to have a garden within their homes, as many developed cities suffer from limited land space, and it is common for PWD and their caregivers to live in small areas with simple furniture. Second, uncontrollable weather contributes to the difficulty in performing horticultural therapy in outdoor conditions, as plants are sensitive to weather and vulnerable to unstable conditions, especially the fickle weather in Hong Kong. Third, insufficient human resources lead to an increased chance of failure in outdoor horticultural therapy, as it requires ample manpower to look after the condition of various plants and assist PWD and their caregivers during the therapy sessions. Therefore, performing indoor technology-enhanced horticultural activities with a smart grower machine has the potential to reduce concerns about space, weather, and manpower.
The study consists of two phases. Phase I is a pilot pre-post feasibility study conducted in a geriatric day hospital setting with 30 PWD participants. It aims to assess whether indoor technology-enhanced horticultural activities improve cognitive function and behavioral symptoms in PWD. Phase II involves a larger-scale single-arm trial with 100 pairs of PWD and caregivers in community settings to evaluate the dyadic approach's impact on caregivers' stress levels and quality of life.
The intervention uses a smart grower, an indoor hydroponic system, to facilitate horticultural activities. A mobile app assists in controlling the environment and guiding participants. The program includes eight face-to-face sessions with various cognitive and sensory activities.
Primary outcomes for PWD include engagement, cognitive functioning, and challenging behaviors. Caregivers' outcomes focus on positive caregiving experiences, perceived stress, quality of life, and depressive symptoms. Feasibility is assessed through recruitment, attendance, completion, and retention rates. Evaluations will be conducted at baseline (0 weeks) and post-intervention (8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technology-enhanced horticultural activities | Experimental | Behavioral: Technology-enhanced horticultural activities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- aged 65 or above;
- diagnosed with any type of dementia at the early to moderate stage;
- community-dwelling (i.e., non-institutionalized); and
- able to understand Cantonese and follow simple instructions.
- aged 18 years or above;
Key exclusion criteria (3 listed)
- being diagnosed with a mental disorder such as bipolar disorder, schizophrenia, or depression;
- taking anticonvulsants or any kind of psychotropic drugs; and
- identified with self-reported suicidal thoughts or drug abuse in the past 6 months.
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 |
|---|---|---|
| Technology-enhanced horticultural activitiesThe indoor technology-enhanced horticultural activities will be delivered to people with dementia and their family caregivers through a smart grower. The smart grower is a hydroponic indoor grower that creates a controllable environment with auto optimization for growing healthy plants, fresh vegetables, herbs, and fruits. A mobile app will be connected to the grower for controlling the growing environment (e.g., lighting, watering), tracking the progress of the plants, and guiding the older people with dementia and their family caregivers in conducting the horticultural activities. The program will consist of eight face-to-face (F-T-F) horticultural activity training sessions for groups of 6-8 participants. The indoor program contains various horticultural, cognitive, and multisensory stimulation activities, such as asking PWD and family caregivers to record the sense of touch and odor when caring for the plants and to observe the various changes in the plants using the smart grower. | Behavioural | Technology-enhanced horticultural activities |
Primary outcome
PWD Outcome: Cognitive Functioning
Time frame: 8 Weeks
The MoCA-5-min will assess participants' cognitive function (Wong et al., 2015). It covers four domains: attention, executive function/language, orientation, and memory. The MoCA-5-min is highly correlated with the MoCA (r = 0.87) and has excellent test-retest reliability (ICC = 0.89). Trained nursing students will conduct the MoCA-5-min assessments.
PWD Outcome: Engagement
Time frame: 8 Weeks
The Engagement of a Person with Dementia Scale (EPWDS) assesses behavioral and emotional engagement in individuals with dementia during psychosocial activities (Jones et al., 2018). Based on the Observational Method of Engagement (Cohen-Mansfield et al., 2009), it evaluates five areas: affective, visual, verbal, behavioral, and social engagement. Each area includes two items-one for positive engagement and one for disengagement-resulting in 10 items total. Negatively phrased items are reverse scored, with total scores ranging from 10 to 50, where higher scores indicate greater positive engagement. The EPWDS has excellent reliability, with an internal consistency of 0.94 and a test-retest reliability of r = 0.95 (Jones et al., 2018). In this study, two trained nursing students will administer the EPWDS through direct observations and field notes. Inter-rater reliability will be calculated to ensure consistent assessments. Observations will last for 10 minutes and occur at T0 and T1.
PWD Outcome: Challenging Behaviors
Time frame: 8 Weeks
The Challenging Behaviors Subscale of the Dementia Coding System (DeCS) will measure challenging behaviors in BPSD during the intervention (Hillebrand et al., 2023). The DeCS uses a systematic time-sampling approach, observing individuals with dementia at specific intervals. The subscale includes 18 behaviors (e.g., apathetic, tense posture, runs away) recorded on a dichotomous scale, where 0 indicates not observed and 1 indicates observed. A higher score indicates more challenging behaviors. The subscale's internal consistency is 0.71, and the test-retest reliability is ICC = 0.92 (Hillebrand et al., 2023). Two trained nursing students will conduct observations and take field notes using the DeCS. Inter-rater reliability will be calculated to ensure consistency. Observations will be conducted over five four-minute intervals at T0 and T1.
PWD Outcome: Challenging Behaviors
Time frame: 8 Weeks
Challenging behaviors of the PWD will be measured by the Chinese version of the Neuropsychiatric Inventory-Questionnaire (NPI-Q) (Wong et al., 2014), administered by caregivers. It evaluates the frequency, severity, and caregiver distress of 12 neuropsychiatric symptoms using a 5-point rating scale. The NPI-Q has acceptable psychometric properties, including a high internal consistency (α = 0.76) and test-retest reliability (0.99).
Caregivers' Outcome: Positive Caregiving Experience
Time frame: 8 Weeks
The Chinese version of the Positive Aspect of Caregiving scale (PAC) (Lou et al., 2015) will measure participants' positive caregiving experience. The PAC scale demonstrates acceptable internal consistency (α = 0.85) among family caregivers of PWD in Hong Kong. Higher scores indicate more positive self-perceptions of caregiving.
Caregivers' Outcome: Perceived Stress Level
Time frame: 8 Weeks
The Chinese version of the Perceived Stress Scale (PSS) will measure participants' perceived stress (Leung et al., 2010). The PSS contains 10 items rated on a 5-point Likert scale from 0 (never) to 4 (very often). It has acceptable psychometric properties, including internal consistency (α = 0.85) and test-retest reliability (0.85) (Chu \& Kao, 2005; Leung et al., 2010).
Caregivers' Outcome: Quality of Life
Time frame: 8 Weeks
The WHOQOL-OLD BREF (HK) will assess participants' quality of life (QOL) (Leung et al., 2005). It comprises 28 items, each rated on a 5-point Likert scale from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating better QOL. The internal consistency of the Hong Kong Chinese version of the WHOQOL is satisfactory, with Cronbach's alpha ranging from 0.73 in the environment domain to 0.83 in the psychological domain, and a test-retest reliability coefficient of 0.83.
Caregivers' Outcomes: Depressive Symptoms
Time frame: 8 Weeks
The Chinese version of the Center for Epidemiological Studies Depression scale (CESDS) (Chin et al., 2015) will measure depression. It is a self-reported measure containing 20 items (Radloff, 1977). The CESD has acceptable psychometric properties, including test-retest reliability (0.91) and internal consistency for general depression (α = 0.86).
4 secondary outcomes
Feasibility Outcome: Recruitment Rate
Time frame: 8 Weeks
Feasibility Outcome: Attendance Rate
Time frame: 8 Weeks
Feasibility Outcome: Completion Rate
Time frame: 8 Weeks
Feasibility Outcome: Retention Rate
Time frame: 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enhanced horticultural activities in people with Dementia and Caregiver Stress, run by The Hong Kong Polytechnic University.
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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Kor, PhD (852-27665622, patrick.kor@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PWD Outcome: Cognitive Functioning (time frame: 8 Weeks). The study lists 8 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 30 Oct 2024.