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DementiaNCT05577975

Pilot Evaluation of Technology-enhanced Horticultural Activities Among the People With Dementia and Their Family Caregivers

A study testing The Aspara @ smart grower in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Horticultural therapy is one of the effective interventions for the person with dementia(PWD) which could increase their time engaging in leisure activities and decrease their time doing nothing. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
The Aspara @ smart grower
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
1 Sep 2022to 30 Aug 2024
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

  • The PWD
  • Aged 65 or above who had been diagnosed with any type of dementia at the early to moderate stage
  • Are Community-dwelling (i.e., non-institutionalized),
  • Are Able to understand Cantonese and follow simple instruction
  • The family caregivers
  • Aged 18 years or above;
Show all 9Show fewer
  • the 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 types and these relatives are taking up the caring responsibilities ranging from physical aids to emotional supports, 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

  • The PWD and the family caregivers
  • Are diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression; and/or,
  • Are taking anticonvulsants, or any kind of psychotropic drugs, and/or identified with a self-reported suicidal thought or drug abuse in the past 6 months.

Trial locations and contacts

1 site in 1 country.

Patrick Kor, PhD contact

27665622

patrick.kor@polyu.edu.hk

Hong Kong1 site, 1 recruiting

  • The Hong Kong Polytechnic Univeristy

    Hong Kong

    Patrick Kor, 27665622, patrick.kor@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Horticultural therapy is one of the effective interventions for the person with dementia(PWD) which could increase their time engaging in leisure activities and decrease their time doing nothing. However, there are some limitations and constraints for PWD to participate in the horticultural therapy especially in the high-density cities (e.g. Hong Kong). This study aims to investigate the feasibility and preliminary effects of adopting home-based technology-enhanced horticultural activities. The program will consist of three face-to-face (F-T-F) horticultural activity training session for a group of 6-8 participants and then biweekly telephone follow-up for 8-week home-based horticultural intervention. Program evaluation will be conducted through focus groups with 15 participants with different levels of stress reduction after the intervention. It is hypothesized that the PWD and their caregiver will have a significant improvement in the cognitive function and behavioral symptoms of the PWD, an increase in the positive caregiving experience in the family caregivers, a reduction of the caregivers' level of stress and depressive symptoms, and enhancement of the quality of life of the family caregivers after the intervention.

Read the detailed description

Objective This study aims to investigate the feasibility and preliminary effects of adopting home-based technology-enhanced horticultural activities to: a) improve the cognitive function and behavioral symptoms of the PWD; b) promote the positive caregiving experience in the family caregivers; c) reduce the caregivers' level of stress and depressive symptoms; and d) improve the quality of life of the family caregivers. To the best of our knowledge, it is the first program adopting Smart Grower for horticultural intervention among the PWD and their family caregivers in Hong Kong.

Method The home-based technology-enhanced horticultural activities will be delivered for the people with dementia and their family caregivers through a smart grower. The smart grower is a hydroponic indoor grower that builds 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, guiding the older people with dementia and their family caregiver to conduct the horticulture activities. The program will consist of three face-to-face (F-T-F) horticultural activity training session for a group of 6-8 participants and then biweekly telephone follow-up for 8-week home-based horticultural intervention. The home-based program contains different horticultural, cognitive and multisensory stimulation activities such asking the PWD and the family caregiver to record the sense of touch and odor when taking care of the plant and the various changes of the plants by using the smart grower. Program evaluation will be conducted through focus groups with 15 participants with different levels of stress reduction after the intervention. The aims of the focus groups is to identify the strengths, limitations, and difficulties of the home-based technology-enhanced horticultural program.

Significance and Value In this project, we would like to collaborate with the elderly center to deliver the technology-enhanced horticultural activities for PWD in the community and make this program sustainable in the community. Meanwhile, we will collect the users' feedback and further modify the program to fit the needs of the people with dementia and the family caregivers.

In the future, we hope that the program will not only benefit the community-dwelling older people but also those receiving service in the respite center, day care center, hospice and nursing home as they are also facing the challenges of manpower shortage, issues of loneness and poor psychological health. We will base on the data and results collected from this proposed study and further revise the program and software for servicing the older people in nursing through a group-based approach.

Conditions
Dementia
Being tested
The Aspara @ smart grower
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Aspara @ smart growerDevice

    The program will consist of three face-to-face (F-T-F) horticultural activity training session for a group of 6-8 participants and then biweekly telephone follow-up for 8-week home-based horticultural intervention. The home-based program contains different horticultural, cognitive and multisensory stimulation activities such asking the PWD and the family caregiver to record the sense of touch and odor when taking care of the plant and the various changes of the plants by using the smart grower. Program evaluation will be conducted through focus groups with 15 participants with different levels of stress reduction after the intervention.

Study groups in NCT05577975
Study groupRoleWhat they receive
Intervention ArmExperimentalThe program will consist of three face-to-face (F-T-F) horticultural activity training session for a group of 6-8 participants and then biweekly telephone follow-up for 8-week home-based horticultural intervention.
Receives: Device: The Aspara @ smart grower

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Chinese version of Positive Aspect of Caregiving scale (PAC)

    The PAC scale demonstrates the acceptable levels of internal consistency Cronbach's alpha 0.85 among the family caregivers of PWD in Hong Kong. Higher scores indicating more positive self-perceptions of caregiving. Comparisons of changes of Positive Aspect of Caregiving scale (PAC)will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

  2. The Chinese version of Perceived Stress Scale (PSS)

    Perceived Stress Scale contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). The total score can range from 0 to 40 with higher scores indicating higher perceived stress. Comparisons of changes of Perceived Stress Scale will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

  3. The WHOQOL-OLD BREF (HK)

    The WHOQOL-OLD BREF (HK) comprised 28 items and each item is rated on a 5-point Likert-type scale that ranged from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating a better QoL. Comparisons of changes of The WHOQOL-OLD BREF (HK) will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

  4. The Chinese version of Center for Epidemiological Studies Depression scale(CESDS)

    The Chinese version of Center for Epidemiological Studies Depression scale is a self-reported measure of depression containing 20 items. Comparisons of changes of Center for Epidemiological Studies Depression scale will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

  5. MoCA-5-min

    MoCA-5-min assess participants' cognitive function over the telephone. MoCA-5-min comprises four domains: attention, executive function/language, orientation, and memory.Comparisons of changes of MoCA-5-min will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

  6. The Chinese version of the Neuropsychiatric Inventory-Questionnaire (NPI-Q)

    The Neuropsychiatric Inventory-Questionnaire evaluates the frequency, severity, and caregiver distress of 12 neuropsychiatric symptoms by using a 5-point rating scale..Comparisons of changes of the Neuropsychiatric Inventory-Questionnaire will be considered as follows: T0 - T1

    Measured: At baseline (T0) and 11th week (immediately post- intervention; T1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577975
Sponsor's protocol ID
HSEARS20220801002
Status last verified
Oct 2022
First submitted
10 Oct 2022
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chau, P. H., McGhee, S. M., Yu, R., Cheung, W. L., Chan, K. C., Cheung, S. H., & Woo, J. (2010). Dementia Trends: Impact of the Ageing Population and Societal Implications for Hong Kong. Hong Kong: The Hong Kong Jockey Club.

  • Chin WY, Choi EP, Chan KT, Wong CK. The Psychometric Properties of the Center for Epidemiologic Studies Depression Scale in Chinese Primary Care Patients: Factor Structure, Construct Validity, Reliability, Sensitivity and Responsiveness. PLoS One. 2015 Aug 7;10(8):e0135131. doi: 10.1371/journal.pone.0135131. eCollection 2015.

    PubMed 26252739

  • Chu, L. C., & Kao, H. S. (2005). The moderation of meditation experience and emotional intelligence on the relationship between perceived stress and negative mental health (Vol. 47).

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Laver K, Milte R, Dyer S, Crotty M. A Systematic Review and Meta-Analysis Comparing Carer Focused and Dyadic Multicomponent Interventions for Carers of People With Dementia. J Aging Health. 2017 Dec;29(8):1308-1349. doi: 10.1177/0898264316660414. Epub 2016 Jul 25.

    PubMed 27458254

  • Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.

    PubMed 20735860

  • Lin Y, Lin R, Liu W, Wu W. Effectiveness of horticultural therapy on physical functioning and psychological health outcomes for older adults: A systematic review and meta-analysis. J Clin Nurs. 2022 Aug;31(15-16):2087-2099. doi: 10.1111/jocn.16095. Epub 2021 Oct 24.

    PubMed 34694042

  • Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.

    PubMed 25488014

  • Lu LC, Lan SH, Hsieh YP, Yen YY, Chen JC, Lan SJ. Horticultural Therapy in Patients With Dementia: A Systematic Review and Meta-Analysis. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317519883498. doi: 10.1177/1533317519883498. Epub 2019 Nov 5.

    PubMed 31690084

  • Ng KST, Sia A, Ng MKW, Tan CTY, Chan HY, Tan CH, Rawtaer I, Feng L, Mahendran R, Larbi A, Kua EH, Ho RCM. Effects of Horticultural Therapy on Asian Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Aug 9;15(8):1705. doi: 10.3390/ijerph15081705.

    PubMed 30096932

  • Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.

    PubMed 23305823

  • Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401.

  • Van't Leven N, Prick AE, Groenewoud JG, Roelofs PD, de Lange J, Pot AM. Dyadic interventions for community-dwelling people with dementia and their family caregivers: a systematic review. Int Psychogeriatr. 2013 Oct;25(10):1581-603. doi: 10.1017/S1041610213000860. Epub 2013 Jul 24.

    PubMed 23883489

  • Wong A, Cheng ST, Lo ES, Kwan PW, Law LS, Chan AY, Wong LK, Mok V. Validity and reliability of the neuropsychiatric inventory questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):247-52. doi: 10.1177/0891988714532017. Epub 2014 Apr 24.

    PubMed 24763069

  • Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.

    PubMed 25700290

Questions about this trial

What is this clinical trial studying?

A study testing The Aspara @ smart grower in people with Dementia, run by The Hong Kong Polytechnic 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 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick Kor, PhD (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?

The Chinese version of Positive Aspect of Caregiving scale (PAC) (time frame: At baseline (T0) and 11th week (immediately post- intervention; T1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05577975, which also lists 19 linked publications.

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 Oct 2022.

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