NCT06665243

Brief 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 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Nov 2024Nov 2027

First Submitted

Initial submission to the registry

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

October 28, 2024

Last Update Submit

October 28, 2024

Conditions

Keywords

horticultural therapyhorticultural activitiespeople with dementiafamily caregiversinformal caregiverstechnology-enhanced horticultural activities

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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).

    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.

    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).

    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.

    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).

    8 Weeks

Secondary Outcomes (4)

  • Feasibility Outcome: Recruitment Rate

    8 Weeks

  • Feasibility Outcome: Attendance Rate

    8 Weeks

  • Feasibility Outcome: Completion Rate

    8 Weeks

  • Feasibility Outcome: Retention Rate

    8 Weeks

Study Arms (1)

Technology-enhanced horticultural activities

EXPERIMENTAL
Behavioral: Technology-enhanced horticultural activities

Interventions

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.

Technology-enhanced horticultural activities

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share