Clinical trial NCT06665243: Horticultural Activities Among the People with Dementia and Their Family Caregivers
Official title: Effects of Technology-Enhanced Horticultural Activities Among the People with Dementia and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Caregiver Stress
Keywords: horticultural therapy
horticultural activities
people with dementia
family caregivers
informal caregivers
technology-enhanced horticultural activities
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria (PWD):

* 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.

Inclusion Criteria (Caregivers)

* 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.

Exclusion Criteria (PWD + Caregivers):

* 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.

Primary outcomes:
measure: PWD Outcome: Cognitive Functioning
timeFrame: 8 Weeks
measure: PWD Outcome: Engagement
timeFrame: 8 Weeks
measure: PWD Outcome: Challenging Behaviors
timeFrame: 8 Weeks
measure: PWD Outcome: Challenging Behaviors
timeFrame: 8 Weeks
measure: Caregivers' Outcome: Positive Caregiving Experience
timeFrame: 8 Weeks
measure: Caregivers' Outcome: Perceived Stress Level
timeFrame: 8 Weeks
measure: Caregivers' Outcome: Quality of Life
timeFrame: 8 Weeks
measure: Caregivers' Outcomes: Depressive Symptoms
timeFrame: 8 Weeks
Secondary outcomes:
measure: Feasibility Outcome: Recruitment Rate
timeFrame: 8 Weeks
measure: Feasibility Outcome: Attendance Rate
timeFrame: 8 Weeks
measure: Feasibility Outcome: Completion Rate
timeFrame: 8 Weeks
measure: Feasibility Outcome: Retention Rate
timeFrame: 8 Weeks
Other outcomes:
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