Concurrent Trials on Nature-Based Therapy for Inpatients in Dementia and Rehabilitation Medicine Wards

Not Applicable

Not yet recruiting

• Conditions: Dementia; Acquired Brain Injury Including Stroke

• Registration Number: NCT07059390
• Lead Sponsor: Changi General Hospital

Brief Summary

Nature-based Therapy, such as forest bathing and horticultural therapy, has been shown to have physical, psychological and emotional health benefits. We posit that personalised and guided Nature-based Therapy, which leverages the benefits of therapeutic gardens in an urban hospital setting, improves the overall wellbeing of elderly inpatients with dementia (aged \>65 years old) and their caregivers, as well as patients undergoing inpatient rehabilitation. To determine the effectiveness of Nature-based Therapy for these two inpatient populations, we designed a pilot study, TGIF, to be conducted at the dementia and rehabilitation medicine wards at Changi General Hospital in Singapore.

Detailed Description

TGIF consists of two concurrent trials targeting two patient populations: elderly inpatients with dementia admitted to the dementia ward, and inpatients undergoing inpatient rehabilitation at the rehabilitation wards in a tertiary teaching hospital in Singapore. At the dementia wards, we aim to determine if Nature-based Therapy improved the neuropsychiatric symptoms such as agitation, restlessness and aggression among elderly inpatients living with cognitive impairment, defined as either delirium or dementia or both. Concurrent with the improved neuropsychiatric symptoms, the study team will also study the improved quality of life among the family, caregivers and hence reduced caregiver burden. At the rehabilitation medicine wards, we aim to determine if Nature-based Therapy improves mood, physical function, and quality of life.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Study Start: 2025-08-01
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Patients with dementia:

1. Age 65-100 years old
2. Have a diagnosis of delirium/ dementia or both.
3. Have diagnosis of dementia with and without behavioural symptoms of dementia (BPSD)
4. Ability to communicate with the Nature-based Therapist (in languages such as English, Mandarin Chinese, Chinese dialects or Malay)
5. Manageable behavioural symptoms and able to focus attention for minimum of 30 minutes

Rehabilitation Medicine patients:

1. Age 21-100 years old
2. Acquired brain injury with residual impairments, which can be either in the i) motor, and/or ii) cognitive domains, and/or iii) suspected or diagnosed mood disorders (including adjustment disorder, depression and anxiety disorders) -patients would then be stratified according to the category(s) of impairments both for consideration of interventions and for outcome measures/analysis
3. Additional Physical/Cognitive Criteria required will depend on range of specific therapeutic activities that could be prescribed/administered (eg.at least 1 upper limb with Manual Muscle Testing (MMT) of at least 3/5, with ability for active grasp/release, ability to sustain attention for the duration of the session, cognitive Functional Independence Measure (FIM) score of at least 25 points etc)

Exclusion Criteria

1. In isolation due to contact, droplet or airborne precautions
2. Unable to provide consent and lack of surrogate decision maker to provide consent
3. Poorly managed psychiatric or behaviour symptoms with threats to others surrounding them.
4. Age < 21 years
5. Patients who are haemodynamically unstable.
6. Patients on strict bed rest

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pittsburg Agitation Scale	Baseline and at the end of intervention, an average 7 days	The Pittsburgh Agitation Scale (PAS) is a quick, observational tool used to assess the severity of agitation in dementia patients, focusing on four behavioral dimensions: aberrant vocalizations, motor agitation, aggressiveness, and resistance to care
DASS-21	Baseline and at the end of intervention, an average of 7 days	The DASS-21 (Depression, Anxiety, and Stress Scale - 21 Items) is a self-report questionnaire designed to measure the severity of symptoms related to depression, anxiety, and stress in adults. It consists of 21 questions, with seven questions for each of the three scales: depression, anxiety, and stress.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Baseline and at the end of intervention, an average of 7 days	The EQ-5D-5L is a generic, self-completed questionnaire that assesses health-related quality of life (HRQoL) across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity for each dimension, and includes a visual analogue scale (EQ VAS).
Zarit Burden Interview	Baseline and at the end of intervention, an average of 7 days	The Zarit Burden Interview (ZBI) is a widely used tool to assess the level of caregiver burden experienced by individuals who care for people with chronic illnesses. It is a self-report questionnaire that evaluates the physical, emotional, and social impact of caregiving on the caregiver's well-being.

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore