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临床试验/NCT07059390
NCT07059390尚未招募不适用

Changi General Hospital Complementary Health Therapy

Changi General Hospital1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2027年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,600
试验地点
1
主要终点
Pittsburg Agitation Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with dementia:
  • Age 65-100 years old
  • Have a diagnosis of delirium/ dementia or both.
  • Have diagnosis of dementia with and without behavioural symptoms of dementia (BPSD)
  • Ability to communicate with the Nature-based Therapist (in languages such as English, Mandarin Chinese, Chinese dialects or Malay)
  • Manageable behavioural symptoms and able to focus attention for minimum of 30 minutes
  • Rehabilitation Medicine patients:
  • Age 21-100 years old
  • 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
  • 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)

排除标准

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

结局指标

主要结局

Pittsburg Agitation Scale

时间窗: 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

时间窗: 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.

次要结局

  • EQ-5D-5L(Baseline and at the end of intervention, an average of 7 days)
  • Zarit Burden Interview(Baseline and at the end of intervention, an average of 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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