- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04654949
Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital
Pilot Pragmatic Randomized Controlled Trial: The Effects of Horticultural Therapy (HT) vs Existing Care on Engagement, Mood and Mobility of Inpatient Older Adults in an Acute Care Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thuy-Anh Giang
- Phone Number: (65)66023105
- Email: giang.thuy.anh@ktph.com.sg
Study Locations
-
-
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Singapore, Singapore, 768828
- Khoo Teck Puat Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 70 years old and above
- an inpatient in Khoo Teck Puat Hospital
- able to understand simple instructions (with abbreviated mental test's score of 6 and above)
- have stable vital signs - blood pressure, heart rate and peripheral capillary oxygen saturation - to take part in horticultural therapy activities
Exclusion Criteria:
- on contact or droplet precaution
- diagnosed with severe auditory-visual impairments
- have major depressive disorder
- have endocrine disorders
- on steroid-based medications such as asthma and allergies that might affect the salivary cortisol level
- on the Dangerously Ill List
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Horticultural Therapy
The Horticultural Therapy group receives 30 minutes of horticultural therapy activities using mobile horticulture kits conducted by therapists or therapy assistants to engage participants at their bedside.
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The horticultural therapy sessions are conducted by the occupational therapists or therapy assistants using the mobile horticultural kits.
The horticultural activities are designed to stimulate the senses through interaction with specific tasks and the environment, promote social interaction, mobility and also promote a sense of self-worth through various horticultural activities such as planting seeds, transplanting plants, trimming and watering plants.
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No Intervention: Existing Care
The existing Care group receives 30 minutes of routine ward-based engagement leisure activities (e.g.
watching television, reading newspapers, etc).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Score of Engagement Assessed by Menorah Park Engagement Scale (MPES)
Time Frame: Five days
|
MPES consists of four different types of engagement: "constructive", "passive", "self" and "none" (Judge, Camp & Orsulic-Jeras, 2000). Each type of engagement is recorded on five-minutes intervals during the 30-minutes sessions for both intervention and control group. The score of 0, 1 and 2 represent engagement "not observed", "observed for less than two and a half minutes" and "observed for more than two and a half minutes" respectively. The average score of each type of engagement for all sessions during assessment period is compared between the two groups. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Average Score of Mood Assessed by Apparent Affect Rating Scale (AARS)
Time Frame: Five days
|
AARS consists of five different domains of mood: pleasure, general alertness, anxiety/ fear, anger and sadness (Lawton, Haitsma & Klapper, 1996). Each domain of mood is recorded on five-minutes intervals during the 30-minutes sessions for both intervention and control group. The score of 0, 1 and 2 represent engagement "not observed", "observed for less than two and a half minutes" and "observed for more than two and a half minutes" respectively. The average score of each domain of mood for all sessions during assessment period is compared between the two groups. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Change in Mobility Performance Assessed by Modified Perme ICU scale
Time Frame: Five days
|
Change in mobility performance from baseline (before randomization) to last session during the assessment period is measured by the modified Perme ICU scale (Perme, Nawa, Winkelman & Masud, 2014). The mobility domains of "bed mobility", "transfers" and "gait" are recorded with the score of 0 to 7, indicates for "total assistance", "maximum assistance", "moderate assistance", "minimal assistance", "contact guard", "standby assistance", "supervision" and "independent" respectively. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Change in Quality of Life Assessed by the EQ-5D
Time Frame: Five days
|
Change in quality of life is measured by the change in the score of the EuroQol EQ-5D from baseline (before randomization) to last session during the assessment period (Brooks & Charro, 1996). The EQ-5D covers five dimensions on health status - mobility, self-care, usual activities and anxiety/depression using 5 response levels - no problem, slight problem, moderate problem, severe problem and extreme problem. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Transitions in the Mobility Status
Time Frame: Five days
|
Participants' mobility state at the start of the session, the highest mobility state during session and the number of transitions in the mobility are captured using the mobilisation scale. The average score of highest mobility status and number of transitions in the mobility are compared between intervention and control group. The higher the score indicates better outcome. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Change in Emotion Assessed by Emoticon Scale
Time Frame: 5 days
|
The Emoticon Scale consists of seven simple emotion icons with smiling faces (A/1-C/3), a neutral face (D/4), and frowning faces (E/5-G/7) on a Likert scale (Tan et al., 2018). Participants are asked to rate their mood at point of assessment at baseline (before randomisation) and at the last session of the assessment period. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
5 days
|
Hospitalisation Experience Questionnaire
Time Frame: Five days
|
It is a 10-self administered questionnaire modified from the Person-centered care assessment tool (PCAT) (Edvardsson et al., 2010) which aims to evaluate the quality of health care settings as perceived by patients. The score is Likert scale from 0 to 5, with 0 indicating "No, I disagree completely" and 5 indicating "Yes, I agree completely". Hospitalisation Experience Questionnaire is administered at the last session of the assessment period. The assessment period is five days, or from recruitment date to participants' discharge date from the acute care hospital. |
Five days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thuy-Anh Giang, Khoo Teck Puat Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/00211
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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