Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital
Primary Purpose
Frailty, Hospitalism
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Horticultural Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty focused on measuring Horticultural Therapy, Randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- Khoo Teck Puat Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Horticultural Therapy
Existing Care
Arm Description
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.
The existing Care group receives 30 minutes of routine ward-based engagement leisure activities (e.g. watching television, reading newspapers, etc).
Outcomes
Primary Outcome Measures
Average Score of Engagement Assessed by Menorah Park Engagement Scale (MPES)
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.
Average Score of Mood Assessed by Apparent Affect Rating Scale (AARS)
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.
Change in Mobility Performance Assessed by Modified Perme ICU scale
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.
Change in Quality of Life Assessed by the EQ-5D
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.
Secondary Outcome Measures
Number of Transitions in the Mobility Status
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.
Change in Emotion Assessed by Emoticon Scale
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.
Hospitalisation Experience Questionnaire
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.
Full Information
NCT ID
NCT04654949
First Posted
October 27, 2020
Last Updated
August 24, 2023
Sponsor
Khoo Teck Puat Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04654949
Brief Title
Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Khoo Teck Puat Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to investigate the feasibility and effectiveness of Horticultural Therapy (HT) on engagement, mood, and quality of life (QoL) of older adults in geriatric acute care in Singapore. Investigators will also assess the effectiveness of HT on mobility and hospitalisation experience. This pilot study could inform how HT can be implemented in geriatric acute care and its effect on hospitalisation experience and recovery of function.
Detailed Description
Horticultural therapy (HT) is a non-pharmacological treatment utilizing plant-related activities as a form of alternative medicine to achieve specific goals that lead to person's well-being. Geriatric patients in acute care wards are at risk of functional decline related to acute illness and prolonged bed rest during hospitalization. HT can complement medical treatment to ameliorate the adverse effects of hospitalisation in older adults. There is evidence that HT can improve the physical and psychological well-being of the older adults in different settings. The beneficial effects of HT have mostly been documented in nursing homes, community rehabilitation facilities and senior activity centres, but not in geriatric acute care settings. There is also a need to harness available knowledge and implement it where appropriate. This study aims to investigate the feasibility and effectiveness of HT on engagement, mood, and quality of life (QoL) of older adults in geriatric acute care in Singapore. Investigators will also assess the effectiveness of HT on mobility and hospitalisation experience. This pilot study could inform how HT can be implemented in geriatric acute care and its effect on hospitalisation experience and recovery of function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Hospitalism
Keywords
Horticultural Therapy, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Horticultural Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Existing Care
Arm Type
No Intervention
Arm Description
The existing Care group receives 30 minutes of routine ward-based engagement leisure activities (e.g. watching television, reading newspapers, etc).
Intervention Type
Other
Intervention Name(s)
Horticultural Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Score of Engagement Assessed by Menorah Park Engagement Scale (MPES)
Description
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.
Time Frame
Five days
Title
Average Score of Mood Assessed by Apparent Affect Rating Scale (AARS)
Description
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.
Time Frame
Five days
Title
Change in Mobility Performance Assessed by Modified Perme ICU scale
Description
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.
Time Frame
Five days
Title
Change in Quality of Life Assessed by the EQ-5D
Description
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.
Time Frame
Five days
Secondary Outcome Measure Information:
Title
Number of Transitions in the Mobility Status
Description
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.
Time Frame
Five days
Title
Change in Emotion Assessed by Emoticon Scale
Description
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.
Time Frame
5 days
Title
Hospitalisation Experience Questionnaire
Description
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.
Time Frame
Five days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thuy-Anh Giang
Organizational Affiliation
Khoo Teck Puat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
768828
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
31402135
Citation
Nicholas SO, Giang AT, Yap PLK. The Effectiveness of Horticultural Therapy on Older Adults: A Systematic Review. J Am Med Dir Assoc. 2019 Oct;20(10):1351.e1-1351.e11. doi: 10.1016/j.jamda.2019.06.021. Epub 2019 Aug 8.
Results Reference
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Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital
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