FrailtyNCT04654949
Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital
A study testing Horticultural Therapy in people with Frailty and Hospitalism, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Hospitalism
- What is being tested?
- Horticultural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Aug 2019to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Frailty, Hospitalism
- Being tested
- Horticultural Therapy
- Keywords
- Horticultural Therapy, Randomized controlled trial
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Horticultural Therapy | Experimental | 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. Receives: Other: Horticultural Therapy |
| Existing Care | No intervention | The existing Care group receives 30 minutes of routine ward-based engagement leisure activities (e.g. watching television, reading newspapers, etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five days
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.
Measured: Five days
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.
Measured: Five days
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.
Measured: Five days
Secondary outcomes (3)
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.
Measured: Five days
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.
Measured: 5 days
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.
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start6 Aug 2019
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thuy-Anh Giang, Principal investigator, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654949
- Sponsor's protocol ID
- 2019/00211
- Other IDs
- 2019
- Status last verified
- Aug 2023
- First submitted
- 27 Oct 2020
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31402135
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04654949
- Acronym / sponsor ID
- 2019/00211
- Conditions
- Frailty, Hospitalism
- Keywords
- Horticultural Therapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horticultural Therapy | Experimental | Other: Horticultural TherapyThe 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. |
| Existing Care | No intervention | –The existing Care group receives 30 minutes of routine ward-based engagement leisure activities (e.g. watching television, reading newspapers, etc). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horticultural TherapyThe 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. | Other | Horticultural Therapy |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Number of Transitions in the Mobility Status
Time frame: Five days
Change in Emotion Assessed by Emoticon Scale
Time frame: 5 days
Hospitalisation Experience Questionnaire
Time frame: Five days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Background: PubMed 31402135Nicholas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thuy-Anh Giang principal investigator
Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horticultural Therapy in people with Frailty and Hospitalism, run by Khoo Teck Puat Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Score of Engagement Assessed by Menorah Park Engagement Scale (MPES) (time frame: Five days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.