NCT03045718

Brief Summary

The objective of this study is to determine whether horticultural therapy would improve the psychological well-being older adults who are at risk of memory (cognitive) decline. 100 elderly subjects who are at risk of cognitive decline will be randomized into the active horticultural therapy or to the waitlist control group. Sessions will be conducted weekly for 9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3 months and at 9 months. It is hypothesized that participants who undergo horticultural therapy will perform better on neuropsychological tests when compared to control, and that they will have improved psychological well-being and functional outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

February 5, 2017

Last Update Submit

February 5, 2017

Conditions

Keywords

Horticultural TherapyDementiaRandomized Controlled TrialElderlyPrevention

Outcome Measures

Primary Outcomes (6)

  • Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months

    Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care.

    Baseline, 9 months

  • Changes in Colour Trails Tests (CTT) scores at baseline, 3 months and 9 months

    Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing.

    Baseline, 3 months, 9 months

  • Changes in Digit Span Task scores at baseline, 3 months and 9 months

    Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory.

    Baseline, 3 months, 9 months

  • Changes in Rey Auditory Verbal Learning Test (RAVLT) scores at baseline, 3 months and 9 months

    Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.

    Baseline, 3 months, 9 months

  • Changes in Block Design scores at baseline, 3 months and 9 months

    Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills

    Baseline, 3 months, 9 months

  • Changes in Semantic Verbal Fluency scores at baseline, 3 months and 9 months

    Semantic Verbal Fluency assess lexical knowledge and semantic memory organization.

    Baseline, 3 months, 9 months

Secondary Outcomes (8)

  • Changes in Zung Self-Rating Depression Scale (SDS) scores at baseline, 3 months and 9 months

    Baseline, 3 months, 9 months

  • Changes in Zung Self-Rating Anxiety Scale (SAS) scores at baseline, 3 months and 9 months

    Baseline, 3 months, 9 months

  • Changes in Ryff's Scales of Psychological Well-being scores at baseline, 3 months and 9 months

    Baseline, 3 months, 9 months

  • Changes in Friendship Scale (FS) scores at baseline, 3 months and 9 months

    Baseline, 3 months, 9 months

  • Changes in EuroQol Five Dimensions Questionaire (ED-5D-3L) scores at baseline, 3 months and 9 months

    Baseline, 3 months, 9 months

  • +3 more secondary outcomes

Study Arms (2)

Horticultural Therapy

EXPERIMENTAL

Horticultural Therapy will consists of 1 hour sessions, weekly for 9 months, to engage subjects in gardening-based activities.

Behavioral: Horticultural Therapy

Waitlist Control

OTHER

The control group will be placed on a waiting list and only be contacted for assessments. They will receive the same Horticultural Therapy intervention after the active treatment group at a later date.

Behavioral: Horticultural Therapy

Interventions

The Horticultural Therapy intervention will be delivered by trained facilitators at the Therapeutic Garden at Hort Park, and consists of 1 hour sessions weekly for 9 months. The Horticultural Therapy program is designed to stimulate the senses through interaction with the tasks and the environment, promote social interaction and also to promote a sense of self-worth through completion of projects. It encompasses a range of activities including general gardening and also project-based craft activities.

Horticultural TherapyWaitlist Control

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Community-living elderly aged 60 years and above, AND 2.
  • Mild Cognitive Impairment based on clinical history and neuropsychological test scores (Z score \<0 and \>-1.5), OR
  • Subjective Memory Impairment based on self-report, OR (C) 2 or more risk factors for dementia such as family history, cerebrovascular disease, and cardiovascular risk factors

You may not qualify if:

  • Existing diagnosis of dementia, OR
  • Comorbid major mental illness (such as Major Depressive Disorder and Psychosis), OR
  • Severe or unstable life-limiting medical illness, OR
  • Severe physical impairment precluding participation in Horticultural Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (5)

  • Soga M, Gaston KJ, Yamaura Y. Gardening is beneficial for health: A meta-analysis. Prev Med Rep. 2016 Nov 14;5:92-99. doi: 10.1016/j.pmedr.2016.11.007. eCollection 2017 Mar.

    PMID: 27981022BACKGROUND
  • Blake M, Mitchell G. Horticultural therapy in dementia care: a literature review. Nurs Stand. 2016 Jan 20;30(21):41-7. doi: 10.7748/ns.30.21.41.s44.

    PMID: 26786461BACKGROUND
  • Noone S, Innes A, Kelly F, Mayers A. 'The nourishing soil of the soul': The role of horticultural therapy in promoting well-being in community-dwelling people with dementia. Dementia (London). 2017 Oct;16(7):897-910. doi: 10.1177/1471301215623889. Epub 2015 Dec 23.

    PMID: 26701960BACKGROUND
  • Kamioka H, Tsutani K, Yamada M, Park H, Okuizumi H, Honda T, Okada S, Park SJ, Kitayuguchi J, Abe T, Handa S, Mutoh Y. Effectiveness of horticultural therapy: a systematic review of randomized controlled trials. Complement Ther Med. 2014 Oct;22(5):930-43. doi: 10.1016/j.ctim.2014.08.009. Epub 2014 Sep 1.

    PMID: 25440385BACKGROUND
  • Annerstedt M, Wahrborg P. Nature-assisted therapy: systematic review of controlled and observational studies. Scand J Public Health. 2011 Jun;39(4):371-88. doi: 10.1177/1403494810396400. Epub 2011 Jan 27.

    PMID: 21273226BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Horticultural Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hong Yee Tan, MMed(Psy)

    Associate Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 7, 2017

Study Start

January 1, 2017

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

February 7, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared, in the interests of subject confidentiality

Locations