UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046269
Receipt number R000052800
Scientific Title Effects of Virtual Horticultural Therapy on Quality of Life and Emotions in Elderly Care Facility
Date of disclosure of the study information 2021/12/06
Last modified on 2023/06/29 13:04:09

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Basic information

Public title

Effects of Virtual Horticultural Therapy on Quality of Life and Emotions in Elderly Care Facility

Acronym

Effects of Virtual Horticultural Therapy on Quality of Life and Emotions in Elderly Care Facility

Scientific Title

Effects of Virtual Horticultural Therapy on Quality of Life and Emotions in Elderly Care Facility

Scientific Title:Acronym

Effects of Virtual Horticultural Therapy on Quality of Life and Emotions in Elderly Care Facility

Region

Japan


Condition

Condition

Elderly people in facility

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to clarify the impact of virtual horticultural therapy on the QOL and Emotions of elderly residents in institutions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

quality of life

Key secondary outcomes

Emotion, cognitive function, ikigai


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

horticultural activities

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who have been admitted to an elderly care facility
Those who can communicate
Those who can sit up
Those who have consented to this study

Key exclusion criteria

Those who are unable to communicate
Those who are unable to sit up
Those who did not agree with this study

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Miyake

Organization

Kibi International University

Division name

Department of Occupational therapy

Zip code

7168508

Address

8, iga-cho, Takahashi

TEL

0866229454

Email

miyake-y@kiui.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Miyake

Organization

Kibi International University

Division name

Department of Occupational therapy

Zip code

7168508

Address

8, iga-cho, Takahashi

TEL

0866229454

Homepage URL


Email

miyake-y@kiui.ac.jp


Sponsor or person

Institute

Kibi International University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kibi International University

Address

8, iga-cho, Takahashi

Tel

0866229454

Email

miyake-y@kiui.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 12 Month 06 Day

Date of IRB

2021 Year 12 Month 15 Day

Anticipated trial start date

2021 Year 12 Month 06 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 12 Month 03 Day

Last modified on

2023 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name