UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038868 |
|---|---|
| Receipt number | R000040454 |
| Scientific Title | A study on development of horticultural activities program for community volunteer aimed at prevention and understanding of dementia |
| Date of disclosure of the study information | 2019/12/12 |
| Last modified on | 2024/04/01 16:16:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on development of horticultural activities program for community volunteer aimed at prevention and understanding of dementia
Acronym
A study on development of horticultural activities program for community volunteer aimed at prevention and understanding of dementia
Scientific Title
A study on development of horticultural activities program for community volunteer aimed at prevention and understanding of dementia
Scientific Title:Acronym
A study on development of horticultural activities program for community volunteer aimed at prevention and understanding of dementia
Region
| Japan |
Condition
Condition
Demetia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to develop a horticultural activity program that encourages active interaction between older people with dementia and senior volunteers living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Horticultural activity records
Key secondary outcomes
Individual horticultural activity records, Behaviors symptomatic of dementia in daily life during the past month, Acceptance of dementia, Semi-structured interview
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
User: Among elderly people over 65 years of age who are using small and multifunctional functions, those who have a dementia rank of IIa or higher and can hold a sitting position.
Volunteer: A person who is over 60 years of age who is willing to do volunteer activities in a small, multifunctional area or who has consent to research cooperation.
Key exclusion criteria
User: A person who stopped using small-scale multifunctional functions due to hospitalization or facility entry.
Volunteer: Person with suspected moderate or higher dementia.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Teraoka |
| Middle name | |
| Last name | Sawa |
Organization
Kyushu University
Division name
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6939
sawa317@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Teraoka |
| Middle name | |
| Last name | Sawa |
Organization
Kyushu University
Division name
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6939
Homepage URL
sawa317@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
JST
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
Center for Clinical and Translational Research(CCTR) of Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku Fukuoka
Tel
092-642-5774
tr-info@med.kyushu-u.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
| 2019 | Year | 12 | Month | 12 | 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
17
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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
