UMIN-CTR Clinical Trial

Basic information
Public title	The effects of reminiscence practice on care prevention in community-dwelling elderly people
Acronym	The effects of reminiscence practice in community-dwelling elderly people
Scientific Title	The effects of reminiscence practice on care prevention in community-dwelling elderly people
Scientific Title:Acronym	The effects of reminiscence practice in community-dwelling elderly people
Region	Japan

Condition
Condition	Community-dwelling elderly people
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Community-dwelling elderly people are randomly put into an intervention group or a control group. In the intervention group, reminiscence is carried out using olfactory stimulation. In the control group, reminiscence is carried out using word cards. The purpose of this research is to determine the effectiveness of olfactory stimulation in reminiscence intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Geriatric Depression Scale-15 Evaluations were performed at two points; baseline and after intervention.
Key secondary outcomes	Five Cognitive Test Evaluations were performed at two points; baseline and after intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Intervention Group: Reminiscence is carried out weekly using olfactory stimulation as the reminiscence cue for twelve sessions (40 min).
Interventions/Control_2	Control Group: Reminiscence is carried out weekly using word cards as the reminiscence cue for twelve sessions (40 min).
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects over 65 years of age 2. Subjects living in the community 3. Subjects who are able to attend without any help 4. Subjects that provided informed consent
Key exclusion criteria	1. Subjects under long-term care insurance 2. Subjects with smell disorders 3. Subjects who have problems with hearing, vison, or language in group activities 4. Subjects who are assessed by the principal investigator or primary doctor due to other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideaki Hanaoka
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5400
Email	hhanaoka@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shingo Yamane
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5417
Homepage URL
Email	shingoyamane@hiroshima-u.ac.jp

Sponsor
Institute	Graduate School of Biomedical & Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 04 Month 01 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	2018 Year 03 Month 08 Day
Date of IRB	2018 Year 02 Month 06 Day
Anticipated trial start date	2018 Year 05 Month 14 Day
Last follow-up date	2019 Year 01 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	2018 Year 03 Month 13 Day
Last modified on	2020 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036206