UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031701
Receipt number R000036206
Scientific Title The effects of reminiscence practice on care prevention in community-dwelling elderly people
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/20 14:17:56

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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 or person

Institute

Graduate School of Biomedical & Health Sciences, Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036206


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name