UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051996
Receipt number R000059341
Scientific Title Effects of memory recall of hard-working episodes on reminicense quality in community-dwelling older adults: a randomized controlled trial
Date of disclosure of the study information 2023/08/31
Last modified on 2023/11/20 09:23:00

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Basic information

Public title

Effects of memory recall of hard-working episodes on reminicense quality in community-dwelling older adults: a randomized controlled trial

Acronym

Effects of memory recall of hard-working episodes on reminicense quality

Scientific Title

Effects of memory recall of hard-working episodes on reminicense quality in community-dwelling older adults: a randomized controlled trial

Scientific Title:Acronym

Effects of memory recall of hard-working episodes on reminicense quality in community-dwelling older adults: a randomized controlled trial

Region

Japan


Condition

Condition

Older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine whether memory-based recall of pleasant experiences or memory-based recall of hard work is more effective in promoting positive recall tendencies (quality of recall) associated with the prevention or reduction of depression in older adults living in the community.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive and Negative Reminiscence Scale

Key secondary outcomes

Geriatric Depression scale15; Life Satisfaction Index Z


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Recollections due to past events of hard work

Interventions/Control_2

Recollections based on pleasant past events

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Older adults over 65 years old. Able to communicate with others. Able to communicate with others, and who have agreed to cooperate in the research.

Key exclusion criteria

Those who have been diagnosed with dementia. The respondents who have difficulty in understanding the questions on the survey form and are unable to answer the questions on their own. Persons with severe visual or hearing impairment.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Kyosuke
Middle name
Last name Yorozuya

Organization

Seijoh University

Division name

Faculty of Rehabilitation and Care

Zip code

476-8588

Address

2-172 Fukinodai, Tokai, Aichi

TEL

0526016000

Email

yorozuya@seijoh-u.ac.jp


Public contact

Name of contact person

1st name Kyosuke
Middle name
Last name Yorozuya

Organization

Seijoh University

Division name

Faculty of Rehabilitation and Care

Zip code

476-8588

Address

2-172 Fukinodai, Tokai, Aichi

TEL

0526016000

Homepage URL


Email

yorozuya@seijoh-u.ac.jp


Sponsor or person

Institute

Seijoh University

Institute

Department

Personal name

Kyosuke Yorozuya


Funding Source

Organization

Seijoh University

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

The Research Ethics Committee of Seijoh University

Address

2-172 Fukinodai, Tokai, Aichi

Tel

0526016000

Email

tsutsui@seijoh-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

2023 Year 08 Month 31 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

26

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

2023 Year 06 Month 23 Day

Date of IRB

2023 Year 04 Month 10 Day

Anticipated trial start date

2023 Year 08 Month 31 Day

Last follow-up date

2023 Year 09 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 08 Month 24 Day

Last modified on

2023 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059341