UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054305
Receipt number R000062029
Scientific Title Effects of Participation in Collaborative Projects with Older Adults on the Attitudes of Participants, and on the Self-efficacy and Cognitive Function of Older Adults
Date of disclosure of the study information 2024/05/02
Last modified on 2024/11/02 09:29:39

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Basic information

Public title

Effects of Participation in Collaborative Projects with Older Adults on the Attitudes of Participants, and on the Self-efficacy and Cognitive Function of Older Adults

Acronym

Effects of Participation in Collaborative Projects on the Young and Older Adults

Scientific Title

Effects of Participation in Collaborative Projects with Older Adults on the Attitudes of Participants, and on the Self-efficacy and Cognitive Function of Older Adults

Scientific Title:Acronym

Effects of Participation in Collaborative Projects on the Young and Older Adults

Region

Japan


Condition

Condition

Older adults, Physical disability, Mental disability, Mild cognitive impairment, Dementia

Classification by specialty

Medicine in general Neurology Psychosomatic Internal Medicine
Geriatrics Psychiatry Orthopedics
Neurosurgery Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of the collaborative project with older and healthy young adults on the participants' attitudes and the self-efficacy and cognitive function of older adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Participants attitudes

Key secondary outcomes

Self-efficacy, feeling of social connectedness, and cognitive function in older adults


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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

collaborative project with older adults (Gardening, etc.)

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy young adults
Older adults with or without disabilities

Key exclusion criteria

Nothing

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Mika
Middle name
Last name Otsuki

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

0600812

Address

Kita 12, Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan

TEL

011-706-3376

Email

lasteroideb612@pop.med.hokudai.ac.jp


Public contact

Name of contact person

1st name Mika
Middle name
Last name Otsuki

Organization

Hokkaido University

Division name

Faculty of Health Sciences

Zip code

0600812

Address

Kita 12, Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan

TEL

011-706-3376

Homepage URL


Email

lasteroideb612@pop.med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name

Mika Otsuki


Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University

Address

Kita 12, Nishi 5, Kita-Ku, Sapporo, Hokkaido, Japan

Tel

011-706-3315

Email

shomu@hs.hokudai.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

2024 Year 05 Month 02 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

35

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

No longer recruiting

Date of protocol fixation

2024 Year 05 Month 01 Day

Date of IRB

2024 Year 05 Month 01 Day

Anticipated trial start date

2024 Year 05 Month 15 Day

Last follow-up date

2025 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

2024 Year 05 Month 02 Day

Last modified on

2024 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062029