UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043604
Receipt number R000049787
Scientific Title Effects of Color Narrative in Japanese community-dwelling older adults: a randomized controlled trial
Date of disclosure of the study information 2021/04/01
Last modified on 2022/09/12 21:18:33

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Basic information

Public title

Developing a brain-training program through an active life

Acronym

Developing a brain-training program through an active life

Scientific Title

Effects of Color Narrative in Japanese community-dwelling older adults: a randomized controlled trial

Scientific Title:Acronym

Effects of Color Narrative in older adults

Region

Japan


Condition

Condition

Healthy older people or older people with mild frailty who live in community

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effects of Color Narrative, a program of planning and execution type using knowledge about occupations, on cognitive functions, activity/participation, and subjective well-being by comparing it with conventional intervention programs of task performance type.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Cognitive functions
- Mini-Mental State Examination-Japanese
- Digit Span and Tapping Span (Clinical Assessment for Attention)
- Symbol Search (Wechsler Adult Intelligence Scale Fourth Edition)
- Wisconsin Card Sorting Test
(*at 6 and 12 months after the start of the interventions)

Key secondary outcomes

1) Status of activities and participation
- Japanese version of the FRAIL scale
- Self-Rating Frenchay Activities Index
2) Subjective well-being
- MOS 12-Item Short-Form Health Survey Version 2
- The Japanese version of the Life Engagement Test
- The Japanese version of the Meaning in Life Questionnaire-Short Form
(*at 6 and 12 months after the start of the interventions)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

"Phase 1: building a communal horizon of understanding"
An intervener participates in the participants' community groups one or two times only as a member.
"Phase 2: color-mediated occupational storytelling and setting occupational goals in groups"
A group work (about 90 minutes) using 100 color cards is performed. Participants recall their life histories related to their occupations using colors as clues, and they talk with each other. Next, they identify the occupations through which they believe they can improve their own lives, and set them as an occupational goal (about 30 minutes).
"Phase 3: individually occupational story making"
The occupational goals set by the participants at the previous phase should be carried out in their daily lives for about two months.
"Phase 4: reflecting on phase 3 and updating goals"
Through the group work, the individual process of their occupational story making (phase 3) is recalled (about 90 minutes). Afterwards, their occupational goals are updated with orienting their future life (about 30 minutes).

Interventions/Control_2

Expert lectures and exercises on frailty prevention (about 30 minutes), recreation (about 60 minutes), and conversation (about 30 minutes) are conducted two times at the same time as the phase 2 and phase 4 of the intervention 1 group.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Those who are members of a community group for older adults and regularly participate in the group, 2) those who can come to the venue by themselves, and 3) those who can communicate in Japanese.

Key exclusion criteria

1) Hospitalized patients, and 2) patients who have been diagnosed with dementia.

Target sample size

46


Research contact person

Name of lead principal investigator

1st name Risa
Middle name
Last name Takashima

Organization

Hokkaido University

Division name

Department of Rehabilitation Science, Faculty of Health Sciences

Zip code

060-0812

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

TEL

0117063380

Email

risa-t@hs.hokudai.ac.jp


Public contact

Name of contact person

1st name Risa
Middle name
Last name Takashima

Organization

Hokkaido University

Division name

Department of Rehabilitation Science, Faculty of Health Sciences

Zip code

060-0812

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

TEL

0117063380

Homepage URL


Email

risa-t@hs.hokudai.ac.jp


Sponsor or person

Institute

Department of Rehabilitation Science, Faculty of Health Sciences, Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

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

Faculty of Health Sciences, Hokkaido University

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

Tel

0117063315

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

地域の公共の会館や施設/Public halls and facilities in community


Other administrative information

Date of disclosure of the study information

2021 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

No longer recruiting

Date of protocol fixation

2021 Year 03 Month 12 Day

Date of IRB

2021 Year 03 Month 31 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2023 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 12 Day

Last modified on

2022 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name