UMIN-CTR Clinical Trial

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

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	Enrolling by invitation
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	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.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

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