UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of a novel tablet computer software for memory impairment of brain-damaged patients: a randomized controlled study.
Acronym	Usefulness of a novel tablet computer software for people with memory deficit : a randomized controlled study.
Scientific Title	Usefulness of a novel tablet computer software for memory impairment : a randomized controlled study.
Scientific Title:Acronym	Usefulness of a novel tablet computer software for people with memory deficit : a randomized controlled study.
Region	Japan

Condition
Condition	Brain-damaged
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine if the Information and communication technology(ICT) tool that was developed for external memory compensation can improve memory function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Everyday Memory Checklist(EMC)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	We used permuted variable block randomization for four strata. Intervention After a two-week training period, the subjects of the intervention group used the ICT tool for three months.
Interventions/Control_2	Control The control group patients were placed on the waiting list for three months, while undergoing the same test procedures as the intervention group. they use ICT after three months.
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	16 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Conitive disabilities after acquired brain injury. 2.Those with subjective memory impairment in daily life or at work. 3.One of the following neuropsychological parameters below the cut-off point. 4.At least 6 months after brain damage onset, and currently out of the hospital. 5.Those who can utilize the basic function of a tablet computer.
Key exclusion criteria	Psychiatric or neurologic disease prior to brain injury.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Rumi Middle name Last name Tanemura
Organization	Kobe University
Division name	Health Sciences
Zip code	654-0142
Address	tomogaoka,
TEL	0787964509
Email	rumtan@people.kobe-u.ac.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Ishida
Organization	Kobe University
Division name	Health Sciences
Zip code	654-0142
Address	tomogaoka,
TEL	0787964509
Homepage URL
Email	ishidakoma@kfy.biglobe.ne.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Labour and Welfare
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	Kobe University, graduate school of Health Sciences, Ethics Committee
Address	7-10-2 tomogaoka, Suma-ku,Kobe-city,Hyogo,Japan.
Tel	0787964502
Email	m-ito@people.kobe-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	2020 Year 10 Month 16 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	78
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	2015 Year 08 Month 30 Day
Date of IRB	2016 Year 02 Month 12 Day
Anticipated trial start date	2016 Year 02 Month 12 Day
Last follow-up date	2021 Year 03 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	2020 Year 10 Month 16 Day
Last modified on	2020 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048090