UMIN-CTR Clinical Trial

Basic information
Public title	Factors related to individual reminiscence therapy for elderly with dementia and cognitive functions
Acronym	Factors related to individual reminiscence therapy for elderly with dementia and cognitive functions
Scientific Title	Factors related to individual reminiscence therapy for elderly with dementia and cognitive functions
Scientific Title:Acronym	Factors related to individual reminiscence therapy for elderly with dementia and cognitive functions
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This will include 30 elderly with dementia divided into the experimental and the control group. Participants will receive reminiscence therapy individually. The effects of the individual interventions for the elderly with dementia will be investigated by evaluating their cognitive and mental functions between before and after the implementation of interventions. This will help elderly with dementia in care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mini mental state examination(MMSE)
Key secondary outcomes	Philadelphia Geriatric Center Morale Scale, Multidimentional Observation Scale for Elderly Subjects (MOSES), Trail making test, Word Fluency Test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Patients will receive eight sessions of reminiscence therapy individually.
Interventions/Control_2	Patients will receive eight sessions of reminiscence therapy individually.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Elderly of 65 years or more, with the formal diagnosis of dementia(Alzheimer's disease and vascular dementia) or mild cognitive impairment 2. Able to answer closed questions 3. Able to look at pictures and watch short movies for 30 minutes
Key exclusion criteria	1. Elderly without the formal diagnosis of dementia 2. Patients with severe hearing difficulties 3. Patients with problems in communication 4. Disable to look at pictures and short movies for 30 minutes 5. Continuous health problems
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Ayae Middle name Last name Kinoshita
Organization	Graduate School of Medicine Kyoto university
Division name	Human Health Sciences
Zip code	606-8397
Address	53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4300
Email	kinoshita.ayae.6v@kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Maho Middle name Last name Tominari
Organization	Graduate School of Medicine Kyoto university
Division name	Human Health Sciences
Zip code	606-8397
Address	53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-753-4300
Homepage URL
Email	tominari.maho.43m@st.kyoto-u.ac.jp

Sponsor
Institute	Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Kyoto University
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	Kyoto University Graduate school of Medicine Ethics Committe
Address	54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto, Japan
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	52
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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 19 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 28 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034949