UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cognitive-behavioral counseling on patients with mild dementia
Acronym	Cognitive-behavioral counseling for patients with mild dementia
Scientific Title	Cognitive behavioral therapy for people with mild dementia
Scientific Title:Acronym	Counseling for people with mild dementia
Region	Japan

Condition
Condition	people with mild dementia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of counseling on patients with mild dementia. The greatest strength of research is that it can share real-life situations and be practiced in occupational therapy. The awareness and tasks derived from counseling are practiced in occupational therapy, and reflected and shared in counseling. Taking advantage of these strengths, we will practice it from the viewpoint of preventing the progression of dementia, and create a model of occupational therapy for patients with mild dementia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mini Mental State Examination-Japanese
Key secondary outcomes	Neuropsychiatric Inventory-Question Functional Independence Measure Clinical Dementia Rating Qualitative evaluation Counseling content 20 minutes 20 sessions

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Counseling intervention group First, quantitative evaluation (MMSE-J, NPI-Q, FIM, CDR-J) is evaluated, and a semi-structured interview using an interview guide is conducted. Occupational therapy is practiced based on the issues raised there, and counseling is provided as a reflection. At that time, we will look back using counseling notes, share the issues that have arisen, and practice in occupational therapy. After conducting this for 4 weeks, a semi-structured interview will be conducted as a final evaluation to hear the impressions during counseling.
Interventions/Control_2	Control group Quantitative evaluation (MMSE-J NPI-Q, FIM, CDR-J) is evaluated, and usual occupational therapy is performed. The usual occupational therapy mentioned here is training and environment setting for improving ADL, selection of self-help equipment and welfare equipment, cognitive function training and physical function training (walking) that are generally performed for dementia. (Strength training, etc.) Nursing care guidance for families.
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	70 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Disease aged 65 and over with the consent of the family Patients with Alzheimer's disease admitted to the hospital. Or suffer from cerebrovascular dementia, Lewy body dementias, frontotemporal dementia The duration of illness excludes those over 48 months CDR-J 0.5 to 1, MMSE-J 18 to 23 points.
Key exclusion criteria	impaired consciousness and delirium, and judgment is impaired. Utterance is at the word level and comprehension is at the short sentence level. Behavioral psychological symptoms (hereinafter referred to as BPSD) that cannot be evaluated
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Iwakiri Middle name Last name Ryouta
Organization	Nichinan Municipal Chubu Hospital
Division name	Rehabilitation center
Zip code	8893141
Address	2-5-10 Odotsu,Nichinan City, Miyazaki Prefecture
TEL	0987271182
Email	yoyoshi21@yahoo.co.jp

Public contact
Name of contact person	1st name Iwakiri Middle name Last name Ryouta
Organization	Nichinan Municipal Chubu Hospital
Division name	Rehabilitation center
Zip code	889-3141
Address	2-5-10 Odotsu Nichinan City Miyazaki Prefecture
TEL	0987271182
Homepage URL
Email	yoyoshi21@yahoo.co.jp

Sponsor
Institute	Nichinan Municipal Chubu Hospital
Institute
Department

Funding Source
Organization	No research funding organization
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	Nichinan Municipal Chubu Hospital
Address	2-5-10 Odotsu Nichinan City Miyazaki Prefecture
Tel	0987271182
Email	yoyoshi21@yahoo.co.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	日南市立中部病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	2020 Year 09 Month 02 Day
Date of IRB	2020 Year 09 Month 02 Day
Anticipated trial start date	2020 Year 09 Month 02 Day
Last follow-up date	2022 Year 06 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 02 Month 13 Day
Last modified on	2021 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049457

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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