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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043320
Receipt No. R000049457
Scientific Title Cognitive behavioral therapy for people with mild dementia
Date of disclosure of the study information 2021/02/13
Last modified on 2021/02/13

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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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