UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043320 |
|---|---|
| Receipt number | 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 23:46:17 |
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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
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
yoyoshi21@yahoo.co.jp
Sponsor or person
Institute
Nichinan Municipal Chubu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049457
