UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030604 |
|---|---|
| Receipt number | R000034949 |
| Scientific Title | Factors related to individual reminiscence therapy for elderly with dementia and cognitive functions |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/29 23:59:07 |
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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
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
kinoshita.ayae.6v@kyoto-u.ac.jp
Public contact
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
tominari.maho.43m@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034949
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
