UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024158 |
|---|---|
| Receipt number | R000027817 |
| Scientific Title | The investigation and intervention of both social isolation and self management ability for MCI and dementia patients and their caregivers |
| Date of disclosure of the study information | 2016/09/25 |
| Last modified on | 2021/05/03 16:44:46 |
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Basic information
Public title
The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers
Acronym
The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients
Scientific Title
The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers
Scientific Title:Acronym
The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients
Region
| Japan |
Condition
Condition
MCI , Dementia patients
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate both social isolation and self management ability for MCI and dementia patients and their caregivers, and establish effective intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social support questionnaire,
Coping questionnaire
Key secondary outcomes
Zarit Caregiver Burden Interview (ZBI)
Mini-Mental State Examination (MMSE)
Neuropsychiatry inventory (NPI)
Quality of Life-Alzheimer's disease(QOL-AD)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom | Maneuver |
Interventions/Control_1
intervention therapy for caregivers
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the chief caregiver of MCI and dementia patients, reliable informed consent could be obtained from the patient and or his her relatives
Key exclusion criteria
There was a previous history of mental illness, other findings in terms with the aims of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Yagoto hospital
Division name
Psychiatry
Zip code
468 00073
Address
1-403 Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL
052-832-2111
junko-sa@seirei.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Yagoto hospital
Division name
Psychiatry
Zip code
368-0073
Address
Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL
052-832-2111
Homepage URL
junko-sa@seirei.ac.jp
Sponsor or person
Institute
Yagoto hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Yagoto
Address
Yagoto
Tel
052-832-2111
hisyo@yagotohp.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
資生会 八事病院 (愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
we can not commplete analysis
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
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027817
