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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030271
Receipt No. R000034563
Scientific Title A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Date of disclosure of the study information 2019/03/31
Last modified on 2019/06/08

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Basic information
Public title A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Acronym A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Scientific Title A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Scientific Title:Acronym A forward search exploratory study on the validity and effectiveness of group therapy program for family caregivers of elderly with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploratory study of effective method of psychoeducation program for family caregivers of elderly with dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire survey on the contents of psychoeducational programs of high interest to family caregivers
Evaluate when psychoeducational education program is implemented for the first time and last time.
Key secondary outcomes Zarit Care-Giver Burden Interview, NPI - Q (Neuropsychiatric Inventory - Questionnaire) Japanese version, Self-rating Depression Scale.
Evaluate when psychoeducational education program is implemented for the first time and last time.

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
Other
Interventions/Control_1 Doctor, clinical psychologist, occupational therapist, physical therapist, nutritionist, social worker, nurse perform psychoeducational education program for family caregivers of elderly with dementia. The psychology education program is conducted twice a month, and it is carried out six times in total. It is 1 hour 30 minutes once.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Learners of psychoeducational programs for family caregivers of elderly people with dementia at Kitasato University East Hospital psychiatry department
Key exclusion criteria Those who do not have adequate attendance rates for psychoeducational programs
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Miyaoka
Organization Kitasato University of Medicine
Division name psychiatry
Zip code 252-0380
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara-City, Kanagawa Prefecture, Japan
TEL 042-748-9111
Email miyaoka@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name Kyou
Organization Kitasato University Graduate School
Division name Medical Sciences
Zip code 252-0375
Address 1-15-1 Kitasato Minami-ku, Sagamihara-city, Kanagawa prefecture, Japan
TEL 042-778-9305
Homepage URL
Email kyouyoshitaka@gmail.com

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University Hospital Ethics Office
Address 1-15-1 Kitasato Minami-ku, Sagamihara-city, Kanagawa prefecture, Japan
Tel 042-778-8273
Email rinrib@med.kitasato-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
2019 Year 03 Month 31 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
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
2017 Year 12 Month 05 Day
Date of IRB
2018 Year 03 Month 27 Day
Anticipated trial start date
2017 Year 12 Month 05 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2019 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034563

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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