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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033697
Receipt No. R000038423
Official scientific title of the study Measuring the effects of group education on families of people with dementia
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/09

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Basic information
Official scientific title of the study Measuring the effects of group education on families of people with dementia
Title of the study (Brief title) Measuring the effects of group education on families of people with dementia
Region
Japan

Condition
Condition Family caregivers of people with dementia
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and to put into practice disease education and psychotherapy program targeting caregivers of people with dementia. To collect basic data on the effect of the program on participants and lead to an improvement of the program and a new study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Depressive symptoms of family caregivers of people with dementia(PHQ-9)
Key secondary outcomes Effectiveness Evaluation
1. care burden on the family caregivers(ZBI-J)
2. psychological variable of the family caregivers(QOL)
3. Behavioral and Psychological Symptoms of Dementia(BPSD) in patients with dementia(NPI-Q)

Feasibility Evaluation
1. Drop out rate
2. Adverse event rate

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
Maneuver
Interventions/Control_1 Group program(90 minutes, 5 sessions)
Contents of the program; psychoeducation about dementia, caregiver stress and the way of managing it, cognitive behavioral therapy, the way of utilizing social resources, the way of communicating with people with dementia.
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 1.Those who aged between 20 and 89, inclusive.
2.Those who spend their time with families diagnosed with dementia more than ten hours a week.
3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading).
Key exclusion criteria 1.Those who score 23 points or less of MMSE.
2.Those who are diagnosed with schizophrenia, substance use disorder, or organic mental disorder.
3.Those who are given less than one year to live due to cancer or other diseases.
4.Those who are deemed to have difficulty in participating by the researcher due to other reasons.
Target sample size 50

Research contact person
Name of lead principal investigator Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Address 4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL 042-341-2712
Email mtajima@ncnp.go.jp

Public contact
Name of contact person Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Address 4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL 042-341-2712
Homepage URL
Email mtajima@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization intramural research grant for neurological and psychiatric disorders of NCNP

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

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 08 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 08 Month 28 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038423

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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