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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031496
Receipt No. R000035943
Scientific Title Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/27

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Basic information
Public title Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Acronym Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Scientific Title Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Scientific Title:Acronym Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect of the CBT program delivered by visiting nurses on their home nursing visits, using before and after study targeting family caregivers of people with dementia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The burden experienced by family caregivers after the end of the intervention(12 weeks)
Key secondary outcomes Effectiveness Evaluation
1.care burden on the family caregivers(ZBI-J)
2.psychological variable of the family caregivers(HADS HRQOL, Brief COPE, SWL)
3.Behavioral and Psychological Symptoms of Dementia(BPSD) in patients with dementia(NPI-Q)

Feasibility Evaluation
1. Drop out rate
2. Adverse event rate
3. Level of satisfaction with the program(CSQ-8)

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 Visting nurses deliver the CBT program(30minutes,11 sessions) on their home nursing visits.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Those who aged between 20 and 79, 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).
4.Those who can attend the program once a week basically.
Key exclusion criteria 1.Those who score 23 points or less of MMSE (measured when aged 60 or over).
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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code
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
1st name
Middle name
Last name Miyuki Tajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035943

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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