UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031496 |
|---|---|
| Receipt number | 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 | 2020/03/04 10:36:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL
042-341-2712
mtajima@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL
042-341-2712
Homepage URL
mtajima@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel
042-341-2712
rinri-jimu@ncnp.go.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 | 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
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035943
