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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045088
Receipt No. R000051507
Scientific Title A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Date of disclosure of the study information 2021/10/05
Last modified on 2021/10/05

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Basic information
Public title A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Acronym A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Scientific Title A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Scientific Title:Acronym A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine the feasibility of implementing an online cognitive behavioral therapy program for family caregivers of people with dementia.
Basic objectives2 Safety
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(8 weeks)
Key secondary outcomes 1.psychological variable of the family caregivers(HADS, HRQOL, DCPFS-21)

2.Behavioral and Psychological Symptoms of
Dementia(BPSD) in patients with dementia(NPI-Q)

Feasibility assessment
1.Dropout rate
2.Incidence of adverse events
3.Satisfaction with the program

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
Behavior,custom
Interventions/Control_1 An online CBT program (50 minutes x 8 sessions) will be conducted for family 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Those who aged between 20 and 80 years old
2.Those who have relatives with mild cognitive impairment (MCI) or symptoms of dementia.
3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading).
4.Those who can basically attend the program once a week via video conferencing system (WebEx, Zoom, etc.).
Key exclusion criteria 1.Those who have been declared to have a life expectancy of less than one year due to physical illness.
2.Those who are scheduled to be hospitalized for mental or physical illness.
3.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 Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email taji0808@gmail.com

Public contact
Name of contact person
1st name Miyuki
Middle name
Last name Tajima
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email taji0808@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Clinical and Translational Research Center
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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
2021 Year 10 Month 05 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 Preinitiation
Date of protocol fixation
2021 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 05 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 08 Month 07 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051507

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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