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

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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 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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name