UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024158
Receipt number R000027817
Scientific Title The investigation and intervention of both social isolation and self management ability for MCI and dementia patients and their caregivers
Date of disclosure of the study information 2016/09/25
Last modified on 2021/05/03 16:44:46

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Basic information

Public title

The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers

Acronym

The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients

Scientific Title

The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers

Scientific Title:Acronym

The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients

Region

Japan


Condition

Condition

MCI , Dementia patients

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aimed to evaluate both social isolation and self management ability for MCI and dementia patients and their caregivers, and establish effective intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Social support questionnaire,
Coping questionnaire

Key secondary outcomes

Zarit Caregiver Burden Interview (ZBI)
Mini-Mental State Examination (MMSE)
Neuropsychiatry inventory (NPI)
Quality of Life-Alzheimer's disease(QOL-AD)


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

Medicine Behavior,custom Maneuver

Interventions/Control_1

intervention therapy for 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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

the chief caregiver of MCI and dementia patients, reliable informed consent could be obtained from the patient and or his her relatives

Key exclusion criteria

There was a previous history of mental illness, other findings in terms with the aims of this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Junko
Middle name
Last name Sato

Organization

Yagoto hospital

Division name

Psychiatry

Zip code

468 00073

Address

1-403 Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan

TEL

052-832-2111

Email

junko-sa@seirei.ac.jp


Public contact

Name of contact person

1st name Junko
Middle name
Last name Sato

Organization

Yagoto hospital

Division name

Psychiatry

Zip code

368-0073

Address

Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan

TEL

052-832-2111

Homepage URL


Email

junko-sa@seirei.ac.jp


Sponsor or person

Institute

Yagoto hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Yagoto

Address

Yagoto

Tel

052-832-2111

Email

hisyo@yagotohp.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

資生会 八事病院 (愛知県)


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 25 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

20

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

we can not commplete analysis

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

Completed

Date of protocol fixation

2016 Year 08 Month 31 Day

Date of IRB

2016 Year 09 Month 25 Day

Anticipated trial start date

2016 Year 09 Month 25 Day

Last follow-up date

2018 Year 03 Month 28 Day

Date of closure to data entry

2018 Year 03 Month 28 Day

Date trial data considered complete

2018 Year 03 Month 28 Day

Date analysis concluded

2018 Year 03 Month 28 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 25 Day

Last modified on

2021 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name