UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034260
Receipt number R000039055
Scientific Title Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members
Date of disclosure of the study information 2018/09/25
Last modified on 2018/11/20 11:01:17

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Basic information

Public title

Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members

Acronym

Research on self-management support for persons with dementia or MCI, and their families

Scientific Title

Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members

Scientific Title:Acronym

Research on self-management support for persons with dementia or MCI, and their families

Region

Japan


Condition

Condition

Alzheimer's disease dementia, Mild cognitive impariment

Classification by specialty

Geriatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To propose an empowerment intervention for persons with early-stage Alzheimer's disease dementia or Mild cognitive impairment, and their family members after diagnosis, and to verify the efficacy of the intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Sense of Coherence Scale (SOC-13)
(after the 10-week interventions)

Key secondary outcomes

Japanese version of WHO-Five well-being index
Japanese version of Multidimensional Scale of Perceived Social Support
Japanese version of Herth Hope Index
Japanese version of the Gratitude Questionnaire
Japanese version of the UCLA Loneliness Scale Version 3
Japanese version of NPI (Neuropsychiatric Inventory) -Q
The short version of the Japanese version of the Zarit Burden Interview (J-ZBI_8).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Weekly one-hour interventions of the group meetings of the patients and their family members at the National Center for Geriatrics and Gerontology.
Home work done by the patients and their family members during the intervention period.

Interventions/Control_2

Home work done by the patients and their family members during the intervention period.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

-Patients diagnosed as mild cognitive impairment due to Alzheimer's disease or Alzheimer's disease dementia.
-Total scores of Mini-Mental Scale Examination (MMSE): 20 or more
-Possible to communicate in language.
-Patients who can attend the intervention with the main caregivers.

Key exclusion criteria

-Patients diagnosed as mild cognitive impairment due to Lewy Body Disease, or Frontotemporal Dementia.
-Patients diagnosed as psychiatric diseases other than mild cognitive disease or dementia.
-Difficult to communicate in language (e.g., aphasia)

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yohko Maki

Organization

National Center for Geriatrics and Gerontology

Division name

Education and Innovation Center

Zip code


Address

7-430, Morioka, Obu, Aichi 474-8511 Japan

TEL

0562-46-2311

Email

maki-yk@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yohko Maki

Organization

National Center for Geriatrics and Gerontology

Division name

Education and Innovation Center

Zip code


Address

7-430, Morioka, Obu, Aichi 474-8511 Japan

TEL

0562-46-2311

Homepage URL


Email

maki-yk@umin.ac.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

National Center for Geriatrics and Gerontology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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 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


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

2018 Year 07 Month 08 Day

Date of IRB


Anticipated trial start date

2018 Year 11 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 09 Month 25 Day

Last modified on

2018 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039055


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name