UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040890
Receipt number R000046686
Scientific Title Effectiveness and safety evaluation of online dementia medical care
Date of disclosure of the study information 2020/06/25
Last modified on 2023/12/28 09:55:17

* 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

Effectiveness and safety evaluation of dementia medical care using online medical care

Acronym

Effectiveness and safety evaluation of dementia medical care using online medical care

Scientific Title

Effectiveness and safety evaluation of online dementia medical care

Scientific Title:Acronym

Effectiveness and safety evaluation of online dementia medical care

Region

Japan


Condition

Condition

dementia

Classification by specialty

Neurology Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating the effectiveness and safety of online medical care for patients with dementia

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

The main endpoints in this study are measured at the start of the study (0 weeks), 24 weeks, and 48 weeks by the three-time evaluation Zarit care burden scale.

Key secondary outcomes

Cognitive function(MMSE), clinical dementia rating(CDR), questionnaire version Neuropsychiatric Inventory-Brief Questionnaire Form (NPI-Q), Geriatric depression scale 15 (GDS15) at the start of the study (0weeks), 24 weeks, 48weeks 3evaluations.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Face-to-face consultation period

Interventions/Control_2

online medical treatment combination 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

50 years-old <=

Age-upper limit

95 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who visit our memory clinic.
Patients with dementia or mild cognitive impairment between the ages of 50 and under 95.
Person who can determine that necessary inspection can be performed on the specified date after obtaining consent
Study partners have at least 7 hours of contact with the subject per week and can accompany all consultations during the observation period.
Person who obtained consent in writing from the research participant and study partner
Person who can use online medical care.

Key exclusion criteria

Person with a history of substance use disorder other than smoking or being treated
Person who has a history of epilepsy or is being treated
Persons receiving antidepressants, antipsychotics, hypnotics including long-term sleeping pills
Persons with a history of psychiatric/neurological disorders that affect cognitive function
Persons with serious complications

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Ito

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

1608582

Address

Tokyo

TEL

0353633788

Email

dito@keio.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ito

Organization

Keio University School of Medicine

Division name

Department of Neurology

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan

TEL

0353633788

Homepage URL


Email

dito@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan

Tel

0333531211

Email

keio@esct.bvits.com


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

2020 Year 06 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

13

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

No longer recruiting

Date of protocol fixation

2020 Year 06 Month 25 Day

Date of IRB

2020 Year 06 Month 22 Day

Anticipated trial start date

2020 Year 06 Month 30 Day

Last follow-up date

2023 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

2020 Year 06 Month 25 Day

Last modified on

2023 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name