UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010325
Receipt number R000012086
Scientific Title A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people
Date of disclosure of the study information 2013/03/27
Last modified on 2015/03/02 11:58:33

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Basic information

Public title

A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people

Acronym

Preventive Home Visits: Hokkaido Study 3

Scientific Title

A Randomized Controlled Trial of a Functioning Improved Tool home visit program for Japanese frail older people

Scientific Title:Acronym

Preventive Home Visits: Hokkaido Study 3

Region

Japan


Condition

Condition

Dementia
Depression
Disuse syndrome

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effects of a Functional Improvement Tool home visit program for older people

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

cognitive function

Key secondary outcomes

Depressive status
Activities of Daily Living


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Functioning Improvement Tool home visit program

Interventions/Control_2

Home visits that included general conversations

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

65 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Living at Takikawa city, Hokkaio, Japan
2. Frail elderly according to Japan Long Term Care system
3. Single or couple households

Key exclusion criteria

Mini-Mental State Examination score: <18

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigekazu Ukawa

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Public Health

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638

TEL

+81-11-706-5068

Email

s-ukawa@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigekazu Ukawa

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Public Health

Zip code


Address

Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638

TEL

+81-11-706-5068

Homepage URL


Email

s-ukawa@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

NIPPONKOA WELFARE FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

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

2013 Year 03 Month 27 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

Completed

Date of protocol fixation

2013 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 08 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

2013 Year 03 Month 27 Day

Last modified on

2015 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name