UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040388
Receipt number R000046088
Scientific Title A study on risk stratification of chronic diseases (hypertension, diabetes, arteriosclerosis) in users of welfare facilities for persons with disabilities and chronic disease management program for high-risk groups
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/13 18:17:39

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Basic information

Public title

A study on chronic disease management program for users of welfare facilities for persons with disabilities

Acronym

A study on chronic disease management program for users of welfare facilities for persons with disabilities

Scientific Title

A study on risk stratification of chronic diseases (hypertension, diabetes, arteriosclerosis) in users of welfare facilities for persons with disabilities and chronic disease management program for high-risk groups

Scientific Title:Acronym

A study on risk stratification of chronic diseases in users of welfare facilities for persons with disabilities and chronic disease management program for high-risk groups

Region

Japan


Condition

Condition

Nursing

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to stratify the risk of chronic diseases (hypertension, diabetes, arteriosclerosis) for persons with disabilities in welfare facilities, and implement a chronic disease management program for high-risk groups. It is to verify the effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Achievement rate (diet therapy, exercise therapy, medication compliance, smoking, drinking)

Key secondary outcomes

Blood pressure
Complication of heart disease and cerebrovascular disease
Blood sugar level (fasting, 2 hours after meal)
Development of diabetic complications
Measurement of arteriosclerosis
Progression of arteriosclerosis weight, BMI, waist circumference
Urinalysis (urine sugar)
Number of hospitalizations
Type and amount of drug
QOL scale score (SF-8)
Degree of forgetting to take medication
Number of visits / rate
Social support


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

One chronic disease management program for users of welfare facilities
Biweekly for six months, total twelve times

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects are men and women between the ages of 20 and 75, and those with disabilities (neurocognitive disorders, intellectual disability, mental disorders) attending welfare facilities for persons with disabilities and those who have consented to participate in the study

Key exclusion criteria

Exclude any of the following cases.
Those who cannot communicate
Those who cannot answer questions due to disabilities or mental illness
Person who did not get consent from the legal representative (family or agent)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Nozomi
Middle name
Last name Takayama

Organization

Hokkaido University

Division name

Faculty of Health Science

Zip code

060-0812

Address

five, Nishi, Kita-ku, Sapporo-shi, Hokkaido, Japan

TEL

070-3875-3714

Email

harvester.20101001@gmail.com


Public contact

Name of contact person

1st name Nozomi
Middle name
Last name Takayama

Organization

Hokkaido University

Division name

Faculty of Health Science

Zip code

060-0812

Address

five, Nishi, Kita-ku, Sapporo-shi, Hokkaido, Japan

TEL

070-3875-3714

Homepage URL


Email

harvester.20101001@gmail.com


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hokkaido University of Science

Name of secondary funder(s)

Nursing Consultant harvester


IRB Contact (For public release)

Organization

Faculty of Health Science, Hokkaido University

Address

five, Nishi, Kita-ku, Sapporo-shi, Hokkaido, Japan

Tel

090-6216-2084

Email

harvester.20101001@gmail.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 05 Month 15 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

2020 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 05 Month 15 Day

Last follow-up date

2022 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 05 Month 13 Day

Last modified on

2020 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046088


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name