UMIN-CTR Clinical Trial

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
Institute	Hokkaido University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046088