UMIN-CTR Clinical Trial

Public title

Screening of cardiovascular, cerebrovascular, and renal disease for residents in rural areas using a medical IT network

Acronym

Screening of disease for residents in rural areas using a medical IT network

Scientific Title

Screening of cardiovascular, cerebrovascular, and renal disease for residents in rural areas using a medical IT network

Scientific Title:Acronym

Screening of disease for residents in rural areas using a medical IT network

Region

Japan

Condition

cardiovascular disease, cerebrovascular disease, renal disease

Classification by specialty

Cardiology	Nephrology	Neurology
Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To formulate the guideline to improve prognosis of residents in rural areas by intervention by specialists via medical information network

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The difference of incidence of cardiovascular, cerebrovascular, or renal diseases between residents in rural areas with intervention by specialists via the medical information network and those without the intervention.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Other

Interventions/Control_1

Intervention group gets advices from specialists in Sendai area via medical information network.

Interventions/Control_2

Non-intervention group is followed up by doctors in each area.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Men and women living in other than Sendai area aged 65 years or over with low or middle risk for cardiovascular diseases determined by existing guidelines

Key exclusion criteria

-Patients with history of stroke, myocardial infarction, or severe cardiovascular diseases within six month
-BNP is 200pg/mL or over
-eGFR is less than 30mL/min/1.73m2 or albumin creatinine ratio in urin is 300mg/gCr or over
-Patient ineligible to this study due to other medical reasons

Target sample size

1000

Name of lead principal investigator

1st name	Masaharu
Middle name
Last name	Nakayama

Organization

Tohoku University

Division name

Department of Medical Informatics, Tohoku University School of Medicine

Zip code

980-8575

Address

2-1, Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

022-717-7572

Email

nakayama@cardio.med.tohoku.ac.jp

Name of contact person

1st name	Masaharu
Middle name
Last name	Nakayama

Organization

Tohoku University

Division name

Department of Medical Informatics, Tohoku University School of Medicine

Zip code

980-8575

Address

2-1, Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

022-717-7572

Homepage URL

Email

nakayama@cardio.med.tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Akita University

Name of secondary funder(s)

Organization

Ethics Committee of Tohoku University School of Medicine

Address

2-1, Seiryo-machi, Aoba-ku, Sendai, Japan

Tel

022-728-4105

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

05

Day

URL releasing protocol

https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000018552

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34107543/

Number of participants that the trial has enrolled

1092

Results

1029 subjects living in the rural areas were randomly assigned to an intervention group in which general practitioners (GPs) were advised by specialists through health information exchange or a control group in which GPs received no advice. All-cause mortality and cumulative incidence of serious adverse events did not differ between the groups. However, per-protocol analysis controlling for GP adherence with specialist recommendations revealed significantly reduced them in the intervention group.

Results date posted

2023

Year

08

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We evaluated the clinical data of 1,092 patients aged >=65 years living in the rural areas of the Miyagi Prefecture and receiving care from general practitioners (GPs) only. Low-to-moderate risk patients were randomly assigned to an intervention group in which GPs were advised by specialists through health information exchange (n = 518, 38% male, mean age = 76 +/- 7 years) or a control group in which GPs received no advice by specialists (n = 521, 39% male, mean age = 75 +/- 7 years).

Participant flow

A total of 1,090 patients were enrolled from November 2015 to September 2016 (39% men, mean age = 76 +/- 7 years, range = 65-94 years). Fifty-one high-risk patients were immediately referred to specialists. Simple randomization was used to assign low-to-moderate risk patients to either the intervention group or control group. The assignment was disclosed to the enrolled patients. The 1,039 patients with low-to-moderate risk were then randomly assigned to an intervention group (n = 518, 38% men, mean age = 76 +/- 7 years) or a usual care (control) group (n = 521, 39% men, mean age = 75 +/- 7 years). In the intervention group, specialists evaluated each participant's risk and provided recommendations to the general practitioner, who then decided whether to alter the treatment strategy. However, 6 months after the first recommendation, specialists provided additional comments to the general practitioners. We conducted follow-up assessments at 6 months and 1 year to evaluate general practitioner's adherence to recommendations and current risks among patients.

Adverse events

None.

Outcome measures

The difference of incidence of cardiovascular, cerebrovascular, or renal diseases between residents in rural areas with intervention by specialists via the medical information network and those without the intervention.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2015

Year

06

Month

25

Day

Date of IRB

2015

Year

10

Month

01

Day

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients meeting exclusion criteria are not included in the intervention trial, and they are included in the observational study. The patients at high risk are encouraged to visit specialists at the beginning of observation. The subjects are followed up after six month, and if they do not visit specialists, they are encouraged to visit specialists again. They are followed up after one year, and data on outcome are collected.

Registered date

2015

Year

08

Month

05

Day

Last modified on

2023

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020922