UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025411 |
|---|---|
| Receipt number | R000028930 |
| Scientific Title | The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2020/12/20 11:50:23 |
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Basic information
Public title
The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Acronym
The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Scientific Title
The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Scientific Title:Acronym
The effect of referral form on hypertension treatment rate in Japanese hypertensive employees: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether giving a referral form at the annual health checkup improve proportion of patients with hypertension treatment among Japanese hypertensive workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Outpatient visit for hypertension after 6 months evaluated by the health insurance claim data.
Key secondary outcomes
Blood pressure, frequency of outpatient visit, change of antihypertensive agents after 2 years and additional exploratory analysis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Recommendation for the treatment of hypertension at the time of the annual health checkup using both the referral form to general practitioners and a leaflet for hypertension control.
Interventions/Control_2
Recommendation for the treatment of hypertension using a leaflet for hypertension control.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Having Grade I hypertension in 2016
2) Having Grade II hypertension in 2017
3) Untreated in 2017
4) Consent to participate in the study
Key exclusion criteria
1) Pregnant in 2016 or 2017
2) Having antihypertension agents in 2017
3) SBP >=190 or DBP >= 120 in 2017
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Miyamatsu |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL
077-548-2437
shiazusa@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Azusa |
| Middle name | |
| Last name | Shima |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL
077-548-2437
Homepage URL
shiazusa@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Clinical Nursing, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee.
Address
Setatsukinowacho, Otsu, Shiga 520-2192
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
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
| 2017 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028930
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41440-020-00559-0
Number of participants that the trial has enrolled
287
Results
Early promotion using a referral letter during health checkups significantly increased the number of clinic visits within 6 months completed by participants with untreated hypertension.
Results date posted
| 2020 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 14 | Day |
Baseline Characteristics
Japanese employees with hypertension (mean age 50.3 years, 55% women)
Participant flow
Eligible participants: 330
Consented participants: 287
Followed and analyzes participants: 273
Adverse events
No adverse effect reported
Outcome measures
The completion of a clinic visit within 6 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028930
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 20190409__Protocol_高血圧紹介状cRCT_5版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/14 | CRF.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 研究症例データ.docx |
