UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049787 |
|---|---|
| Receipt number | R000056061 |
| Scientific Title | Prospective Observational Study Implementing and Validating Digital Transformation in Home Medical Care by Linking ePRO and Electronic Medical Records (POSITIVE PRO) |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2023/12/18 09:35:11 |
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Basic information
Public title
Prospective Observational Study on the Implementation of Digital Transformation of Home Medical Care
Acronym
Study on the Implementation of Digital Transformation of Home Medical Care
Scientific Title
Prospective Observational Study Implementing and Validating Digital Transformation in Home Medical Care by Linking ePRO and Electronic Medical Records (POSITIVE PRO)
Scientific Title:Acronym
POSITIVE PRO
Region
| Japan |
Condition
Condition
Patients have been receiving and planning to receive home medical care.
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By linking ePRO data and electronic medical records for home medical care, (1) to prospectively evaluate the impact on subject life prognosis, and (2) to identify the challenges and obstacles when implementing ePRO data linking into electronic medical records in home medical care.
Basic objectives2
Others
Basic objectives -Others
To evaluate the usefulness of implementing ePRO data into home medical care based on 1-year event-free survival proportion (death or hospitalization)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1-year event-free survival proportion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Remote monitoring with ePRO data in home medical care
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Tentative registration]
1. Patients have been receiving and planning to receive home medical care by research institutions at their homes or homes for the elderly .
2. No history of hospitalization for 5 months before the date of informed consent (IC).
3. Written informed consent obtained from the patient/legal representative.
[Registration]
1. No death or hospitalization has been occurred during the tentative registration period.
2. Patients with vital sign alert settings during the 1-month baseline period
Key exclusion criteria
[Tentative registration]
1. Patients who are receiving terminal care due to malignant disease and are not expected to survive for one year at the time of tentative registratoin.
2. Patients and care givers who may not be able to use the ePRO system.
[Registration]
1. Patients and care givers who could not use the ePRO system.
2. Patients determined by the investigators to be ineligible for enrollment for other reasons.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | MUNENORI |
| Middle name | |
| Last name | TAKATA |
Organization
Tohoku University Hospital
Division name
Clinical Research Data Center
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7173
takatam@crietodc.hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | MUNENORI |
| Middle name | |
| Last name | TAKATA |
Organization
Tohoku University Hospital
Division name
Clinical Research Data Center
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7173
Homepage URL
takatam@crietodc.hosp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Clinical Research Data Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Tohoku University Fund (Crowdfunding)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
医療法人財団南葛勤医協 芝診療所（東京都）/Shiba Clinic (Tokyo)
医療法人社団陽和会 武蔵野陽和会病院（東京都）/Musashino Yowakai Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056061
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
