UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052056 |
|---|---|
| Receipt number | R000059414 |
| Scientific Title | A Study of "Family Doctor Function" Needs and Its Medical Impact in Mito City |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/08/30 15:27:57 |
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Basic information
Public title
A Study of "Family Doctor Function" Needs and Its Medical Impact in Mito City
Acronym
A Study of "Family Doctor Function" Needs and Its Medical Impact in Mito City
Scientific Title
A Study of "Family Doctor Function" Needs and Its Medical Impact in Mito City
Scientific Title:Acronym
A Study of "Family Doctor Function" Needs and Its Medical Impact in Mito City
Region
| Japan |
Condition
Condition
Targeting all disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, with the cooperation of Mito City, we will randomly sample local residents to investigate the needs of Mito residents in terms of their expectations of their family doctor, and to determine what kind of family doctor functions have the desired impact on residents' disease prevention behaviors and health-related outcomes.
Basic objectives2
Others
Basic objectives -Others
In this study, with the cooperation of Mito City, we will randomly sample local residents to investigate the needs of Mito residents in terms of their expectations of their family doctor, and to determine what kind of family doctor functions have the desired impact on residents' disease prevention behaviors and health-related outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
associations with familiar family doctor functions and needs, self-health management behaviors, and health-related outcomes
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mito City residents aged 65 or older in FY2023 who are not certified as requiring long-term care
Key exclusion criteria
not applicable
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Maeno |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3101
maenote@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takami |
| Middle name | |
| Last name | Maeno |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3101
Homepage URL
takami-m@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Mito City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3101
takami-m@md.tsukuba.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
| 2023 | Year | 09 | Month | 01 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects: Mito City residents aged 65 or older in FY2023 who are not certified as requiring long-term care and determined by random sampling of 3,000 persons based on the Basic Resident Ledger.
Primary endpoints: associations with familiar family physician functions and needs, self-health management behaviors, and health-related outcomes
Data Analysis:
1.Self-administered questionnaire survey data
Survey method: A self-administered questionnaire on life, health, financial situation, and attitudes toward family doctors will be sent by mail. Informed consent for participation in the study will be obtained in writing on the survey form, and subjects whose consent has been obtained will be analyzed.
2.Receipt data
Of the data provided to the University of Tsukuba based on the agreement concluded between Mito City and the University of Tsukuba, those data for which the consent of the research participant has been obtained will be used secondarily in this study.
The data used for the analysis include medical and dental receipts (National Health Insurance and Late-Stage Senior Citizen's Health Care System), health checkup data, and nursing care receipts from April 2017 to March 2023 in Mito City. These data will be used for analysis as health-related outcomes, such as the use of medical and nursing care services and the understanding of diseases using disease names, medical practices, and drugs administered.
Throughout the survey, the analysis will be conducted anonymously and the researcher will not identify specific individuals.
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059414
