UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054298 |
|---|---|
| Receipt number | R000062016 |
| Scientific Title | The efficacy of Staff Education for Health Care Professionals Involved in the Care of Patients with Parkinson's Disease - An Educational Program for Staff at a Newly Opened Facility |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2025/01/10 12:02:00 |
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Basic information
Public title
The efficacy of Staff Education for Health Care Professionals Involved in the Care of Patients with Parkinson's Disease - An Educational Program for Staff at a Newly Opened Facility
Acronym
The efficacy of Staff Education for Health Professionals Involved in the Care of Patients with Parkinson's Disease
Scientific Title
The efficacy of Staff Education for Health Care Professionals Involved in the Care of Patients with Parkinson's Disease - An Educational Program for Staff at a Newly Opened Facility
Scientific Title:Acronym
The efficacy of Staff Education for Health Professionals Involved in the Care of Patients with Parkinson's Disease
Region
| Japan |
Condition
Condition
Healthy adults (Medical Professionals)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the educational efficacy of a one-month educational program (opening training) for medical professionals who will be part of a newly opened PD House, a residential care home specializing in Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-assessment of knowledge and confidence in caring for PD patients
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Opening training classified by the following items will be conducted over a period of one month
Orientation, hospitality training, philosophy training, lectures on basic knowledge of Parkinson's disease, training on equipment installed in the facility, etc. (1 week)
Training by job category (nursing, care, rehabilitation) (1 week)
Preparation for opening a new facility, role-playing on the assumption of Parkinson's disease patients moving in, etc. (2 weeks)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who are 18 years of age or older at the time of obtaining consent.
2. Medical professionals (nurses, caregivers, rehabilitation workers) affiliated with the newly opened facility.
3. Persons who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1. Medical professionals who have worked in private nursing homes specializing in Parkinson's disease.
2. Other persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
TEL
072-804-2542
ta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Makio |
| Middle name | |
| Last name | Takahashi |
Organization
Kansai Medical University
Division name
Department of Neurodegenerative Disorders
Zip code
573-1191
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
TEL
072-804-2542
Homepage URL
ta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Sunwells Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1, Hirakata-City, Osaka, 573-1010, JAPAN
Tel
072-804-0101
rinriirb@hirakata.kmu.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
| 2024 | Year | 05 | Month | 08 | 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
117
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062016
