UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047226 |
|---|---|
| Receipt number | R000053860 |
| Scientific Title | Construction and inflection of a Nursing Practice Model to Help Persons with Schizophrenia Achieve Work-life Harmony |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2025/03/20 09:09:21 |
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Basic information
Public title
Construction and inflection of a Nursing Practice Model to Help Persons with Schizophrenia Achieve Work-life Harmony
Acronym
Construction and inflection of a Nursing Practice Model to Help Persons with Schizophrenia Achieve Work-life Harmony
Scientific Title
Construction and inflection of a Nursing Practice Model to Help Persons with Schizophrenia Achieve Work-life Harmony
Scientific Title:Acronym
Construction and inflection of a Nursing Practice Model to Help Persons with Schizophrenia Achieve Work-life Harmony
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Working support
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
interview
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
| Behavior,custom |
Interventions/Control_1
interview
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person with schizophrenia
The person who wants to begin to work from now on
The person who worries about continuation working
The person who wants to get the secret to continuation working
Key exclusion criteria
When a psychiatrist, a nurse judge study entry to be difficult
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | sanae |
| Middle name | |
| Last name | nakatogawa |
Organization
kitasato University
Division name
School of Nursing
Zip code
252-0329
Address
2-1-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
0427789281
sanae@nrs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | sanae |
| Middle name | |
| Last name | nakatogawa |
Organization
Kitasato University
Division name
School of Nursing
Zip code
252-0329
Address
2-1-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
TEL
0427789281
Homepage URL
sanae@nrs.kitasato-u.ac.jp
Sponsor or person
Institute
Japan Society for the Promotion of Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Nursing
Address
2-1-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa
Tel
0427788714
ttsukada@kitasato-u.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
| 2022 | Year | 03 | Month | 18 | 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
6
Results
Nursing intervention was conducted with six research subjects. Interviews were conducted 10 to 17 times, once every 1 to 4 weeks.
One person attempted a job interview. One person tried for a job interview, and two people started contacting companies. One person continued the challenge from irregular employment to regular employment. One person made a major change in his/her living environment for his/her professional life. One person who faced the current situation.
Results date posted
| 2023 | Year | 02 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Research activities were restricted due to the effects of COVID19. The nursing interviews (scheduled to be conducted 7 to 10 times in total) for each participant in the study were conducted once a month, which made it difficult to complete the study within the data collection period of the research protocol. An application for change was submitted to the Research Ethics Review Committee and approval was obtained.
The data collection period was extended to April 30, 2023.
Date of the first journal publication of results
Baseline Characteristics
Persons with schizophrenia who have received an explanation of their diagnosis and are aware of it.
The participants were those who were using day care services at psychiatric hospitals and employment support facilities, and who were seeking welfare employment or general employment, and who wanted to start working in the future. Regarding their work experience, some had never worked before and some had repeatedly lost their jobs.
They were in their 30's to 40's. They were anxious about continuous employment and wanted to know the secrets of continuous employment.
Participant flow
The intervention period will be 4 to 5 months. The researcher will create a worksheet by the first month
of the intervention, promote self-understanding based on the worksheet, and then, using the worksheet, review the worksheet (pursuing issues and secrets) and make additional statements with the research subjects for approximately 3 to 4 months afterward. In addition, the researcher prepares a resume and other documents necessary for employment together with the research subjects, and discusses issues for employment together with them. The intervention will be conducted for up to 5 months, depending on the implementation status of the research subjects.
Currently, all subjects have completed the final interview, and member checking was completed on April 22, 2023.
Adverse events
Outcome measures
Facts that provide the basis for judgment of the nursing intervention implemented (mainly the contents that lead to the evaluation of the nursing practice model)
(a) Words and actions related to the implementation of the worksheet on the construction of the secret of how to live in harmony with the subject's work and life.
(b) Changes in consciousness related to the harmonization between work and life, and facts that serve as background for the subject's words and actions
(c) Information on attributes such as age, age of onset, history of hospitalization, family structure, living together, employment experience, and understanding of the patient and family members about the disease and treatment.
Actual nursing interventions and changes in patients in response to those interventions (mainly those that lead to refinement of the nursing practice model)
(a) Details of the nursing intervention by the nurse (researcher)
(b) Reactions and changes of the subject to the nursing intervention
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2026 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053860
