UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052503 |
|---|---|
| Receipt number | R000055174 |
| Scientific Title | Evaluation of the efficacy of resilience support provided by home nurses to schizophrenia living in the community |
| Date of disclosure of the study information | 2023/10/15 |
| Last modified on | 2023/10/15 18:55:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the efficacy of resilience support provided by home nurses to schizophrenia living in the community
Acronym
Evaluation of the efficacy of resilience support provided by home nurses to schizophrenia living in the community
Scientific Title
Evaluation of the efficacy of resilience support provided by home nurses to schizophrenia living in the community
Scientific Title:Acronym
Evaluation of the efficacy of resilience support provided by home nurses to schizophrenia living in the community
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy of resilience support provided by home nurses to people with schizophrenia and living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resilience 2 and 3 months after the start of support
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the intervention group, resilience support will be provided to each participant for at least 15 minutes once a week for a total of 8 weeks. Data collection for the intervention group will be conducted at three time points: before the intervention, 2 months after the start of the intervention, and 3 months after the start of the intervention.
Interventions/Control_2
The control group will receive only the care provided by regular home-visit nursing. Data collection will occur at a similar time to the intervention group.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People with schizophrenia living in the community
Those who use home-visit nursing at least once a week
Those who use day care more than once a week
Those who can communicate verbally in Japanese and answer self-administered survey forms.
Key exclusion criteria
Persons with cerebrovascular disease or dementia
Persons with severe intellectual disability
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsubu |
| Middle name | |
| Last name | Matsuda |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3534
mmatsuda@omu.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Ohira |
Organization
Gifu University
Division name
School of Medicine Nursing Course
Zip code
501-1193
Address
1-1 Yanagido, Gifu City 501-1193, JAPAN
TEL
058-293-3238
Homepage URL
ohira.sachiko.w4@f.gifu-u.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Osaka Metropolitan University Graduate School of Nursing
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
Tel
06-6645-3534
mmatsuda@omu.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 | 10 | Month | 15 | 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
44
Results
As a result of providing resilience support for 8 weeks by visiting nurses to people with schizophrenia living in the community, GAF, fear of discontinuing medication (a subscale of MPS), DAI-10, total score of SECL, and subscales of The intervention group showed significant improvement in certain aspects of social life and interpersonal relationships.
Results date posted
| 2023 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences between the intervention and control groups in terms of age, gender, marital status, cohabitation, years of home nursing use, number of visits, number of hospitalizations, and use of social resources other than day care. However, significant differences were found for time per visit and GAF scores before the intervention.
Participant flow
Cooperation was obtained from two facilities in the intervention group and three facilities in the control group. In the intervention group, 23 people started the study and 21 people completed it. On the other hand, in the control group, 21 people started the survey and 16 people completed it. The reasons for dropping out of the intervention group were 1 patient due to deterioration of medical condition and 1 patient moving, and the reasons for dropping out of the control group were 3 patients due to worsening of medical condition and 2 patients not responding to the survey. Those who completed the survey in both groups with missing values were excluded from the analysis, leaving 17 participants in the intervention group and 15 in the control group.
Adverse events
None
Outcome measures
1.MPS:Medication Perception Scale
2.DAI-10:Drug attitude inventory-10 Questionnaire
3.SWBS:Subjective Well-Being Scale.
4.SECL:Self-Efficacy for Community Life Scale
5.GAF:Global Assessment of Functioning
6.Sense of place scale for people with mental illness
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 10 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
