UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049247 |
|---|---|
| Receipt number | R000056089 |
| Scientific Title | Evaluation of self-care program for patients who have physical illness associated wit depressive symptoms and acting out behaviors |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/10/18 14:44:42 |
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Basic information
Public title
Evaluation of self-care program for patients who have physical illness associated wit depressive symptoms and acting out behaviors
Acronym
Evaluation of self-care program for patients who have physical illness associated wit depressive symptoms and acting out behaviors
Scientific Title
Evaluation of self-care program for patients who have physical illness associated wit depressive symptoms and acting out behaviors
Scientific Title:Acronym
Evaluation of self-care program for patients who have physical illness associated wit depressive symptoms and acting out behaviors
Region
| Japan |
Condition
Condition
chronic physical illness
Classification by specialty
| Medicine in general | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate a self-care program called PAS-SCTconducted on patients
who have physical illness associated with moderate depressive symptoms and acting out behaviors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
depression,acting out
Key secondary outcomes
self-care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
self-care program
Interventions/Control_2
nursing care
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic illness
Key exclusion criteria
not terminal stage
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shiori |
| Middle name | |
| Last name | Usami |
Organization
Home-visit nursing station sorahiro
Division name
home-visit
Zip code
861-8001
Address
Kumamoto-city,kita-ku,musashigaoka
TEL
0962748742
hokan@sorahiro.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Usami |
Organization
Home-visit nursing station sorahiro
Division name
Home-visit nursing
Zip code
861-8001
Address
Kumamoto-city,kita-ku,musashigaoka
TEL
0972748742
Homepage URL
hokan@sorahiro.jp
Sponsor or person
Institute
H-me-visit nursing station sorahiro
Institute
Department
Personal name
Funding Source
Organization
Social insuarance union of societies related to nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics commeettee Shitennoji University
Address
1-6-9-B103,MUSASSHIGAOKA,KITA-KU,KUMAMOTOCITY
Tel
0962748742
HOKAN
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 | 03 | Month | 31 | 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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056089
