UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051082 |
|---|---|
| Receipt number | R000058254 |
| Scientific Title | Effects of Nurses to Continuously Practice by a Nursing Practice Model for Glycerin Enema and Digital Extraction of Feces for Elderly People who Require At-home Nursing Care |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/05/17 12:44:02 |
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Basic information
Public title
Effects of Nurses to Continuously Practice by a Nursing Practice Model for Glycerin Enema and Digital Extraction of Feces for Elderly People who Require At-home Nursing Care
Acronym
Effects of Nurses to Continuously Practice by a Nursing Practice Model for Defecationing Support at Home
Scientific Title
Effects of Nurses to Continuously Practice by a Nursing Practice Model for Glycerin Enema and Digital Extraction of Feces for Elderly People who Require At-home Nursing Care
Scientific Title:Acronym
Effects of Nurses to Continuously Practice for Defecationing Support by a Nursing Practice Model for Elderly People who Require At-home Nursing Care
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of Nurses to Continuously Practice by a Nursing Practice Model for Glycerin Enema and Digital Extraction of Feces for Elderly People who Require At-home Nursing Care
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bowel movements
Key secondary outcomes
Number of home-visit nursing care visits
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Continuously Practice for Defecationing Support by a Nursing Practice Model
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
Patients with care level 3 or higher
Patients who cannot defecate on their own
Key exclusion criteria
Patients with no specific disease
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Kurita |
Organization
University of Human Environments
Division name
Graduate of Nursing
Zip code
474-0035
Address
3-220, Ebatas-cho, Obu-city, Aichi, Japan
TEL
0562-43-0701
a-kurita@uhe.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Kurita |
Organization
University of Human Environments
Division name
Graduate of Nursing
Zip code
474-0035
Address
3-220, Ebatas-cho, Obu-city, Aichi, Japan
TEL
0562-43-0701
Homepage URL
a-kurita@uhe.ac.jp
Sponsor or person
Institute
University of Human Environments
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Human Environments Human Environments Ethics Committee
Address
3-220, Ebatas-cho, Obu-city, Aichi, Japan
Tel
0562-43-0701
a-kurita@uhe.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 | 05 | Month | 19 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2025 | 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 | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
