UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049026 |
|---|---|
| Receipt number | R000055858 |
| Scientific Title | Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses: A wait listed randomized control trials |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2024/03/30 09:29:20 |
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Basic information
Public title
Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses: A wait listed randomized control trials
Acronym
Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses: A wait listed randomized control trials
Scientific Title
Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses: A wait listed randomized control trials
Scientific Title:Acronym
Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses: A wait listed randomized control trials
Region
| Japan |
Condition
Condition
Nurse
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of an educational program about primary palliative care for heart failure among registered nurses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PCPS(Palliative Care Self-Reported Practices Scale)heart failure version
Comparison of mean values in the intervention group and the waiting group at 6 month after the education program
Key secondary outcomes
1,PCDS(Palliative Care Difficulties Scale)heart failure version
2,Percentage of correct answers on knowledge tests about palliative care for heart failure
Comparison of mean values in the intervention group and the waiting group at 6 month after the education program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participation in "Heart Failure Palliative Care Education Program for Nurses"
Interventions/Control_2
waiting 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinical Ladder Level II (Practice Nursing Independently Based on Standard Nursing Care Plan) shown by the Japanese Nursing Association
Key exclusion criteria
Nurses who are not directly involved in heart failure patients
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Tokyo Women's Medical University
Division name
Department of Nursing
Zip code
162-8666
Address
8-1 Kawadachou, shinjyuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8112
wakabayashi.rumi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Rumi |
| Middle name | |
| Last name | Wakabayashi |
Organization
Tokyo Women's Medical University
Division name
Department of Nursing
Zip code
162-8666
Address
8-1 Kawadachou, shinjyuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8112
Homepage URL
wakabayashi.rumi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokyo Women's Medical University
Address
8-1 Kawadacho Shinjuku Tokyo
Tel
03-3353-8112
rinri.bm@twmu.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 | 10 | Month | 01 | 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
157
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055858
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
