UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020479 |
|---|---|
| Receipt number | R000023658 |
| Scientific Title | Evaluation of an education program for nurses on their knowledge and attitude of end-of -life care towards older adults |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2020/04/12 12:31:17 |
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Basic information
Public title
Evaluation of an education program for nurses on their knowledge and attitude of end-of -life care towards older adults
Acronym
Evaluation of an education program for nurses on end-of -life care towards older adults
Scientific Title
Evaluation of an education program for nurses on their knowledge and attitude of end-of -life care towards older adults
Scientific Title:Acronym
Evaluation of an education program for nurses on end-of -life care towards older adults
Region
| Japan |
Condition
Condition
Nurses who take care of older adults with end of life stage
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.We would like to clarify the effectiveness for nurse's attitude and knowledge of end-of-life care by two days educational program on end- of-life care towards older adults
2.We would like to clarify the effectiveness for nurse's attitude and knowledge of end-of-life care by answering the nurses attitude and knowledge scale on EOL care survey for older adults
3.We would like to clarify the differences of each result to compare of both, the EOL educational program group and the answering scale group effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Nurse's attitude scale on end-of-life care towards older adults(six months later)
Key secondary outcomes
Nurse's knowledge scale on end-of-life care towards older adults(six months later)
Frommelt Attitude Toward Care Of Dying scale - Form B - Japanese short version(six months later)
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
| Other |
Interventions/Control_1
Subjects will attend two days educational program of End-of-life care towards older adults. That educational program is about End-of-Life Nursing Education Consortium-Japan Geriatric (ELNEC-JG) .
Interventions/Control_2
None (Subjects who will not attend the educational program will answer the survey questionnaire on End-of-Life care attitude and knowledge.)
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
1.Educational program group
Nurses who meet criteria below;
1) The nurses who take care of older adults with end of life care setting.
2)The nurses who are interested in ELNEC-JG by seeing the advertisement of ELNEC-JG.
3)The nurses who agreed to participate on this research.
1.Questionnaire group
Nurses who meet criteria below;
1) The nurses who work in facilities which provide end-of life care for older adults frequently such as, hospitals which have a long term care ward and chronic care ward.
2)The nurses who agreed to participate on this research.
Key exclusion criteria
We don't have any exclusion criteria.
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Fukahori |
Organization
Graduate School of Health Care Sciences Tokyo Medical and Dental University
Division name
Department of System Management in Nursing
Zip code
133-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5352
hfukahori.kanr@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | Okumura |
| Last name | Hiroshige |
Organization
Graduate School of Health Care Sciences Tokyo Medical and Dental University
Division name
Department of System Management in Nursing
Zip code
133-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111(7234)
Homepage URL
ns150011@tmd.ac.jp
Sponsor or person
Institute
Department of System Management in Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The research grant on hospice palliative care from the Sasakawa Memorial Health Foundation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science
Grants-in-Aid for Scientific Research
IRB Contact (For public release)
Organization
the Ethics Committee at Tokyo Medical and Dental University
Address
1-5-45 Bunkyo-ku Yushima, Tokyo
Tel
03-3813-6111
syomu1.adm@tmd.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
東京医科歯科大学（東京都）
Tokyo Medical and Dental University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/opn.12309
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/opn.12309
Number of participants that the trial has enrolled
142
Results
The change in mean value of the attitude scale from baseline to 3 months (differences in the groups' attitude scores = 7.33; p = .004) and 6 months (differences in groups' attitude scores = 5.77; p = .044) was greater in the intervention group. Moreover, the mean knowledge scale score change from baseline to 3 months was greater in the intervention group (differences in groups' knowledge scores = 5.74; p < .001). There was no evidence of a change in this score between baseline and 6 months.
Results date posted
| 2020 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 27 | Day |
Baseline Characteristics
Most participants were female Registered Nurses. Mean nursing experience was 17.58 years, and 51.4% worked in a long-term care
hospital or facility.
Participant flow
In the intervention group, the questionnaire was distributed to 164 people, all of whom provided written consent and returned the questionnaire (100% response rate), and took the programme, with 121 responding through 6 months postintervention (73.8% response rate). In the control group, a total of 306 questionnaires were distributed to nine institutions providing EOL care; 174 respondents (56.9% response rate) provided written consent and returned the survey, while 141 respondents (46.1% response rate) responded through 6 months postsurvey. The analysis included 71 subjects with no missing values (43.3% response rate) and 71 controls (23. 2% response rate). The number of dropouts from baseline to analysis was 91 in the intervention group (56.7% dropout rate) and 103 in the
control group (59.2% dropout rate).
Adverse events
Nothing
Outcome measures
The EOL care nursing attitude scale for Japanese geriatric nurses (ELNAS-JG)
The EOL care nursing knowledge scale for Japanese geriatric nurses (ELNKS-JG)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023658
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