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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020479
Receipt No. 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

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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
Email 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
Email ns150011@tmd.ac.jp

Sponsor
Institute Department of System Management in Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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