UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031831
Receipt number R000036353
Scientific Title The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Date of disclosure of the study information 2018/04/01
Last modified on 2022/04/01 20:33:25

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Basic information

Public title

The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.

Acronym

The effects of intervention using case conferences on staff well-being in long-term care hospitals.

Scientific Title

The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.

Scientific Title:Acronym

The effects of intervention using case conferences on staff well-being in long-term care hospitals.

Region

Japan


Condition

Condition

Mental health

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To conduct the intervention using case conferences and evaluate its effects on the mental health among nurses and care workers working in long-term care hospitals.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Burnout will be measured by the 17- item Japanese Burnout scale. Work engagement will be measured by the Japanese short version of the Utrecht work engagement scale.

We will conduct self-administered, anonymous questionnaire surveys four times: before the intervention (Baseline: Time 0), 3 months after the intervention (Time 1), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).

Key secondary outcomes

The perception of support from nursing managers and colleagues, care quality in their ward and job demands.Furthermore, physical restraint, urinary tract infection, incidence of pressure ulcer, number of patients who fell down and so on.

In addition to questionnaire surveys, We will conduct chart review: before the intervention (Baseline: Time 0), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

This intervention will consist of monthly,60-minute sessions, for a total of 6 months.

Course A
Receive intervention using case conferences first(Intervention group).

Interventions/Control_2

Course B
Receive intervention in the later phase (Control 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

Nurses and care workers working in the long-term care hospitals.

Key exclusion criteria

Nurses and care workers who decline in the participation of this study.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Noriko
Middle name
Last name Yamamoto-Mitani

Organization

The University of Tokyo
Graduate School of Medicine
School of Health Sciences and Nursing

Division name

Department of Gerontological Home-Care & Long-term Care Nursing

Zip code

113-0033

Address

7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan

TEL

03-5841-3508

Email

noriko-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yumiko
Middle name
Last name Saito

Organization

The University of Tokyo Graduate School of Medicine School of Health Sciences and Nursing

Division name

Department of Gerontological Home-Care & Long-term Care Nursing

Zip code

113-0033

Address

7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan

TEL

03-5841-3508

Homepage URL


Email

syumiko-tky@umin.ac.jp


Sponsor or person

Institute

Department of Gerontological Home-Care & Long-term Care Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Nippon Life Insurance Foundation and
the Univers Foundation.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2018 Year 04 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


Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

From April 2018 to March 2019, we conducted an intervention using case conferences for nurses and care workers in nine long-term care hospitals (five intervention groups and four control groups). After the implementation of the intervention, we conducted questionnaires and medical record surveys to verify the effectiveness of the intervention. We completely collected data through questionnaires and medical record surveys without any problems, and the data is currently being analyzed.

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

Not applicable

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 02 Month 09 Day

Date of IRB

2017 Year 09 Month 04 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2022 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 21 Day

Last modified on

2022 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name