UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051829
Receipt number R000058579
Scientific Title A study on the effects of a case study-based delirium and dementia care education program for nurses in acute care hospitals
Date of disclosure of the study information 2023/08/04
Last modified on 2024/04/18 10:44:11

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Basic information

Public title

A study on the effects of a case study-based delirium and dementia care education program for nurses in acute care hospitals

Acronym

Comparative study before and after delirium and dementia care education program

Scientific Title

A study on the effects of a case study-based delirium and dementia care education program for nurses in acute care hospitals

Scientific Title:Acronym

Comparative study before and after delirium and dementia care education program

Region

Japan


Condition

Condition

Dementia and Delirium

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to implement a case study-based delirium and dementia care education program for nurses in acute care hospitals, and to examine changes in nurses' self-efficacy regarding delirium and dementia care before and after the program. , to clarify the effectiveness of the program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subjects' self-efficacy scores for delirium/dementia care one month before the intervention, immediately after the intervention, and one month after the intervention.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

A study session on delirium and dementia care will be held from November 1st to November 10th, 2023 for those who have given their consent. Then, from November 11, 2023 to February 10, 2024, we will hold two to three 30-minute case review sessions (delirium, dementia care, physical restraints, best practices, etc.) per week. have understood. . , Observe the number and content of the actual implementation. Before the intervention, immediately after the intervention, and one month after the intervention, we will obtain information on self-efficacy regarding delirium/dementia care through questionnaires. Compare the before and after of the acquired data.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Nurses belonging to the research ward of A hospital as of October 2023
2. Those who actually handle patients
2. Subjects who were able to obtain informed consent for this research

Key exclusion criteria

1. Those who do not actually deal with patients
2. Nurses belonging to wards such as obstetrics and gynecology wards and pediatrics wards that are thought to have few elderly patients

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Mizue
Middle name
Last name Suzuki

Organization

Hamamatsu University School of Medicine

Division name

Department of Nursing, School of Medicine,Clinical nursing course.

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture.

TEL

0534352111

Email

m-suzuki@hama-med.ac.jp


Public contact

Name of contact person

1st name Hisanobu
Middle name
Last name Moriyama

Organization

Hamamatsu University School of Medicine

Division name

Department of Nursing, Graduate School of Medicine.

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture.

TEL

0534352111

Homepage URL


Email

M21016@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

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

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture.

Tel

0534352111

Email

rinri@hama-med.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

中東遠総合医療センター(静岡県)


Other administrative information

Date of disclosure of the study information

2023 Year 08 Month 04 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

Suspended

Date of protocol fixation

2023 Year 04 Month 14 Day

Date of IRB

2023 Year 06 Month 06 Day

Anticipated trial start date

2023 Year 07 Month 01 Day

Last follow-up date

2023 Year 12 Month 10 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 08 Month 04 Day

Last modified on

2024 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name