UMIN-CTR Clinical Trial

Public title

Identifying the profiles of patients and families provided by home-visit nursing services using medical records: A retrospective cohort study

Acronym

Identifying the profiles of patients and families provided by home-visit nursing services using medical records: A retrospective cohort study

Scientific Title

Identifying the profiles of patients and families provided by home-visit nursing services using medical records: A retrospective cohort study

Scientific Title:Acronym

Identifying the profiles of patients and families provided by home-visit nursing services using medical records: A retrospective cohort study

Region

Japan

Condition

Patients and their families receiving home health care services from home-visit nursing agencies

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To identify the following characteristics of the patients and their families who receive home health care services from home-visit nursing agencies using medical records.
1) Medical characteristics at the time of starting to use the home nursing station (ex. age, gender, disease,and use of medical device)
2) Symptoms or conditions, knowledge, behaviors, situations, and care plans of patients and/or their families assessed in home health care services.
3) Utilization of the services one year after receiving the home-visit nursing agencies

Basic objectives2

Others

Basic objectives -Others

To identify the resources invested by home-visit nursing agencies, including duration of the use of home-visit nursing care, frequency of the visits, use during the night and early morning, and the number of medical staff.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Medical characteristics at the time of starting to use the home nursing station (ex. age, gender, disease,and use of medical device)

Key secondary outcomes

- Symptoms or conditions, knowledge, behaviors, situations, and care plans of patients and/or their families assessed in home health care services.
- Utilization of the services one year after receiving the home-visit nursing agencies
- The resources invested by home-visit nursing agencies, including duration of the use of home-visit nursing care, frequency of the visits, use during the night and early morning, and the number of medical staff

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Users who received home health care services from WyL Inc. from 1 January 2017 to 31 December 2022 and who meet all of the following criteria:
1) Those who received the services from the Edogawa or Urawa Office of home-visit nursing agencies in WyL Inc.
2) Those who received the first visit of home care nursing between 1 January 2017 and 31 December 2021.
3) Those whose medical records were registered in the electrical medical record system

Key exclusion criteria

People who have refused to allow their data to be used for this study.

Target sample size

500

Name of lead principal investigator

1st name	Ai
Middle name
Last name	Tomotaki

Organization

Tokai University

Division name

Faculty of Nursing, School of Medicine

Zip code

259 -1193

Address

143 Shimokasuya, Isehara-shi, Kanagawa, Japan

TEL

0463-93-1121

Email

atomotaki-tky@umin.ac.jp

Name of contact person

1st name	Ai
Middle name
Last name	Tomotaki

Organization

Tokai University

Division name

Faculty of Nursing, School of Medicine

Zip code

259 - 1193

Address

143 Shimokasuya, Isehara-shi, Kanagawa, Japan

TEL

0463-93-1121

Homepage URL

Email

hcdc.info@umin.ac.jp

Institute

Tokai University

Institute

Department

Personal name

Organization

Seseragi Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

WyL Inc.
WyL Group,Inc.
International University of Health and Welfare
Shizuoka Graduate University of Public Health
Tokyo Medical and Dental University
Tokyo University

Name of secondary funder(s)

Organization

Institutional Review Board for Clinical Research,Tokai University

Address

Shimokasuya 143, Isehara-shi, Kanagawa, Japan

Tel

0463-93-1121

Email

tokai-rec@tsc.u-tokai.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

WyL株式会社

Date of disclosure of the study information

2023

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

04

Month

14

Day

Date of IRB

2023

Year

04

Month

26

Day

Anticipated trial start date

2023

Year

04

Month

26

Day

Last follow-up date

2023

Year

04

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Study design: Retrospective cohort study
2. Statistical methods
1) Characteristics at the start of the user's use.
- Mean, standard deviation, and percentile values are calculated for continuous data variables.Frequencies and percentiles are calculated for categorical data variables.
- The three domains of the Omaha system (Problem, intervention, and outcome) with a five-point Likert scale will be addressed for both continuous and categorical data, taking into account the distribution of data.
- These data are calculated by some subgroups including age groups(- 6years, 7-18 years, 19-49 years, 50-64 years, 65-74 years, and 75 years-).

2) Administrative data of the home-visit nursing agencies
- The following variables are tabulated: the number and percentage of staff members including nurses, physiotherapists, occupational therapists,and speech therapis, and their age.
- The number of users per office and date of opening the office are described.

3) One-year outcome after using the home nursing station One-year usage from the date of first use
- The number of days until the end of use is calculated using a histogram and the quartiles.

4) Utilization of the home-visit care services for one year
- The histogram and quartiles of days after starting of use of the home-visit care services are described.
- The Kaplan-Meier curves of utilization status including the end due to hospitalisation/admission, cure, and death) are displayed with some subgroups.

Registered date

2023

Year

07

Month

08

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058247