UMIN-CTR Clinical Trial

Public title

Development of a method of Caring in Nursing for the Elderly in Cooperation with a Caring Nurse Robot

Acronym

Development of a method of Nursing with a Caring Nurse Robot

Scientific Title

Development of a method of Caring in Nursing for the Elderly in Cooperation with a Caring Nurse Robot

Scientific Title:Acronym

Development of a method of Nursing with a Caring Nurse Robot

Region

Japan

Condition

Mild dementia

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study consider how to practice nursing as a caring for dementia patients based on the Transactive Relationship Theory of Nursing (TRETON) which developed by Dr. Tanioka, a research director who presented a new relationship between Caring Nurse Robot (CNR) and patients, healthcare providers (nurses, care workers, etc.), and older adults with dementia. This clarifies necessary nursing functions in the transactive relations. Also, clarify the nursing methodology (effects, ethical issues, improvement points, etc.) as a caring in nursing by TRETON when practical use of CNR.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

(1) Sensory evaluation
Evaluate the mood, impression, satisfaction when talking with CNR which improved Pepper.
(2) Verification test
Evaluate the autonomic nervous activity (HF, LF / HF), sleep efficiency, sleeping time, acceleration, activity amount obtained from Actigraph, range of joint motion of upper and lower limbs, isometric muscle strength.

Key secondary outcomes

(1) Sensory evaluation
Analysis of evaluation items by free description

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

1) Natural language dialogue (NLD) program is created in which older adults with dementia can feel enjoy and uplifting. Also, considering ethical issues related to clinical use of caring nurse robot (Sensory evaluation 1).
2) Clarify the function of nursing as caring by TRETON which necessary for CNR. Also prepare a varification test and pre-test of created NLD program (Sensory evaluation 2, Verification test 1,2).
3) CNR with improved Pepper (RP - CNR) is used in the clinical setting. This stage will continue to consider ethical issues. Then, we modify the program based on the verification test (Sensory evaluation 3, Verification test 3). We clarify the necessary nursing functions for healthy elderly people and elderly people with dementia from the database for the RP - CNR obtained in the second and third stages. Also develop an interface for sharing information among the RP-CNR, nurses and other healthcare providers.
4) The RP-CNR will be improved for clinical use and put to practical use.

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

20

years-old

<=

Age-upper limit

95

years-old

>

Gender

Male and Female

Key inclusion criteria

Person who can conduct interpersonal conversation

1. Sensory evaluation 1
(1)120 healthy people who participated in the summer festival at Mifune Hospital
(2) Age ranges 20 - 95
2. Sensory evaluation 2
(1) Healthcare providers working at Mifune Hospital, Fukujyu-sou (120 people)
(2) Age ranges 20 - 65
(3) Those who can measure their blood pressure by themselves and show them to CNR who has improved Pepper
3. Sensory evaluation 3
(1) 120 people including inpatients at Miho Hospital's dementia treatment hospital, residents of Fukujyu-sou, day service users, etc.
(2) Age ranges 65 - 95
(3) Those who can measure blood pressure by hand through an automatic sphygmomanometer and show it to CNR with improved Pepper
4. Verification test 1, 2, 3
1) 90 elderly men and women who have moved to Fukujyu-sou and are undergoing diagnosis of dementia satisfying the following conditions (30 people, 3 times)
(1) Degree of dementia revised Hasegawa formula simple intelligence evaluation scale (HDS - R) 5 - 15 points
(2) Those who can simultaneously measure Actigraph and heart rate variability
(3) Age ranges 70 - 95
2) Healthy adult male and female 90 people (30 people, 3 times) satisfying the following conditions
(1) Nonsmokers who can refrain from alcohol intake during the research cooperation period, and medical workers
(2) People without heart disease
(3) Those who can simultaneously measure Actigraph and heart rate variability
(4) Age ranges 20 - 65
3) 90 healthy elderly men and women with the following conditions (30 people, 3 times)
(1) Those who are non-smokers and who can refrain from alcohol intake during the research cooperation period
(2) People without heart disease
(3) Those who can simultaneously measure Actigraph and heart rate variability
(4) Age ranges 65 - 95

Key exclusion criteria

1. Sensory evaluation 1, 2
Nothing special
2. Sensory evaluation 3
Those who are severely demented and have a lack of conversation and judgment

3. Verification test 1, 2, 3
(1) Those with heart disease are excluded from the subject because they affect the analysis of balance of autonomic nervous activity. However, person with hypertension can include in the subject.
(2) Those who are likely to cause skin symptoms (itching, redness, etc.) on electrode seals and Actigraph for measuring heart rate variability are excluded.
(3) Those taking sleep inducing agents or anxiolytic agents. However, those who are judged by the physician which medicine do not to affect the intervention of this survey can include.

Target sample size

630

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuya Tanioka

Organization

Tokushima University

Division name

Department of Nursing Outcome Management,Institute of Biomedical Sciences

Zip code

Address

18-15 Kuramoto-cho 3 Tokushima, 770-8509, Japan

TEL

088-633-9021

Email

tanioka.tetsuya@tokushima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Tanioka

Organization

Tokushima University

Division name

Department of Nursing Outcome Management,Institute of Biomedical Sciences

Zip code

Address

18-15 Kuramoto-cho 3 Tokushima, 770-8509, Japan

TEL

088-633-9021

Homepage URL

Email

tanioka.tetsuya@tokushima-u.ac.jp

Institute

Tokushima University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research (FY2017)<KAKENHI>

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三船病院（香川県）、介護老人保健施設福寿荘（香川県）/ Mifune Hospital(Kagawa), Fukujusou(Kagawa)

Date of disclosure of the study information

2017

Year

12

Month

15

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

Preinitiation

Date of protocol fixation

2018

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2018

Year

01

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

28

Day

Last modified on

2017

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034367