UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a method of Caring in Nursing for the Elderly in Cooperation with a Caring Nurse Robot
Title of the study (Brief title)	Development of a method of Nursing with a Caring Nurse Robot
Region	Japan

Condition
Condition	Mild dementia
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tetsuya Tanioka
Organization	Tokushima University
Division name	Department of Nursing Outcome Management,Institute of Biomedical Sciences
Address	18-15 Kuramoto-cho 3 Tokushima, 770-8509, Japan
TEL	088-633-9021
Email	tanioka.tetsuya@tokushima-u.ac.jp

Public contact
Name of contact person	Tetsuya Tanioka
Organization	Tokushima University
Division name	Department of Nursing Outcome Management,Institute of Biomedical Sciences
Address	18-15 Kuramoto-cho 3 Tokushima, 770-8509, Japan
TEL	088-633-9021
Homepage URL
Email	tanioka.tetsuya@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research (FY2017)<KAKENHI>
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	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)

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 28 Day
Last modified on	2017 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034367