UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030149
Receipt No. R000034367
Scientific Title Development of a method of Caring in Nursing for the Elderly in Cooperation with a Caring Nurse Robot
Date of disclosure of the study information 2017/12/15
Last modified on 2017/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.