UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030149 |
|---|---|
| Receipt number | 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 15:11:39 |
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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
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
tanioka.tetsuya@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034367
