UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054482 |
|---|---|
| Receipt number | R000062229 |
| Scientific Title | The evaluation study on multilingual telemonitoring-based telenursing |
| Date of disclosure of the study information | 2024/05/24 |
| Last modified on | 2024/05/24 20:59:43 |
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Basic information
Public title
The evaluation study on multilingual telemonitoring-based telenursing
Acronym
The evaluation study on multilingual telemonitoring-based telenursing
Scientific Title
The evaluation study on multilingual telemonitoring-based telenursing
Scientific Title:Acronym
A study on multilingual telenursing
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD),Type 2 Diabetes, Amyotrophic Lateral Sclerosis (ALS), Lung Cancer, Kidney Failure on Peritoneal Dialysis
Classification by specialty
| Pneumology | Endocrinology and Metabolism | Nephrology |
| Neurology | Chest surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the outcomes of providing home-monitoring-based telenursing for adults and older adults residing in Japan, who are native speakers of English, Chinese, or Japanese, and who suffer from Chronic Obstructive Pulmonary Disease (COPD), Type 2 Diabetes (T2DM), Amyotrophic Lateral Sclerosis (ALS), Lung Cancer, or Kidney Failure on Peritoneal Dialysis. The outcomes will be assessed through: (1) the stability of daily monitoring values and the occurrence of threshold events, (2) satisfaction levels (VAS-10), (3) quality of life [quantitative data], and (4) thoughts and textual features related to telenursing and self-care [qualitative data]. By converging these two types of data, the study aims to meta-infer the cultural influences on the process by which foreign residents and Japanese integrate telenursing into their daily lives, and to evaluate the utilization of multilingual telenursing.
Basic objectives2
Others
Basic objectives -Others
To meta-infer the cultural influences on the process by which foreign residents and Japanese integrate telenursing into their daily lives.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The stability of daily monitoring values and the occurrence of threshold events.
Key secondary outcomes
Satisfaction with telenursing, quality of life, attitudes toward telenursing and self-care, cultural characteristics affecting acceptance of telenursing, self-efficacy, sense of security, depression, changes in medication prescriptions, and medical expenses.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Home-monitoring-based telenursing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals who regularly visit outpatient clinics and receive continuous medical care.
2)Individuals who have undergone surgical treatment and continue to visit the same medical institution after discharge.
3)Individuals for whom the consent of their attending physician for participation in this study is obtained.
4)Individuals who can secure a location in their home to install a set of tablet devices and measuring equipment.
5)Individuals who are able to respond to and transmit answers to self-measurements such as blood pressure and oxygen saturation, as well as questionnaire items from tablet devices, and who have no impairment in cognitive or limb function, or have alternative means.
6)Individuals who can continue to use existing services such as long-term care insurance and social systems during the research collaboration period, regardless of whether they are using them or not.
7)Individuals aged 20 years or older.
8)Individuals residing in Japan and receiving outpatient care, whose native language is Japanese, English, or Chinese.
9)Individuals for whom written consent for participation in this study can be obtained directly from themselves.
Key exclusion criteria
1)Individuals receiving treatment during acute exacerbations.
2)Individuals with cognitive impairment, severe depression, reduced limb function, or other issues making it difficult to use telenursing equipment.
3)Individuals in the terminal stage of illness.
4)Other individuals deemed unsuitable by the principal investigator (co-researcher).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1, Akashi-chou, Chuo-ku, Tokyo
TEL
0355502283
kamei@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1 Akashi-chou, Chuo-ku, Tokyo
TEL
0355502283
Homepage URL
kamei@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of St. Luke's International University
Address
10-1 Akashi-chou, Chuo-ku, Tokyo
Tel
0335436391
kamei@slcn.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 24 | 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
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062229
