UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041439 |
|---|---|
| Receipt number | R000047221 |
| Scientific Title | An empirical study for establishment of nursing-collaborated community care system, Asahikawa/Hokkaido model, using telemedicine and IoT devices |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2020/08/17 12:16:38 |
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Basic information
Public title
An empirical study for establishment of nursing-collaborated community care system, Asahikawa/Hokkaido model, using telemedicine and IoT devices
Acronym
An empirical study for establishment of nursing-collaborated community care system, Asahikawa/Hokkaido model, using telemedicine and IoT devices
Scientific Title
An empirical study for establishment of nursing-collaborated community care system, Asahikawa/Hokkaido model, using telemedicine and IoT devices
Scientific Title:Acronym
An empirical study for establishment of nursing-collaborated community care system, Asahikawa/Hokkaido model, using telemedicine and IoT devices
Region
| Japan |
Condition
Condition
Sarcopenia, Dysbasia, Dysphagia, Hypertension, Insomnia, Constipation
Classification by specialty
| Medicine in general | Gastroenterology | Geriatrics |
| Psychiatry | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is crucial to establish global medical/care models which enable elderly people to live healthy and securely under rapidly growing proportion of elderly people in the world. To date, community care system has been developed in Japan, however, the system is optimized for urban area but not rural area. Rural areas have less medical resource than urban areas, it is therefore required to establish care system adjusted to rural area.
The aim of this study is to explore the efficacy of telemedicine system with IoT/ICT technique for elderly adult-adjusted medical service, including rehabilitation and patient compliance instruction, on the various conditions in rural areas without enough medical resources.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Rehabilitation
1) Fall prevention telerehabilitation
The efficacies of the rehabilitation are assessed by Berg Balance Scale (BBS), Timed Up & Go test (TUG test), Hand-held dynamometer (HHD) and Mini-Mental State Examination (MMSE) before and 1, 2 and 3 months after telerehabilitation.
2) Swallowing function evaluation
The efficacies of the rehabilitation are assessed by swallowing sound, tongue pressure, repetitive saliva swallowing test and the number of syllable repetitions of oral diadochokinesis before and 1, 2 and 3 months after rehabilitation.
2. Patient compliance instruction
1) Antihypertensive agents
Vital signs such as blood pressure, pulse and body temperature measured by Internet of Things (IoT) devices are shared with medical staffs. Medical staffs discussed the data and adjust the dosage of antihypertensive agents when necessary. The efficacy of the system is evaluated by measuring the vital signs before and after intervention.
2) Hypnotics
Quality of sleep is quantitatively evaluated by IoT-based bed sensor which can measure sleep time, awaking time, sleep latency, body movements and number of breaths during sleep. Medical staffs discuss the data and adjust the dosage of hypnotic when necessary. The efficacy of the system is evaluated by the quantitative sleep indices before and after the intervention.
3) Laxatives
The information of defecation frequency and fecal property is recorded by ICT devices and shared with medical staffs. Medical staffs discussed the data and adjust the dosage of laxative when necessary. The efficacy of the system is evaluated by the defecation frequency and fecal property before and after the intervention.
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
1. Rehabilitation
Medical staffs check the patients' status by telemedicine system and IoT/ICT devices and advise to patients every month at two weeks after the initial intervention.
2. Patient compliance instruction
Medical staff adjusted the dosage of drugs every month based on the data measured by IoT/ICT devices.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Rehabilitation
Patients who are needed rehabilitations
2. Patient compliance instruction
Patients with hypertension, insomnia or constipation
Key exclusion criteria
Patients who are judged to be uneligible for this study due to severe complication or other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akitoshi |
| Middle name | |
| Last name | Yoshida |
Organization
Asahikawa Medical University
Division name
President of Asahikawa Medical University
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-65-2111
pyoshida@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Moriichi |
Organization
Asahikawa Medical University
Division name
Joint Research Department of Telemedicine and Telecare
Zip code
078-8510
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2693
Homepage URL
morimori@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Kanamic Network Co., Ltd.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committ
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido 078-8510, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.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
| 2020 | Year | 08 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047221
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