UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of Telemonitoring after discharge of hospitalized older patients
Acronym	Feasibility study of Telemonitoring after discharge of hospitalized older patients
Scientific Title	Feasibility study of Telemonitoring after discharge of hospitalized older patients
Scientific Title:Acronym	Feasibility study of Telemonitoring after discharge of hospitalized older patients
Region	Japan

Condition
Condition	Older adults discharged from geriatric medicine
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to show the feasibility of telemonitoring in older adults after discharge, and to show change of their health literacy and quality of life through telemonitoring.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adherence of telemonitoring
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	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Subjects receive telemonitoring for one month after discharge.
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	65 years-old <=
Age-upper limit	150 years-old >=
Gender	Male and Female
Key inclusion criteria	Older adults discharge from geriatric medicine ward
Key exclusion criteria	terminally ill patient
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Umegaki
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Community Healthcare and Geriatrics,
Zip code	018982
Address	65-banchi, Tsurumai-cho, Showa-ku,Nagoya-shi,Aichi
TEL	052-744-2364
Email	umegaki@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Kanamori
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Community Healthcare and Geriatrics,
Zip code	018982
Address	65-banchi, Tsurumai-cho, Showa-ku,Nagoya-shi,Aichi
TEL	052-744-2364
Homepage URL
Email	t-kanamori@rctoyota.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Grant-in-Aid for challenging Exploratory Research
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	Medical Research Ethics Committee of Nagoya University
Address	65-banchi, Tsurumai-cho, Showa-ku,Nagoya-shi,Aichi
Tel	052-789-4355
Email	t-kanamori@rctoyota.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 02 Month 01 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	2019 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2022 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	2019 Year 12 Month 09 Day
Last modified on	2019 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044276