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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042601
Receipt No. R000048623
Scientific Title QuaLity hOme-based rehabilitatioN and remote monitorinG in Elderly patients with heart and/or respiratory failure to preVent fraIlty, readmission and morTalitY
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/30

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Basic information
Public title Home-based rehabilitation in elderly heart failure and respiratory failure
Acronym LONGEVITY
Scientific Title QuaLity hOme-based rehabilitatioN and remote monitorinG in Elderly patients with heart and/or respiratory failure to preVent fraIlty, readmission and morTalitY
Scientific Title:Acronym LONGEVITY
Region
Japan

Condition
Condition pneumonia, respiratory failure and heart failure
Classification by specialty
Medicine in general Cardiology Pneumology
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this trial is to determine whether supervised home-based exercise training and remote patient monitoring (RPM) could reduce mortality and readmission in elderly patients hospitalized for acute decompensated heart failure (ADHF) or respiratory failure including pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality or rehospitalization during 6 months after the index hospitalization
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Quality home-based rehabilitation
Interventions/Control_2 Remote monitoring using electronic device
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

Not applicable
Gender Male and Female
Key inclusion criteria Elderly patients (>= 65 years old) who were admitted to our hospital due to respiratory failure including pneumonia or heart failure
Key exclusion criteria Patients who did not agree to participate.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Kitai
Organization Kobe City Medical Center General Hospital
Division name Department of Cardiovascular Medicine
Zip code 6500047
Address 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Email t-kitai@kcho.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Iwata
Organization Kobe City Medical Center General Hospital
Division name Department of Rehabilitation
Zip code 6500047
Address 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Homepage URL
Email iwaken@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Japanese Physical Therapy Association
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 Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe, Japan
Tel 078-302-4321
Email t-kitai@kcho.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 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 121
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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 30 Day
Date of IRB
2018 Year 01 Month 15 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 Year 12 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 11 Month 30 Day
Last modified on
2020 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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