UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042601 |
|---|---|
| Receipt number | 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 19:20:14 |
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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
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
iwaken@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048623
