UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051878 |
|---|---|
| Receipt number | R000059190 |
| Scientific Title | Effectiveness of a home management program for heart failure patients with physical frailty: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/09 21:36:55 |
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Basic information
Public title
Effectiveness of a home management program for heart failure patients with physical frailty: A Multicenter Randomized Controlled Trial.
Acronym
HomeReha study 2
Scientific Title
Effectiveness of a home management program for heart failure patients with physical frailty: A Randomized Controlled Trial.
Scientific Title:Acronym
HomeReha study 2
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of comprehensive home-based cardiac rehabilitation for heart failure patients with physical frailty in a multicenter setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the 6-minute walking test
Key secondary outcomes
Cardiovascular Events
Changes in J-CHS
Change in SPPB
Change in number of steps
Change in KCCQ
Change in European Heart Failure Self-Care Behavior Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Wear a wearable device for 180 days to manage activity while providing disease management, exercise and nutritional guidance
Interventions/Control_2
Wear the wearable device for 180 days under your own supervision
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic Heart failure patients(Stage C/D)
2. Age 18 and older
3. Physical frailty patients with pre-frail or higher(J-CHS)
Key exclusion criteria
1. Patients with contraindications to exercise therapy
2. Acute coronary syndrome within 1 week
3. End-stage heart failure (inotropic drugs administered at home, LVAD)
4. Patients at high risk of lethal arrhythmias
5. Severely cognitively impaired patients
6. Patients who have difficulty walking independently indoors
7. Patients who cannot be discharged home
8. Patients who do not have their own smartphone
9. Patients who requested outpatient rehabilitation at least twice a week
10. Patients with a 6-minute walking distance of 550 m or more
11. Patients who are judged to be difficult to participate in the study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5360
ide.tomomi.117@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Nagatomi |
Organization
Kyushu University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5862
Homepage URL
nagatomi.yuta.532@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 10 | 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
| 2023 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059190
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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