UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032780 |
|---|---|
| Receipt number | R000037368 |
| Scientific Title | Effects of Smartphone Application for Self-Care Support on Clinical Outcomes in Patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2022/03/26 16:15:19 |
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Basic information
Public title
Effects of Smartphone Application for Self-Care Support on Clinical Outcomes in Patients with Chronic Heart Failure
Acronym
AppCare-HF Study
Scientific Title
Effects of Smartphone Application for Self-Care Support on Clinical Outcomes in Patients with Chronic Heart Failure
Scientific Title:Acronym
AppCare-HF Study
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether self-care support application for smartphone could improve clinical outcomes in chronic heart failure patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause death, hospitalization for heart failure worsening, and improvement of quality of life (composite endpoints) for 12 months of study period
Key secondary outcomes
1) All-cause death
2) Heart failure-related death
3) All-cause hospitalization
4) Hospitalization for heart failure worsening
5) Number of days before first hospitalization
6) Number of hospitalization and length of hospital stay
7) Number of extraordinary visit due to bad physical condition
8) Quality of life
9) Plasma levels of BNP (or NT-proBNP)
10) NYHA class
11) Neutritional status
12) Self-care behavior ability
13) Self-efficacy
14) Anxiety
15) Medical cost
16) Predictors of onset of cardiovascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Smartphone app. group
Interventions/Control_2
Usual care group (Control group)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure who have a history of hospital admission due to congestive heart failure diagnosed by the Framingham criteria
Key exclusion criteria
1) A patient who cannot use smartphone application
2) A patient who has a history of hospitalization within the past 1 month
3) A patient who has a history of surgery including percutaneous coronary intervention within the past 3 months
4) A patient with a malignant disease except for a complete cure
5) A patient with severe renal failure (eGFR<15mL/min/1.73m2) or a dialysis patient
6) A patient with severe aortic valve stenosis
7) A patient with ventricular assist device (VAD)
8) A patient who has a plan to hospitalization due to surgery or examination at the time of study participation
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
t-yokota@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University
Division name
Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology (Japan)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
t-yokota@med.hokudai.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
| 2018 | Year | 05 | Month | 30 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037368
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