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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032780
Receipt No. 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 2019/02/18

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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
Middle name
Last name Takashi Yokota
Organization Hokkaido University
Division name Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine
Zip code
Address Kita-15 Nishi-7, Kita-Ku, 060-8638 Sapporo, Japan
TEL 011-706-6973
Email t-yokota@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yokota
Organization Hokkaido University
Division name Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine
Zip code
Address Kita-15 Nishi-7, Kita-Ku, 060-8638 Sapporo, Japan
TEL 011-706-6973
Homepage URL
Email t-yokota@med.hokudai.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency; Ministry of Education, Culture Sports, Science and Technology-Japan
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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
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
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037368

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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