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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006839
Receipt No. R000007983
Scientific Title Home Telemonitoring Study for Patients with Chronic Heart Failure
Date of disclosure of the study information 2011/12/12
Last modified on 2017/12/07

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Basic information
Public title Home Telemonitoring Study for Patients with Chronic Heart Failure
Acronym HOMES-HF
Scientific Title Home Telemonitoring Study for Patients with Chronic Heart Failure
Scientific Title:Acronym HOMES-HF
Region
Japan

Condition
Condition chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of home telemonitoring compared to usual care in reducing re-hospitalization and mortality in patients with chronic heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes time to all-cause death or readmission for heart failure decompensation
Key secondary outcomes 1. time to all-cause death
2. time to cardiovascular death
3. time to all-cause readmissions
4. time to cardiovascular readmissions
5. time to readmissions for heart failure decompensation
6. changes in New York Heart Association functional class (NYHA)
7. cost effectiveness
8. changes in left ventricular ejection fraction (EF)
9. changes in N-terminal pro-BNP (NT-proBNP), high-sensitivity C-reactive protein (hsCRP), pentraxin3 (PTX3), adipose triglyceride lipase (ATGL), high-sensitivity troponin T (hsTnT), receptor for advanced glycation end products (RAGE), and high-molecular weight adiponectin
10. cognitive function (Mini Mental State Examination; MMSE)
11. patient's self efficacy (General Self Efficacy Scale; GSES)
12. heart failure related quality of life (QOL) as measured by the Minnesota Living with Heart Failure (MLWHF)
13. adherance for medication
14. anxiety and deession as measured by Patient Health Questionnaire 9 (PHQ-9)

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 automated physiological monitoring including daily body weight, blood pressure, and pulse rate by web linked home telemonitoring system, and patient education by nurse with the use of the home telemonitoring system in every regular hospital visit
Interventions/Control_2 usual care
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 currently scheduled for discharge or discharged within 30 days from heart failure hospitalization; New York Heart Association functional class II or III; age 20 or older
Key exclusion criteria currently implanted or scheduled for pacemaker, implantable cardioverter defibrillator, or bi-ventricular pacemaker (with defibrillator), because the scale for present study emits a faint alternating current to measure body impedance; advanced renal insufficiency (i.e. serum creatinine 3.0 mg/ld or more); severe liver dysfunction; planned percutaneous coronary intervention or coronary artery bypass grafting; limited life expectancy because of malignant disease; severe cognitive impairment or mental illness; pregnancy; deemed unable to stand on a scale safely; no access to a telephone line
Target sample size 420

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Node
Organization Saga university
Division name cardiovascular medicine
Zip code
Address 5-1-1 Nabeshima Saga, Japan
TEL 0952-34-2364
Email node@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihiko Kotooka
Organization Saga university
Division name cardiovascular medicine
Zip code
Address 5-1-1 Nabeshima Saga, Japan
TEL 0952-34-2364
Homepage URL
Email kotooka@cc.saga-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Saga university
Institute
Department

Funding Source
Organization Health Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hokkaido university
Hyogo college of medicine
National Cerebral and Cardiovascular Center
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 北海道大学病院(北海道)
東北大学病院(宮城県)
自治医科大学さいたま医療センター(埼玉県)
自治医科大学病院(栃木県)
獨協医科大学病院(栃木県)
日本医科大学千葉北総病院(千葉県)
北里大学病院(神奈川県)
東邦大学医療センター大橋病院(東京都)
聖路加国際病院(東京都)
国立循環器病研究センター病院(大阪府)
兵庫医科大学病院(兵庫県)
兵庫県立尼崎病院(兵庫県)
勝谷医院(兵庫県)
鳥取大学病院(鳥取県)
島根大学病院(島根県)
済生会福岡総合病院(福岡県)
九州厚生年金病院(福岡県)
古賀病院21(福岡県)
佐賀県立病院好生館(佐賀県)
ひらまつ病院(佐賀県)
江頭内科循環器内科(佐賀県)
ひさのう循環器科内科(佐賀県)
済生会唐津病院(佐賀県)
伊万里市立市民病院(佐賀県)
大分大学病院(大分県)
垂水市立医療センター垂水中央病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 12 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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 08 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
2011 Year 12 Month 05 Day
Last modified on
2017 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007983

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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