UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Home Telemonitoring Study for Patients with Chronic Heart Failure
Title of the study (Brief title)	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	Koichi Node
Organization	Saga university
Division name	cardiovascular medicine
Address	5-1-1 Nabeshima Saga, Japan
TEL	0952-34-2364
Email	node@cc.saga-u.ac.jp

Public contact
Name of contact person	Norihiko Kotooka
Organization	Saga university
Division name	cardiovascular medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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