Unique ID issued by UMIN | UMIN000006839 |
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Receipt number | 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 11:58:41 |
Home Telemonitoring Study for Patients with Chronic Heart Failure
HOMES-HF
Home Telemonitoring Study for Patients with Chronic Heart Failure
HOMES-HF
Japan |
chronic heart failure
Cardiology |
Others
NO
To investigate the effectiveness of home telemonitoring compared to usual care in reducing re-hospitalization and mortality in patients with chronic heart failure.
Efficacy
Confirmatory
Pragmatic
Not applicable
time to all-cause death or readmission for heart failure decompensation
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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Behavior,custom |
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
usual care
20 | years-old | <= |
Not applicable |
Male and Female
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
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
420
1st name | |
Middle name | |
Last name | Koichi Node |
Saga university
cardiovascular medicine
5-1-1 Nabeshima Saga, Japan
0952-34-2364
node@cc.saga-u.ac.jp
1st name | |
Middle name | |
Last name | Norihiko Kotooka |
Saga university
cardiovascular medicine
5-1-1 Nabeshima Saga, Japan
0952-34-2364
kotooka@cc.saga-u.ac.jp
Department of Cardiovascular Medicine, Saga university
Health Sciences Research Grants from the Japanese Ministry of Health, Labour and Welfare
Japanese Governmental office
Japan
Hokkaido university
Hyogo college of medicine
National Cerebral and Cardiovascular Center
NO
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)
2011 | Year | 12 | Month | 12 | Day |
Unpublished
No longer recruiting
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 01 | Month | 01 | Day |
2014 | Year | 08 | Month | 31 | Day |
2011 | Year | 12 | Month | 05 | Day |
2017 | Year | 12 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007983
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