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Heart Failure Educational and Follow up Platform (HELP)
This study is ongoing, but not recruiting participants.
Sponsor:
Centre Hospitalier René Dubos
Information provided by (Responsible Party):
Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier:
NCT02110433
First received: March 7, 2014
Last updated: May 15, 2017
Last verified: May 2017
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Purpose
Heart failure is a serious and common disease. HF is marked by a high rate of preventable hospitalizations through proper care. As such, it is a key target for telemedicine programs. However, currently published data are inconclusive. Investigators propose a multicenter randomized study of innovative telemedicine involving the usual patient monitoring daily weight monitoring, clinical signs and in one of three groups in our study of BNP testing in the patient's home all associated with a regular education reinforcement. The objective is to identify early cardiac decompensation to allow to treat ambulatory and thus prevent the occurrence of more serious events such as death or rehospitalization.
| Condition | Intervention |
|---|---|
| Chronic Heart Failure | Device: Placebo group Device: Cordiva System (R) Device: BNP heartcheck |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Supportive Care |
| Official Title: | Heart Failure Educational and Follow up Platform |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier René Dubos:
Primary Outcome Measures:
- Primary end point is a composite end point including unplanned hospitalizations for CHF with hospital stay > 1 day / all-cause death / non-programmed emergency department admission related to CHF [ Time Frame: Follow up 12 months after inclusion ]
Secondary Outcome Measures:
- emergency admission. [ Time Frame: 12 months ]
- Number of all cause death. [ Time Frame: 12 months ]
- Number of HF hospitalizations [ Time Frame: 12 months ]
- Adherence to the strategy [ Time Frame: 12 months ]defined with at least 75% of the measurements done by the patient
- Quality of life. [ Time Frame: 12 months ]
- False positive induced by the system (visits to the GP or cardiologist proposed by the telemonitoring system without final evidence of HF decompensation and without increase of diuretics ) [ Time Frame: 12 months ]
- False positive induced by the system [ Time Frame: 12 months ]visits to the GP or cardiologist proposed by the Medical cost and efficience of the technique
- Cost of the different strategies [ Time Frame: 12 months ]
- Cost efficacy of the different strategies [ Time Frame: 12 months ]cost of hospitalization reported in the national health cost system / cost of transportation / cost of medical therapy (oral) / cost of medical visits / cost of the heartcheck monitoring system as mentioned by Alere(R)
| Enrollment: | 330 |
| Study Start Date: | December 2013 |
| Estimated Study Completion Date: | October 2017 |
| Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo group
Patients will be managed per consensus guidelines Clinicians could see the patients as many times as necessary in order to optimize their therapy and could make BNP measurement (but not using Home BNP monitoring)
|
Device: Placebo group
patient will be managed as recommended by ESC guidelines and follow up will be in accordance to ESC recommendations
|
|
Experimental: Cordiva System (R)
Patient will see their cardiologist every three months and benefit from telemonitoring of their weight and general well being through a specific communicant device.
|
Device: Cordiva System (R)
Patients have to answer to 8 specific binary questions based on the main precipitating factors for decompensation and measure their body weight every day. If not they will be contact after two missing measures. Patient will be contact by phone call every month in order to reinforce the initial patient therapeutic education and patient-'s compliance. Patient have access to specific printed documents and to a specific web based platform where he can find some PowerPoint presentation on CHF aetiology, signs and therapy and where he can try to answer to monthly quiz in whom questions are based on key messages about CHF according to guidelines and consensus paper on patient therapeutic education.
|
|
Active Comparator: BNP and Cordiva (R) monitoring system
In this group, patients and doctors have access to the platform detailed above (Cordiva (R) monitoring system) and had also access to BNP home monitoring (BNP heartcheck).
|
Device: Cordiva System (R)
Patients have to answer to 8 specific binary questions based on the main precipitating factors for decompensation and measure their body weight every day. If not they will be contact after two missing measures. Patient will be contact by phone call every month in order to reinforce the initial patient therapeutic education and patient-'s compliance. Patient have access to specific printed documents and to a specific web based platform where he can find some PowerPoint presentation on CHF aetiology, signs and therapy and where he can try to answer to monthly quiz in whom questions are based on key messages about CHF according to guidelines and consensus paper on patient therapeutic education.
Device: BNP heartcheck
Patients had to measure the BNP plasma level using Alere home based BNP device heartcheck in a weekly basis in order to follow this parameter up. In case of clinical signs of CHF or a significant weight increase identified by the tele monitoring or the patient, the nurse will ask to the patient to do an extra measurement of home BNP testing in order to exclude a CHF decompensation (BNP < 100 pg/ml or remaining stable (< 30% increase).
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Heart failure diagnosed on a first hospitalization for acute exacerbation during the last twelve months, without high age limit
- Men or women
- More than 18 years old
- Minimal knowledge of the French language (patient or his relatives)
- The patient need to fill an informed written consent
- Patient resides or is treated in Ile de France
- Patient is insured under the social security system
Exclusion Criteria:
- Myocardial infarction or revascularization or Heart Valve Surgery < 3 months
- Inability to execute the feasibility test
- Major cognitive disorders do not allow access to the platform
- Patient does not have the necessary autonomy to use the equipment
- Sensitive subject, under Article L32 of the Code of Public Health
- Patient enrolled in another clinical trial
- Renal failure with creatininemia clearance (cockcroft) <15 ml/min
- 24h/day oxygen
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02110433
Please refer to this study by its ClinicalTrials.gov identifier: NCT02110433
Locations
| France | |
| Centre Hospitalier René DUBOS | |
| Pontoise, Ile de France, France, 95303 | |
| Victor Dupouy Hospital | |
| Argenteuil, France, 95 | |
| Sud francilien Hospital | |
| Corbeil-Essonnes, France, 91106 | |
| Henri-Mondor Hospital | |
| Créteil, France, 94 | |
| Simone Veil Hospital | |
| Eaubonne, France, 95 | |
| Bernard Clinic | |
| Ermont, France, 95 | |
| Gonesse Hospital | |
| Gonesse, France | |
| Versailles Hospital | |
| Le Chesnay, France, 78157 | |
| Orsay Hospital | |
| Longjumeau, France, 91160 | |
| Meaux Hospital | |
| Meaux, France, 77104 | |
| Sainte Marie Clinic | |
| Osny, France, 95 | |
| Georges Pompidou University Hospital | |
| Paris, France, 75015 | |
| Mutualiste Montsouris Institute | |
| Paris, France, 75 | |
| Turin Clinic | |
| Paris, France, 75 | |
| Poissy-Saint-Germain-en-Laye Hospital | |
| Saint-Germain-en-Laye, France, 78100 | |
Sponsors and Collaborators
Centre Hospitalier René Dubos
Investigators
| Principal Investigator: | Patrick JOURDAIN | René Dubos Hospital (Pontoise-France) |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Hospitalier René Dubos |
| ClinicalTrials.gov Identifier: | NCT02110433 History of Changes |
| Other Study ID Numbers: |
CHRD0414 2013A0089936 ( Other Identifier: IDRCB ) |
| Study First Received: | March 7, 2014 |
| Last Updated: | May 15, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Centre Hospitalier René Dubos:
|
chronic heart failure BNP telemedicine telemonitoring |
weight education self management cost effectiveness |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on July 17, 2017