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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
| Jessa Hospital | OTHER |
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This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.
When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care).
The telemonitoring interference in the other study arm consists of a smartphone application to register medication intake and to transmit the data of an automatic blood pressure device and a balance to a central platform. The goal is to improve medication uptitration (angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB)) in heart failure patients and to improve medication compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental | Recieve a smartphone with an application to coach them, a blood pressure monitor and scale. |
|
| Control group | No Intervention | Control group (usual care, without telemonitoring) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Device | The telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean medication doses | Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 3 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication titration | Mean daily doses of ACE-inhibitors/ARB's, β blokkers and Aldosteron antagonists after 6 months. This is estimated by registration of the types of medication, the corresponding doses and the frequency of intake. | after month 6 |
| All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vandervoort Pieter, MD, PhD | Ziekenhuis Oost-Limburg | Study Director |
| Paul Dendale, MD, PhD | Jessa Ziekenhuis, Hasselt, Belgium | Study Director |
| Jo Ravelingen | Remedus, Aartselaar, Belgium | Study Director |
| Peter Van Vooren | Fifthplay, Antwerpen, Belgium | Study Director |
| Valerie Storms, PhD | Mobile Health Unit, Hasselt University, Hasselt, Belgium | Study Director |
| Lars Grieten, PhD | Mobile Health Unit, Hasselt University, Hasselt, Belgium | Principal Investigator |
| Christophe Smeets, PhD student | Mobile Health Unit, Hasselt University, Hasselt, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium | |||
| Jessa Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31758773 | Derived | Smeets CJ, Storms V, Vandervoort PM, Dreesen P, Vranken J, Houbrechts M, Goris H, Grieten L, Dendale P. A Novel Intelligent Two-Way Communication System for Remote Heart Failure Medication Uptitration (the CardioCoach Study): Randomized Controlled Feasibility Trial. JMIR Cardio. 2018 Apr 4;2(1):e8. doi: 10.2196/cardio.9153. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
All-cause mortality |
| up to month 6 |
| All cardio related hospitalizations (number and time) |
| up to month 6 |
| All heart failure hospitalizations |
| up to month 6 |
| Number of medical practitioner-patient contacts |
| up to month 6 |
| Number of (telephone) contacts, registered by the heart failure nurse | Number of (telephone) contacts, registered by the heart failure nurse | up to month 6 |
| Number of (telephone) contacts for the encouragement of medication compliance and parameter (Remedus) | Number of (telephone) contacts for the encouragement of medication compliance (Remedus) | up to month 6 |
| Evolution of heart failure and comorbidities |
| up to month 6 |
| Quality of life according to the HeartQoL questionnaire | Quality of life according to the HeartQoL questionnaire | day 1, month 6 |
| Satisfaction survey | Satisfaction survey about the received care (anonymous) for the cardiocoach group. | month 6 |
| Hasselt |
| 3500 |
| Belgium |