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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
| WGK Limburg | UNKNOWN |
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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). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient.
The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring group | Experimental | Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology |
|
| Control group | No Intervention | usual care, without telemonitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Pressure Monitor, medication dispenser, telemonitoring technology | Device | The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean medication doses | Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 12 weeks. | week 12 |
| Mean medication doses | Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 6 months | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication titration | Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months | up to one year |
| All-cause mortality | All-cause mortality |
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Inclusion Criteria:
- Age ≥ 50
Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt
The patient has to be able to live independently or in a service flat
The diagnosis of heart failure or severe myocardial infarction has to be done after September 1, 2013 according to:
The general practitioner had to give his approval for the installation of telemonitoring On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Vandervoort, prof. dr. | Ziekenhuis Oost-Limburg | Principal Investigator |
| Brenda Aendekerk, MSc | Wit Gele Kruis Limburg, Genk, Belgium | Study Director |
| Valerie Storms, dr. | Hasselt University | Study Director |
| Lars Grieten, dr. | Hasselt University | Principal Investigator |
| Christophe Smeets, MSc | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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|
| Up to one year |
| All cardio-related hospitalisations (number and time) |
| Up to one year |
| All heart failure hospitalisations |
| Up to one year |
| Number of medical practitioner-patient contacts |
| Up to one year |
| Number of (telephone) contacts, registered by the heart failure nurse | Number of (telephone) contacts, registered by the heart failure nurse | Up to one year |
| Number of (telephone) contacts for the encouragement of medication compliance | Number of (telephone) contacts for the encouragement of medication compliance | Up to one year |
| Evolution of heart failure and comorbidities |
| up to one year |
| Quality of life according to the HeartQoL questionnaire | day 1, month 12 |
| Satisfaction survey | Satisfaction survey about the received care (anonymous) | month 12 |