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logistic and financial accounting reasons
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| Name | Class |
|---|---|
| The Elisabeth-TweeSteden Hospital | OTHER |
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TELEMED-HF is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic Medication Adherence Support System (MASS) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TELEmonitoring intervention | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Adherence Support System (MASS) | Behavioral | The intervention consists of the use of an electronic Medication Adherence Monitor for a 6-month period as well as 2 visits to the heart failure outpatient clinic of the TweeSteden hospital (usual care). This monitor (a) dispenses all prescribed medication in the right dosage at the specified time, (b) reminds patients to take their medications through an alarm, sms or voicemail service and records adherence, and (c) sends critical data about non-adherence to the heart failure nurse, via a web application (CarebyWeb). The Medication Adherence Monitor is provided to the patient by the hospital pharmacy, including an instruction how to use the device. After the intervention patients return to usual care only. We expect a training effect, with continued improved adherence in the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence | Objective medication adherence will be assessed using the MASS monitor output collected in a web-based application and the refill rates provided by the patients' pharmacies. | Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months |
| Change in number of hospitalizations (costs) | A cost-benefit analysis will be assessed by means of the TiC-P questionnaire and event rate (and related DBC (diagnosis treatment combination, the Dutch system to allocate costs to treatments of specific patient groups)). The TiC-P questionnaire will enable us to compare healthcare consumption in the intervention and control group. | Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-care behavior and Quality of Life | Baseline, 6 months, 12 months, and 18 months | |
| Course of disease severity | Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Kupper | Tilburg University, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TweeSteden Hospital | Tilburg | North Brabant | 5042AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21999637 | Derived | Kessing D, Denollet J, Widdershoven J, Kupper N. Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial. Trials. 2011 Oct 14;12:227. doi: 10.1186/1745-6215-12-227. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| Baseline, 6 months, 12 months, and 18 months |
| Change in psychological variables | Type D personality, depression, anxiety | Baseline, 6 months, 12 months, and 18 months |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |