Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
NCT ID: NCT01347528
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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TELEmonitoring intervention
Medication Adherence Support System (MASS)
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.
Usual care
No interventions assigned to this group
Interventions
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Medication Adherence Support System (MASS)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New York Heart Association functional class II-III, with a decreased pump function (left ventricular ejection fraction (LVEF) \<45%)
* Titrated to the most optimal doses of ACE-inhibitor or Angiotensin Receptor Blocker, and beta-blocker
* Receiving stable doses of at least 3 heart failure medications (at multiple times during the day) for 1 month with no plans to add or adjust heart failure medications or titrate further in the immediate future.
Exclusion Criteria
* Diastolic heart failure (intact pump function)
* Myocardial infarction, invasive treatment (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), or hospitalization within 1 month prior to inclusion
* Life-threatening comorbid conditions (e.g., cancer)
* Diminished mental capacities (suspected cognitive decline will be confirmed by a mini mental state examination (MMSE))
* History of psychiatric disorders apart from affective disorders (depression and anxiety disorders)
50 Years
ALL
No
Sponsors
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The Elisabeth-TweeSteden Hospital
OTHER
Tilburg University
OTHER
Responsible Party
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Nina Kupper PhD
Nina Kupper, PhD
Principal Investigators
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Nina Kupper
Role: PRINCIPAL_INVESTIGATOR
Tilburg University, The Netherlands
Locations
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TweeSteden Hospital
Tilburg, North Brabant, Netherlands
Countries
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References
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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.
Other Identifiers
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UVT MP 002
Identifier Type: -
Identifier Source: org_study_id