Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Medication Adherence Support System (MASS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable systolic heart failure 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: Age younger than 50 years 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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TELEmonitoring intervention<br> | Behavioral: Medication Adherence Support System (MASS)<br>* 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.<br>* Other names: PICO® by Vitaphone Nederland BV;|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Heart failure, Telemonitoring, Determinants of adherence