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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
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.
TweeSteden Hospital
Tilburg, North Brabant, Netherlands
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.
Time frame: 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.
Time frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Change in self-care behavior and Quality of Life
Time frame: 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
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in psychological variables
Type D personality, depression, anxiety
Time frame: Baseline, 6 months, 12 months, and 18 months
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