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

This study has been withdrawn prior to enrollment.
(logistic and financial accounting reasons)
The Elisabeth-TweeSteden Hospital
Information provided by (Responsible Party):
Nina Kupper PhD, University of Tilburg Identifier:
First received: April 29, 2011
Last updated: December 1, 2015
Last verified: December 2015
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.

Condition Intervention
Heart Failure Behavioral: Medication Adherence Support System (MASS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)

Resource links provided by NLM:

Further study details as provided by Nina Kupper PhD, University of Tilburg:

Primary Outcome Measures:
  • Change in medication adherence [ Time Frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months ]
    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.

  • Change in number of hospitalizations (costs) [ Time Frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months ]
    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.

Secondary Outcome Measures:
  • Change in self-care behavior and Quality of Life [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]
  • Course of disease severity [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]
    Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms

  • Change in psychological variables [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]
    Type D personality, depression, anxiety

Enrollment: 0
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TELEmonitoring intervention Behavioral: 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 Name: PICO® by Vitaphone Nederland BV
No Intervention: Usual care


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01347528

TweeSteden Hospital
Tilburg, Noord-Brabant, Netherlands, 5042AD
Sponsors and Collaborators
University of Tilburg
The Elisabeth-TweeSteden Hospital
Principal Investigator: Nina Kupper Tilburg University, The Netherlands
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nina Kupper PhD, Nina Kupper, PhD, University of Tilburg Identifier: NCT01347528     History of Changes
Other Study ID Numbers: UVT MP 002
Study First Received: April 29, 2011
Last Updated: December 1, 2015

Keywords provided by Nina Kupper PhD, University of Tilburg:
Medication adherence
Heart failure
Determinants of adherence

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on July 21, 2017