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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347528
Recruitment Status : Withdrawn (logistic and financial accounting reasons)
First Posted : May 4, 2011
Last Update Posted : December 3, 2015
The Elisabeth-TweeSteden Hospital
Information provided by (Responsible Party):
Nina Kupper PhD, University of Tilburg

April 29, 2011
May 4, 2011
December 3, 2015
October 2011
January 2012   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01347528 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Heart Failure
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
  • Experimental: TELEmonitoring intervention
    Intervention: Behavioral: Medication Adherence Support System (MASS)
  • No Intervention: Usual care
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2012
January 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
UVT MP 002
Not Provided
Not Provided
Nina Kupper PhD, University of Tilburg
University of Tilburg
The Elisabeth-TweeSteden Hospital
Principal Investigator: Nina Kupper Tilburg University, The Netherlands
University of Tilburg
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP