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

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ClinicalTrials.gov Identifier: NCT01347528
Recruitment Status : Withdrawn (logistic and financial accounting reasons)
First Posted : May 4, 2011
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Heart Failure Behavioral: Medication Adherence Support System (MASS)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : October 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Change in self-care behavior and Quality of Life [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]
  2. 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

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


Eligibility Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347528


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nina Kupper PhD, Nina Kupper, PhD, University of Tilburg
ClinicalTrials.gov Identifier: NCT01347528     History of Changes
Other Study ID Numbers: UVT MP 002
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases