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

This study has been withdrawn prior to enrollment.
(logistic and financial accounting reasons concerning the delivery of the medication device to the patients and financing rules for participating pharmacies.)
Sponsor:
Collaborator:
TweeSteden Hospital, Tilburg, the Netherlands
Information provided by (Responsible Party):
Nina Kupper PhD, University of Tilburg
ClinicalTrials.gov Identifier:
NCT01347528
First received: April 29, 2011
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 University of Tilburg:

Primary Outcome Measures:
  • Change in medication adherence [ Time Frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Course of disease severity [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347528

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

No publications provided by University of Tilburg

Additional 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
Study First Received: April 29, 2011
Last Updated: December 6, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University of Tilburg:
Medication adherence
Heart failure
Telemonitoring
Determinants of adherence

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014