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

December 1, 2015 updated by: Nina Kupper PhD, Tilburg University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands, 5042AD
        • TweeSteden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
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 Names:
  • PICO® by Vitaphone Nederland BV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
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.
Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-care behavior and Quality of Life
Time Frame: Baseline, 6 months, 12 months, and 18 months
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
Baseline, 6 months, 12 months, and 18 months
Change in psychological variables
Time Frame: Baseline, 6 months, 12 months, and 18 months
Type D personality, depression, anxiety
Baseline, 6 months, 12 months, and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tilburg University

Collaborators

The Elisabeth-TweeSteden Hospital

Investigators

  • Principal Investigator: Nina Kupper, Tilburg University, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVT MP 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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