Study Stopped
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Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
TELEMED-HF
A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2011
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 3, 2015
December 1, 2015
3 months
April 29, 2011
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in medication adherence
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)
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 Outcomes (3)
Change in self-care behavior and Quality of Life
Baseline, 6 months, 12 months, and 18 months
Course of disease severity
Baseline, 6 months, 12 months, and 18 months
Change in psychological variables
Baseline, 6 months, 12 months, and 18 months
Study Arms (2)
TELEmonitoring intervention
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age younger than 50 years
- Diastolic heart failure (intact pump function)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tilburg Universitylead
- The Elisabeth-TweeSteden Hospitalcollaborator
Study Sites (1)
TweeSteden Hospital
Tilburg, North Brabant, 5042AD, Netherlands
Related Publications (1)
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.
PMID: 21999637DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Kupper
Tilburg University, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nina Kupper, PhD
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 4, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 3, 2015
Record last verified: 2015-12