Clinical trial NCT01347528: Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
Official title: A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Keywords: Medication adherence
Heart failure
Telemonitoring
Determinants of adherence
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: The Elisabeth-TweeSteden Hospital
First posted: 2011-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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)

Primary outcomes:
measure: Change in medication adherence
timeFrame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
measure: Change in number of hospitalizations (costs)
timeFrame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary outcomes:
measure: Change in self-care behavior and Quality of Life
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Course of disease severity
timeFrame: Baseline, 6 months, 12 months, and 18 months
measure: Change in psychological variables
timeFrame: Baseline, 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: TweeSteden Hospital
state: Noord-Brabant
Study officials:
affiliation: Tilburg University, The Netherlands
name: Nina Kupper
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.