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

Not Applicable

Withdrawn

• Conditions: Heart Failure
• Interventions: Behavioral: Medication Adherence Support System (MASS)

• Registration Number: NCT01347528
• Lead Sponsor: Tilburg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-04
• Study Start: 2011-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TELEmonitoring intervention	Medication Adherence Support System (MASS)	-

Primary Outcome Measures

Name	Time	Method
Change in medication adherence	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.
Change in number of hospitalizations (costs)	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

Name	Time	Method
Change in psychological variables	Baseline, 6 months, 12 months, and 18 months	Type D personality, depression, anxiety
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	Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms

Trial Locations

Locations (1)

TweeSteden Hospital; 🇳🇱 Tilburg, Noord-Brabant, Netherlands