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

Heart Failure Clinical Trial

— TELEMED-HF  

Official title:

A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01347528
• Other study ID #: UVT MP 002
• Status: Withdrawn
• Phase: N/A
• First received: April 29, 2011
• Last updated: December 1, 2015
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2015
• Source: University of Tilburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

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.

Locations

Country	Name	City	State
Netherlands	TweeSteden Hospital	Tilburg	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
University of Tilburg	The Elisabeth-TweeSteden Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change in self-care behavior and Quality of Life		Baseline, 6 months, 12 months, and 18 months	No
Secondary	Course of disease severity	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	No
Secondary	Change in psychological variables	Type D personality, depression, anxiety	Baseline, 6 months, 12 months, and 18 months	No