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

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Medication Adherence Support System (MASS)
Sponsored by
Tilburg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Medication adherence, Heart failure, Telemonitoring, Determinants of adherence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • TweeSteden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TELEmonitoring intervention

Usual care

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in self-care behavior and Quality of Life
Course of disease severity
Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms
Change in psychological variables
Type D personality, depression, anxiety

Full Information

First Posted
April 29, 2011
Last Updated
December 1, 2015
Sponsor
Tilburg University
Collaborators
The Elisabeth-TweeSteden Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01347528
Brief Title
Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
Acronym
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
logistic and financial accounting reasons
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tilburg University
Collaborators
The Elisabeth-TweeSteden Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Medication adherence, Heart failure, Telemonitoring, Determinants of adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TELEmonitoring intervention
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Medication Adherence Support System (MASS)
Other Intervention Name(s)
PICO® by Vitaphone Nederland BV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in medication adherence
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Title
Change in number of hospitalizations (costs)
Description
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.
Time Frame
Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary Outcome Measure Information:
Title
Change in self-care behavior and Quality of Life
Time Frame
Baseline, 6 months, 12 months, and 18 months
Title
Course of disease severity
Description
Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms
Time Frame
Baseline, 6 months, 12 months, and 18 months
Title
Change in psychological variables
Description
Type D personality, depression, anxiety
Time Frame
Baseline, 6 months, 12 months, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Kupper
Organizational Affiliation
Tilburg University, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
TweeSteden Hospital
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5042AD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21999637
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.
Results Reference
derived

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

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