Heart FailureTELEMED-HFNCT01347528
Improving MEDication Adherence in Chronic Heart Failure Using a TELEmedicine Device (TELEMED-HF)
A study testing Medication Adherence Support System (MASS) in people with Heart Failure, run by Tilburg University at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medication Adherence Support System (MASS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
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.
- Conditions
- Heart Failure
- Being tested
- Medication Adherence Support System (MASS)
- Keywords
- Medication adherence, Heart failure, Telemonitoring, Determinants of adherence
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Adherence Support System (MASS)Behavioural
Also called PICO® by Vitaphone Nederland BV
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.
| Study group | Role | What they receive |
|---|---|---|
| TELEmonitoring intervention | Experimental | Not described Receives: Behavioral: Medication Adherence Support System (MASS) |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months
Secondary outcomes (3)
Change in self-care behavior and Quality of Life
Measured: Baseline, 6 months, 12 months, and 18 months
Course of disease severity
Clinical characteristics (e.g. NYHA function class determination, LVEF, exercise capacity, blood tests) and self-reported HF symptoms
Measured: Baseline, 6 months, 12 months, and 18 months
Change in psychological variables
Type D personality, depression, anxiety
Measured: Baseline, 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: logistic and financial accounting reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Elisabeth-TweeSteden Hospital
- Responsible party
- Principal investigator, Nina Kupper PhD, Tilburg University
- Investigators
- Nina Kupper, Principal investigator, Tilburg University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347528
- Sponsor's protocol ID
- UVT MP 002
- Acronym
- TELEMED-HF
- Status last verified
- Dec 2015
- First submitted
- 29 Apr 2011
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21999637
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Using a TELEmedicine Solution to Improve MEDication Adherence in Chronic Heart Failure (TELEMED-HF)
- ClinicalTrials.gov ID
- NCT01347528
- Acronym / sponsor ID
- TELEMED-HF / UVT MP 002
- Conditions
- Heart Failure
- Keywords
- Medication adherence, Heart failure, Telemonitoring, Determinants of adherence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistic and financial accounting reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- The Elisabeth-TweeSteden Hospital
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TELEmonitoring intervention | Experimental | Behavioral: Medication Adherence Support System (MASS) |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Adherence Support System (MASS)Also: PICO® by Vitaphone Nederland BVThe 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. | Behavioural | TELEmonitoring intervention |
Primary outcome
Change in medication adherence
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in self-care behavior and Quality of Life
Time frame: Baseline, 6 months, 12 months, and 18 months
Course of disease severity
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in psychological variables
Time frame: Baseline, 6 months, 12 months, and 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 21999637Kessing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Kupper principal investigator
Tilburg University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Adherence Support System (MASS) in people with Heart Failure, run by Tilburg University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence (time frame: Baseline, 6 months, 9 months, 12 months, 15 months, and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.