Chronic Heart FailurePhase 2TEMA-HF2NCT01696890
Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.
A Phase 2 study testing integrated follow-up in people with Chronic Heart Failure, run by Jessa Hospital at 7 sites in Belgium.
Trial summary
The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- integrated follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesBelgium
- Study dates
- Oct 2011to Dec 2013
- Phase
- Phase 2
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized for decompensation of systolic heart failure
- LVEF < 40% during hospitalization.
Who cannot join
- reversible forms of acute heart failure (acute ischemia, myocarditis,..)
- heart failure due to severe aortic stenosis
- participation in cardiac rehabilitation after discharge
- previous or actual residency in a nursing home
- creatinine clearance <15 ml/min
- planned dialysis in the next 6 months
Show all 10Show fewer
- planned biventricular pacemaker or cardiac surgery
- life expectancy of less than 1 year due to other diseases
- severe obstructive pulmonary disease (Gold III)
- significant mental or cognitive problems interfering with the daily measurements or intake of medication.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
Middelheim Ziekenhuis
Antwerp
UZ Brussel
Brussels
Ziekenhuis Oost-Limburg
Genk
AZ Maria Middelares
Ghent, 9000
Jessa Hospital
Hasselt, 3500
AZ Groeninge
Kortrijk
Chr.Citadelle
Liège
About this study
Official title: Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure
The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.
Read the detailed description
The incidence of acute decompensated heart failure is increasing. Patients with severe heart failure are rehospitalised for decompensation several times each year, increasing the cost for health care. In these cases of recurrent decompensation, the medical intervention in hospital is often limited to increasing the dosage of diuretics or vasodilators until the patient reaches a compensated state. After discharge, a readmission can be expected within a few months. A multidisciplinary approach by primary physician, heart failure nurse, rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and increase quality of life.
Very recently, our study group showed that an intense collaboration between first line practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months follow-up in patients with chronic heart failure. However, a large randomised multicentre trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III) patients did not find any difference between telemonitoring and usual care (Chaudry et al NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The question therefore remains which factors are responsible for success or failure of the use of telemonitoring. Based on our previous experience, the approach of close monitoring by telemonitoring, with first line intervention by the patient's general practitioner (GP) and supervision by the heart failure clinic, might be the critical success factor.
Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.
- Conditions
- Chronic Heart Failure
- Being tested
- integrated follow-up, standard care
- Keywords
- chronic heart failure, telemonitoring, first line practitioners, integrated approach, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated follow-upDevice
close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.
standard careDevice
no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.
| Study group | Role | What they receive |
|---|---|---|
| integrated care | Active comparator | telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic. Receives: Device: integrated follow-up |
| standard care | Active comparator | telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic Receives: Device: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality
Measured: 6 months
number of rehospitalizations
Measured: 6 months
time investment by HF nurses
Measured: 6 months
Secondary outcomes (2)
quality of life
Measured: 6 months
appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionDec 2013
Why it stopped: lack of inclusions, sudden withdrawal of study coordinator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Dendale, Jessa Hospital
- Investigators
- paul dendale, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696890
- Sponsor's protocol ID
- TEMAHF2
- Acronym
- TEMA-HF2
- Status last verified
- Apr 2015
- First submitted
- 29 Mar 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure
- ClinicalTrials.gov ID
- NCT01696890
- Acronym / sponsor ID
- TEMA-HF2 / TEMAHF2
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, telemonitoring, first line practitioners, integrated approach, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusions, sudden withdrawal of study coordinator
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Oct 2012 (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.
The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.
Detailed description
The incidence of acute decompensated heart failure is increasing. Patients with severe heart failure are rehospitalised for decompensation several times each year, increasing the cost for health care. In these cases of recurrent decompensation, the medical intervention in hospital is often limited to increasing the dosage of diuretics or vasodilators until the patient reaches a compensated state. After discharge, a readmission can be expected within a few months. A multidisciplinary approach by primary physician, heart failure nurse, rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and increase quality of life.
Very recently, our study group showed that an intense collaboration between first line practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months follow-up in patients with chronic heart failure. However, a large randomised multicentre trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III) patients did not find any difference between telemonitoring and usual care (Chaudry et al NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The question therefore remains which factors are responsible for success or failure of the use of telemonitoring. Based on our previous experience, the approach of close monitoring by telemonitoring, with first line intervention by the patient's general practitioner (GP) and supervision by the heart failure clinic, might be the critical success factor.
Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| integrated care | Active comparator | Device: integrated follow-uptelemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic. |
| standard care | Active comparator | Device: standard caretelemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients hospitalized for decompensation of systolic heart failure
- LVEF < 40% during hospitalization.
Key exclusion criteria (10 listed)
- reversible forms of acute heart failure (acute ischemia, myocarditis,..)
- heart failure due to severe aortic stenosis
- participation in cardiac rehabilitation after discharge
- previous or actual residency in a nursing home
- creatinine clearance <15 ml/min
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 |
|---|---|---|
| integrated follow-upclose interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made. | Device | integrated care |
| standard careno interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient. | Device | standard care |
Primary outcome
overall mortality
Time frame: 6 months
number of rehospitalizations
Time frame: 6 months
time investment by HF nurses
Time frame: 6 months
2 secondary outcomes
quality of life
Time frame: 6 months
appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of inclusions, sudden withdrawal of study coordinator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
paul dendale, MD, PhD principal investigator
Jessa Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing integrated follow-up in people with Chronic Heart Failure, run by Jessa Hospital at 7 sites in Belgium.
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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of inclusions, sudden withdrawal of study coordinator). Results are not available in the source record.
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?
overall mortality (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.