Telemonitoring in Coronary Artery DiseaseTEMA-HFLTNCT03171038
The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
A study testing Telemonitoring in people with Telemonitoring in Coronary Artery Disease, run by Hasselt University.
Trial summary
TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemonitoring in Coronary Artery Disease
- What is being tested?
- Telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to 1 Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure patients
- Treated for heart failure according to current guidelines
- ≥ 18 years of age
- Able to provide informed consent
Who cannot join
- Reversible forms of acute heart failure (myocarditis)
- Presence of severe aortic stenosis
- Previous residency in a nursing home
- Inclusion in a cardiac rehabilitation program on discharge
- Chronic kidney disease stage ≥ 4
- Planned dialysis in the next six months
Show all 9Show fewer
- Life expectancy < 1 year due to non-heart failure related reasons
- Severe chronic obstructive pulmonary disease, GOLD ≥ III
- Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission
About this study
Official title: Long-term Impact of a 6-months Telemedical Care Program on Mortality, Readmissions and Healthcare Costs in Patients With Chronic Heart Failure The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.
Read the detailed description
The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.
The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.
- Being tested
- Telemonitoring
- Keywords
- Telemonitoring, Chronic Heart Failure, eHealth, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | 6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2). Receives: Other: Telemonitoring |
| Usual care group | No intervention | Usual care from t0 up until the common stopping date (t2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality
Measured: Start of study to long-term follow-up (6.5 years).
Secondary outcomes (6)
days lost due to heart failure readmissions
days lost due to heart failure readmissions
Measured: Start of study to long-term follow-up (6.5 years).
days lost due to all readmissions
days lost due to all readmissions
Measured: Start of study to long-term follow-up (6.5 years).
days lost due to death or heart failure readmissions
days lost due to death or heart failure readmissions
Measured: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for heart failure
percentage of follow-up time spent in hospital for heart failure
Measured: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for all reasons
percentage of follow-up time spent in hospital for all reasons
Measured: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time lost to death or heart failure readmissions
percentage of follow-up time lost to death or heart failure readmissions
Measured: Start of study to long-term follow-up (6.5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Apr 2008
- Primary completion1 Aug 2015
- Study completion1 Aug 2015
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 Telemonitoring in Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171038
- Sponsor's protocol ID
- Jessa Hospital
- Acronym
- TEMA-HFLT
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frederix I, Vanderlinden L, Verboven AS, Welten M, Wouters D, De Keulenaer G, Ector B, Elegeert I, Troisfontaines P, Weytjens C, Mullens W, Dendale P. Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure. J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.
PubMed 29742959
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Impact of a 6-months Telemedical Care Program on Mortality, Readmissions and Healthcare Costs in Patients With Chronic Heart Failure The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT03171038
- Acronym / sponsor ID
- TEMA-HFLT / Jessa Hospital
- Keywords
- Telemonitoring, Chronic Heart Failure, eHealth, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 1 Aug 2015 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.
Detailed description
The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.
The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Other: Telemonitoring6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2). |
| Usual care group | No intervention | –Usual care from t0 up until the common stopping date (t2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic heart failure patients
- Treated for heart failure according to current guidelines
- ≥ 18 years of age
- Able to provide informed consent
Key exclusion criteria (9 listed)
- Reversible forms of acute heart failure (myocarditis)
- Presence of severe aortic stenosis
- Previous residency in a nursing home
- Inclusion in a cardiac rehabilitation program on discharge
- Chronic kidney disease stage ≥ 4
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 |
|---|---|---|
| Telemonitoring | Other | Telemonitoring group |
Primary outcome
All-cause mortality
Time frame: Start of study to long-term follow-up (6.5 years).
All-cause mortality
6 secondary outcomes
days lost due to heart failure readmissions
Time frame: Start of study to long-term follow-up (6.5 years).
days lost due to all readmissions
Time frame: Start of study to long-term follow-up (6.5 years).
days lost due to death or heart failure readmissions
Time frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for heart failure
Time frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for all reasons
Time frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time lost to death or heart failure readmissions
Time frame: Start of study to long-term follow-up (6.5 years).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Derived from this study: PubMed 29742959Frederix I, Vanderlinden L, Verboven AS, Welten M, Wouters D, De Keulenaer G, Ector B, Elegeert I, Troisfontaines P, Weytjens C, Mullens W, Dendale P. Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure. J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Telemonitoring in Coronary Artery Disease, run by Hasselt University.
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 9 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: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause mortality (time frame: Start of study to long-term follow-up (6.5 years).). 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 NCT03171038, 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 1 Jun 2017.