Heart Failure, CongestiveTEHAF2NCT00502255
Telemonitoring in Patients With Heart Failure
A study testing Health Buddy system and Telemonitoring in patients with heart failure in people with Heart Failure, Congestive, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Health Buddy system and Telemonitoring in patients with heart failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2007to Dec 2013
- 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
- Patients > 18 years
- Patients with heart failure NYHA classification II-III-IV
- Patient experienced a period of fluid retention
- Patient is treated by a cardiologist
- Patient is followed-up by a heart failure nurse
- Adequate knowledge of the Dutch language
Show all 9Show fewer
- Patient has an active telephone connection, preferably analogue
- Patient is mental competent
- Patient has the disposal of a balance
Who cannot join
- Patients suffering from COPD, Gold classification 3 or 4
- Patient is a dialysis patient
- Patient has a visual restriction to read the dialogues on the Health Buddy
- Patient is hard of hearing or deaf
- Patient suffers from a lethal sickness with a prognosis < 1 year
- Patient participates in another trial
Show all 9Show fewer
- Patient needs a hospital admission on short time, i.e., < 3 months
- Patient used the Health Buddy in an earlier stage
- Patient is an illiterate person.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Atrium Medische Centrum
Heerlen, Limburg
Maastricht University Hospital
Maastricht, Limburg, 6202 AZ
Orbis Medische en Zorgconcern
Sittard, Limburg
About this study
The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
- Conditions
- Heart Failure, Congestive
- Being tested
- Health Buddy system, Telemonitoring in patients with heart failure
- Keywords
- Telemonitoring, Cost-effectiveness, Heart failure, Case management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Buddy systemDevice
Also called TEHAF study, Therapy compliance in patients with heart failure, Cost effectiveness
Patients are followed on distance by the Health Buddy system.
Telemonitoring in patients with heart failureDevice
Also called TEHAf study
Health Buddy in patients home situation.
| Study group | Role | What they receive |
|---|---|---|
| telemonitoring | Experimental | Health Buddy in patients home situation Receives: Device: Health Buddy system |
| usual care | Experimental | patients receive care as usual Receives: Device: Telemonitoring in patients with heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To what extent does the use of Health Buddy result in a decrease in hospital admissions?
Measured: one year
To what extent is Health Buddy® more cost-effective than usual care?
Measured: one year
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
Measured: one year
Secondary outcomes (2)
What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life?
Measured: one year
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Josiane Boyne, Maastricht University Medical Center
- Investigators
- Hubertus J Vrijhoef, Dr, Study chair, University Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502255
- Sponsor's protocol ID
- 072036
- Acronym
- TEHAF2
- Status last verified
- Apr 2015
- First submitted
- 16 Jul 2007
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boyne JJ, Vrijhoef HJ, Crijns HJ, De Weerd G, Kragten J, Gorgels AP; TEHAF investigators. Tailored telemonitoring in patients with heart failure: results of a multicentre randomized controlled trial. Eur J Heart Fail. 2012 Jul;14(7):791-801. doi: 10.1093/eurjhf/hfs058. Epub 2012 May 15.
PubMed 22588319Boyne JJ, Vrijhoef HJ, Wit Rd, Gorgels AP. Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Int J Nurs Stud. 2011 Jan;48(1):94-9. doi: 10.1016/j.ijnurstu.2010.05.017. Epub 2010 Jul 7.
PubMed 20615505
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00502255
- Acronym / sponsor ID
- TEHAF2 / 072036
- Conditions
- Heart Failure, Congestive
- Keywords
- Telemonitoring, Cost-effectiveness, Heart failure, Case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Oct 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jul 2007 (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 purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemonitoring | Experimental | Device: Health Buddy systemHealth Buddy in patients home situation |
| usual care | Experimental | Device: Telemonitoring in patients with heart failurepatients receive care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients > 18 years
- Patients with heart failure NYHA classification II-III-IV
- Patient experienced a period of fluid retention
- Patient is treated by a cardiologist
- Patient is followed-up by a heart failure nurse
Key exclusion criteria (9 listed)
- Patients suffering from COPD, Gold classification 3 or 4
- Patient is a dialysis patient
- Patient has a visual restriction to read the dialogues on the Health Buddy
- Patient is hard of hearing or deaf
- Patient suffers from a lethal sickness with a prognosis < 1 year
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 |
|---|---|---|
| Health Buddy systemAlso: TEHAF study, Therapy compliance in patients with heart failure, Cost effectivenessPatients are followed on distance by the Health Buddy system. | Device | telemonitoring |
| Telemonitoring in patients with heart failureAlso: TEHAf studyHealth Buddy in patients home situation. | Device | usual care |
Primary outcome
To what extent does the use of Health Buddy result in a decrease in hospital admissions?
Time frame: one year
To what extent is Health Buddy® more cost-effective than usual care?
Time frame: one year
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
Time frame: one year
2 secondary outcomes
What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life?
Time frame: one year
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
Time frame: one year
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 8 Apr 2015.
- Derived from this study: PubMed 22588319Boyne JJ, Vrijhoef HJ, Crijns HJ, De Weerd G, Kragten J, Gorgels AP; TEHAF investigators. Tailored telemonitoring in patients with heart failure: results of a multicentre randomized controlled trial. Eur J Heart Fail. 2012 Jul;14(7):791-801. doi: 10.1093/eurjhf/hfs058. Epub 2012 May 15.
- Derived from this study: PubMed 20615505Boyne JJ, Vrijhoef HJ, Wit Rd, Gorgels AP. Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Int J Nurs Stud. 2011 Jan;48(1):94-9. doi: 10.1016/j.ijnurstu.2010.05.017. Epub 2010 Jul 7.
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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.
Hubertus J Vrijhoef, Dr study chair
University Maastricht
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Buddy system and Telemonitoring in patients with heart failure in people with Heart Failure, Congestive, run by Maastricht University Medical Center at 3 sites 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 9 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 8 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 3 sites 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 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?
To what extent does the use of Health Buddy result in a decrease in hospital admissions? (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT00502255, which also lists 2 linked publications.
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 8 Apr 2015.