Heart FailureNCT02048748
Congestive Heart Failure Home Telemonitoring
A study testing Weight and blood pressure device and Home telemonitoring device in people with Heart Failure and Blood Pressure, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may provide benefits on health care costs and quality of life. Currently there is limited use of remote monitoring for heart failure in Norway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Blood Pressure, Body Weight
- What is being tested?
- Weight and blood pressure device and Home telemonitoring device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to Jan 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
- the presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association [NYHA] functional class II-IV); and
- ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Congestive Heart Failure Home Telemonitoring : A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may provide benefits on health care costs and quality of life. Currently there is limited use of remote monitoring for heart failure in Norway. The funding streams and the structure of the norwegian health service is different from other countries that have tried remote monitoring and therefore it is important to examine the utility of such services in Norway. The study is a randomised controlled trial that will allow participants in the intervention group to use a wireless weight scale and blood pressure monitor device that will send automatically the measurements electronically and securely to the Heart Failure Outpatient Clinic of the hospital.
Read the detailed description
Providing patients with chronic heart failure (CHF) access to remote monitoring, for example by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations and may provide benefits on health care costs and quality of life. Remote monitoring of patients can reduce pressure on resources, particularly for conditions like chronic heart failure, which exert a large burden on health services. These are conclusions of a Cochrane Systematic Review.
In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital treatment, daily use of medication over years, and loss of quality of life for patients and their family caregivers. Generally there is little knowledge about what is gained for the billions used. In Norway no telemonitoring services are established and hence no investigations have yet been published. Thus it seems that current evidence of effectiveness and quality is insufficient to recommend usage. The structure and funding streams in Norwegian health services are different from other countries and the conventional services that the intervention has been compared to in previous studies, are most likely heterogeneous. It is thus important to investigate Norwegian conditions.
Advanced telemonitoring technology with electronic transfer of physiological data such as blood pressure and weight is currently being used in research and established routine services in several countries in Europe, amongst them the Netherlands, Germany and the United Kingdom.
The proposed project intends to introduce such a strategy as an avenue for exploring promising new services that would not otherwise be available in Norway. The service consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at UNN; and monitor the values by a trained nurse at the Heart polyclinic.
The primary objective of this study is thus to explore whether, as compared to current care from the heart polyclinic, the introduction of home telemonitoring will reduce hospital readmissions and will, in addition, be cost-effective. This is in line with the recent directions of European telemonitoring programmes for patients with chronic heart failure. This result may define if the telemonitoring of heart failure patients is feasible for Norway or not at all.
Identifying successful innovations to be introduced into the Norwegian health care services is a condition for more cost effectiveness and better treatment quality.
- Conditions
- Heart Failure, Blood Pressure, Body Weight
- Being tested
- Weight and blood pressure device, Home telemonitoring device
- Keywords
- Home Care Services, Telemedicine
- Medical subject headings
- Heart Failure, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight and blood pressure deviceDevice
Weight and blood pressure device integrated in a home telemonitoring kit. The weight scale is Withings The Smart Bodyscale. The blood pressure device is MEDISANA iHealth BP3.
Home telemonitoring deviceDevice
An iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Device: Weight and blood pressure device Device: Home telemonitoring device Receives: Device: Weight and blood pressure device; Device: Home telemonitoring device |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHF related hospital readmissions
Measured: 12 months
Secondary outcomes (4)
Length of stay
Length of stay per hospitalisation
Measured: 12 months
Quality of Life MLwHF
Measured: 6 months, 12 months
Challenges and opportunities
Qualitative analysis of conditions for identified best practices resulting from the intervention, and possible to be developed. Interview with patients and health professionals. Thematic analysis of transcribed interviews. Identification of themes related to best practices and challenges.
Measured: 12 months
Additional costs/savings resulting from the service
Additional costs/savings resulting from the service defined as the difference in the costs of medical care during the study, identified through a cost analysis, between the intervention and control arms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015
Why it stopped: The study was ended before any patients were enrolled. Department of Clinical Research, August 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Responsible party
- Sponsor
- Investigators
- Artur Serrano, PHD, Principal investigator, Norwegian Centre for Integrated Care and Telemedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048748
- Sponsor's protocol ID
- UNN-NST-TeleCHF-01
- Status last verified
- Jan 2014
- First submitted
- 30 Oct 2013
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congestive Heart Failure Home Telemonitoring : A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
- ClinicalTrials.gov ID
- NCT02048748
- Acronym / sponsor ID
- UNN-NST-TeleCHF-01
- Conditions
- Heart Failure, Blood Pressure, Body Weight
- Keywords
- Home Care Services, Telemedicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was ended before any patients were enrolled. Department of Clinical Research, August 2020.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Jan 2014 (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.
Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may provide benefits on health care costs and quality of life. Currently there is limited use of remote monitoring for heart failure in Norway. The funding streams and the structure of the norwegian health service is different from other countries that have tried remote monitoring and therefore it is important to examine the utility of such services in Norway. The study is a randomised controlled trial that will allow participants in the intervention group to use a wireless weight scale and blood pressure monitor device that will send automatically the measurements electronically and securely to the Heart Failure Outpatient Clinic of the hospital.
Detailed description
Providing patients with chronic heart failure (CHF) access to remote monitoring, for example by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations and may provide benefits on health care costs and quality of life. Remote monitoring of patients can reduce pressure on resources, particularly for conditions like chronic heart failure, which exert a large burden on health services. These are conclusions of a Cochrane Systematic Review.
In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital treatment, daily use of medication over years, and loss of quality of life for patients and their family caregivers. Generally there is little knowledge about what is gained for the billions used. In Norway no telemonitoring services are established and hence no investigations have yet been published. Thus it seems that current evidence of effectiveness and quality is insufficient to recommend usage. The structure and funding streams in Norwegian health services are different from other countries and the conventional services that the intervention has been compared to in previous studies, are most likely heterogeneous. It is thus important to investigate Norwegian conditions.
Advanced telemonitoring technology with electronic transfer of physiological data such as blood pressure and weight is currently being used in research and established routine services in several countries in Europe, amongst them the Netherlands, Germany and the United Kingdom.
The proposed project intends to introduce such a strategy as an avenue for exploring promising new services that would not otherwise be available in Norway. The service consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at UNN; and monitor the values by a trained nurse at the Heart polyclinic.
The primary objective of this study is thus to explore whether, as compared to current care from the heart polyclinic, the introduction of home telemonitoring will reduce hospital readmissions and will, in addition, be cost-effective. This is in line with the recent directions of European telemonitoring programmes for patients with chronic heart failure. This result may define if the telemonitoring of heart failure patients is feasible for Norway or not at all.
Identifying successful innovations to be introduced into the Norwegian health care services is a condition for more cost effectiveness and better treatment quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: Weight and blood pressure device, Device: Home telemonitoring deviceDevice: Weight and blood pressure device Device: Home telemonitoring device |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association [NYHA] functional class II-IV); and
- ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Weight and blood pressure deviceWeight and blood pressure device integrated in a home telemonitoring kit. The weight scale is Withings The Smart Bodyscale. The blood pressure device is MEDISANA iHealth BP3. | Device | Telemonitoring |
| Home telemonitoring deviceAn iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit. | Device | Telemonitoring |
Primary outcome
CHF related hospital readmissions
Time frame: 12 months
4 secondary outcomes
Length of stay
Time frame: 12 months
Quality of Life MLwHF
Time frame: 6 months, 12 months
Challenges and opportunities
Time frame: 12 months
Additional costs/savings resulting from the service
Time frame: 12 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 22 Jun 2021.
- Norwegian Centre for Integrated Care and TelemedicineLink provided by the sponsor.
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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.
Artur Serrano, PHD principal investigator
Norwegian Centre for Integrated Care and Telemedicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight and blood pressure device and Home telemonitoring device in people with Heart Failure and Blood Pressure, run by University Hospital of North Norway at 1 site in Norway.
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 1 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 22 Jun 2021. 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 Norway. 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?
CHF related hospital readmissions (time frame: 12 months). 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 22 Jun 2021.