Heart FailureNCT00778986
Effects of Remote Patient Monitoring on Heart Failure Management
A study testing heart failure remote patient monitoring system in people with Heart Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- heart failure remote patient monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Sep 2010
- 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
- Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- Out-patients attending the University Health Network Heart Failure Clinic
- English-speaking and able to read English
- 18 years old or over
Who cannot join
- Awaiting heart transplantation
- Not expected to survive over a year (as determined by their cardiologist)
- Unable to read text on a mobile phone due to vision disability
- Unable to self-care due to anxiety, depression, or decreased cognitive function
- Lack of manual dexterity to accurately press buttons on the mobile phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.
Read the detailed description
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
- Conditions
- Heart Failure
- Being tested
- heart failure remote patient monitoring system
- Keywords
- heart failure, remote patient monitoring, telemonitoring, home monitoring, randomized controlled trial, self care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart failure remote patient monitoring systemDevice
remote monitoring of weight, blood pressure, ECG, and symptoms
| Study group | Role | What they receive |
|---|---|---|
| remote monitoring | Experimental | group of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic Receives: Device: heart failure remote patient monitoring system |
| control | No intervention | group of patients provided with usual care at the University Health Network Heart Failure Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Natriuretic Peptide values
Measured: Baseline, 6 months
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Measured: baseline, 6 months
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Measured: baseline, 6 months
Secondary outcomes (4)
Number of hospitalizations and days in hospital
Measured: 6 months comparison between intervention and control groups
Number of Emergency Department visits
Measured: 6 month comparison between intervention and control groups
All cause mortality
Measured: 6 month comparison between intervention and control groups
Number of Heart Failure Clinic visits
Measured: 6 month comparison between intervention and control groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startMar 2009
- Primary completionSep 2010
- Study completionSep 2010
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 FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Heather J Ross, MD, MHSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778986
- Sponsor's protocol ID
- HF-RPM-UHN
- Status last verified
- Sep 2010
- First submitted
- 23 Oct 2008
- Last updated
- 30 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
PubMed 22465288Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
PubMed 22356799
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00778986
- Acronym / sponsor ID
- HF-RPM-UHN
- Conditions
- Heart Failure
- Keywords
- heart failure, remote patient monitoring, telemonitoring, home monitoring, randomized controlled trial, self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Oct 2008 (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 randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.
Detailed description
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote monitoring | Experimental | Device: heart failure remote patient monitoring systemgroup of patients that will be using the heart failure remote patient monitoring system in addition to the usual care they receive at the University Health Network Heart Failure Clinic |
| control | No intervention | –group of patients provided with usual care at the University Health Network Heart Failure Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- Out-patients attending the University Health Network Heart Failure Clinic
- English-speaking and able to read English
- 18 years old or over
Key exclusion criteria (5 listed)
- Awaiting heart transplantation
- Not expected to survive over a year (as determined by their cardiologist)
- Unable to read text on a mobile phone due to vision disability
- Unable to self-care due to anxiety, depression, or decreased cognitive function
- Lack of manual dexterity to accurately press buttons on the mobile phone
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 |
|---|---|---|
| heart failure remote patient monitoring systemremote monitoring of weight, blood pressure, ECG, and symptoms | Device | remote monitoring |
Primary outcome
Brain Natriuretic Peptide values
Time frame: Baseline, 6 months
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
Time frame: baseline, 6 months
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
Time frame: baseline, 6 months
4 secondary outcomes
Number of hospitalizations and days in hospital
Time frame: 6 months comparison between intervention and control groups
Number of Emergency Department visits
Time frame: 6 month comparison between intervention and control groups
All cause mortality
Time frame: 6 month comparison between intervention and control groups
Number of Heart Failure Clinic visits
Time frame: 6 month comparison between intervention and control groups
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 30 Sep 2010.
- Derived from this study: PubMed 22465288Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556-65. doi: 10.1016/j.ijmedinf.2012.03.001. Epub 2012 Mar 31.
- Derived from this study: PubMed 22356799Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
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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.
Heather J Ross, MD, MHSc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart failure remote patient monitoring system in people with Heart Failure, run by University Health Network, Toronto at 1 site in Canada.
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 5 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 30 Sep 2010. 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 Canada. 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?
Brain Natriuretic Peptide values (time frame: Baseline, 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?
On the ClinicalTrials.gov record for NCT00778986, 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 30 Sep 2010.