Heart FailurevHFCNCT01342276
Trial of an Internet-based Platform for Monitoring Heart Failure Patients
A study testing vHFC in people with Heart Failure, run by Simon Fraser University at 2 sites in Canada.
Trial summary
Several studies have indicated that heart failure (HF) clinics facilitating patient self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and HF-related hospitalizations, all-cause mortality, and improve patient quality of life. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- vHFC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2011to Nov 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily Internet access
- able to provide informed consent
- able to read, write and understand English without difficulty
Who cannot join
- have significant co-morbidities that may interfere with effective HF management
- reside in a nursing home
- have a disability that precludes walking
- patients in who it is foreseen will be unlikely to survive for the duration of the study or have scheduled surgical procedures that based on the opinion of their hospital attending physician should be excluded
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Hospital of Northern British Columbia
Prince George, British Columbia, V2M 1S2
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance
Several studies have indicated that heart failure (HF) clinics facilitating patient self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and HF-related hospitalizations, all-cause mortality, and improve patient quality of life. Additionally, national and provincial organizations have identified patient-focused homecare initiatives in telehealth as demonstrating great promise for health service. Our pilot study demonstrated the feasibility of the internet based vHFC and supports the investigation of this intervention in patients with HF.
The purpose of our single-blinded randomized trail is to investigate the efficacy of an Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.
Read more
Hypotheses
- Participation in a vHFC emphasizing patient self-management and monitoring will result in improved functional capacity compared to usual care in patients with HF.
- Participation in a vHFC emphasizing patient self-management and monitoring will result in improved health indices such as, self-management skills, quality of life, levels of B-type natriuretic peptide and healthcare utilization compared to usual care in patients with HF.
Our objectives of the vHFC study is as follows:
- To establish a cohort of 186 patients with HF.
- To determine the benefits of participating in the vHFC over usual care at 12 months with respect to exercise capacity.
- To compare the changes in other risk factors and lifestyle behaviours between the vHFC and usual care patients.
Read the detailed description
Consecutive cardiac in-patients of the University Hospital of Northern BC in Prince George and of St. Paul's Hospital in Vancouver will be screened for the Inclusion/Exclusion Criteria. Those who meet the criteria will undergo the baseline assessment.
The baseline assessment will include collecting information on social demographics, (including age, gender, education level, and socioeconomic data) medical history, 6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, and lifestyle (physical activity, smoking status, alcohol consumption). Following baseline assessment, patients will be stratified by sex and randomized to either the vHFC or usual care.
Usual Care Group:
Participants randomized to usual care will be given educational information explaining what HF is, the importance of salt and fluid restriction, a form to log their weight and a list of Internet-based resources.There will be no contact between the study personnel and the usual care participants for the duration of the study, nor will there be any attempt to control for the level of patient care. Participants will return at 12 months for outcome assessment.
Intervention Group:
Upon randomization, a letter will be sent to the participant's primary care provider from the study investigators informing them of their patient's participation in the study with a brief description of the study and a copy of the vHFC Treatment Algorithms to indicate under what circumstances the vHFC nurse and/or participant may contact them with regards to their care. The vHFC nurse (a nurse with experience in chronic disease management) will contact the participants' primary care provider to follow-up on the letter, discuss the intervention protocol and preferred method of communication as well as to provide access to the website to view their participant's progress.
Participants will be given the same educational information as the usual care group and registered to the vHFC website with a unique username and password. Common practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. The investigators have transformed this model to the vHFC such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. Participants can also enter comments for the vHFC nurse in the text box located below the questions. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours (or the next business day in the case of a weekend or holiday). An alert will be logged in the vHFC nurse's 'inbox' of the website and an email will also be sent to the vHFC nurse indicating that a participant alert has been generated. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling. The participant is able to view a graphic depiction of their progress at the same time as the nurse to facilitate the counselling session. At this time a decision regarding what needs to happen will be determined using the Treatment Algorithm. The vHFC nurse will then 'resolve' the alert and document the actions taken in the vHFC.
Study participants from the usual care and vHFC groups will return to the University Hospital of Northern BC or St. Paul's Hospital after 12 months for a full follow-up assessment (6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, lifestyle (physical activity, smoking status, alcohol consumption) and any adverse events)).
- Conditions
- Heart Failure
- Being tested
- vHFC
- Keywords
- Heart failure, Self-management, Telehealth, Internet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vHFCBehavioural
Common practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. We have transformed this model to the vHFC website such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling.
| Study group | Role | What they receive |
|---|---|---|
| vHFC | Experimental | Patients will get to participate in the interactive heart failure website (vHFC). Receives: Behavioral: vHFC |
| Usual Care | No intervention | Patients will not get to participate in the interactive heart failure website (vHFC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Assessed by measuring the distance walked during the 6-minute walk test following the guidelines of the American Thoracic Society.
Measured: 12 months
Secondary outcomes (8)
Self-management skills
Assessed using the Self-Care of Heart Failure Index, which measures a patient's ability to self-manage their condition, and consists of three domains: self-care confidence, maintenance and management.
Measured: 12 months
Quality of life
Assessed using the Minnesota Living with Heart Failure questionnaire.
Measured: 12 months
B-type natriuretic peptide
Measured: 12 months
Health care utilization
Physician visits, lab and diagnostic procedures, hospitalizations and clinical events.
Measured: 12 months
Medication use
Assessed by patient interview.
Measured: 12 months
Blood pressure
Measured: 12 months
Lifestyle
Leisure time physical activity is determined by the 4-week modified Minnesota LTPA questionnaire and smoking status and alcohol intake is assessed by self-report.
Measured: 12 months
Participant adherence to the vHFC
Assessed through website use (logins) and completion of data entry.
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 posted27 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Due to futility of recruitment.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Scott Lear, Simon Fraser University
- Investigators
- Scott A Lear, PhD, Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342276
- Sponsor's protocol ID
- 711207
- Acronym
- vHFC
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2011
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance
- ClinicalTrials.gov ID
- NCT01342276
- Acronym / sponsor ID
- vHFC / 711207
- Conditions
- Heart Failure
- Keywords
- Heart failure, Self-management, Telehealth, Internet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to futility of recruitment.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Apr 2011 (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.
Several studies have indicated that heart failure (HF) clinics facilitating patient self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and HF-related hospitalizations, all-cause mortality, and improve patient quality of life. Additionally, national and provincial organizations have identified patient-focused homecare initiatives in telehealth as demonstrating great promise for health service. Our pilot study demonstrated the feasibility of the internet based vHFC and supports the investigation of this intervention in patients with HF.
The purpose of our single-blinded randomized trail is to investigate the efficacy of an Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.
Hypotheses
- Participation in a vHFC emphasizing patient self-management and monitoring will result in improved functional capacity compared to usual care in patients with HF.
- Participation in a vHFC emphasizing patient self-management and monitoring will result in improved health indices such as, self-management skills, quality of life, levels of B-type natriuretic peptide and healthcare utilization compared to usual care in patients with HF.
Our objectives of the vHFC study is as follows:
- To establish a cohort of 186 patients with HF.
- To determine the benefits of participating in the vHFC over usual care at 12 months with respect to exercise capacity.
- To compare the changes in other risk factors and lifestyle behaviours between the vHFC and usual care patients.
Detailed description
Consecutive cardiac in-patients of the University Hospital of Northern BC in Prince George and of St. Paul's Hospital in Vancouver will be screened for the Inclusion/Exclusion Criteria. Those who meet the criteria will undergo the baseline assessment.
The baseline assessment will include collecting information on social demographics, (including age, gender, education level, and socioeconomic data) medical history, 6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, and lifestyle (physical activity, smoking status, alcohol consumption). Following baseline assessment, patients will be stratified by sex and randomized to either the vHFC or usual care.
Usual Care Group:
Participants randomized to usual care will be given educational information explaining what HF is, the importance of salt and fluid restriction, a form to log their weight and a list of Internet-based resources.There will be no contact between the study personnel and the usual care participants for the duration of the study, nor will there be any attempt to control for the level of patient care. Participants will return at 12 months for outcome assessment.
Intervention Group:
Upon randomization, a letter will be sent to the participant's primary care provider from the study investigators informing them of their patient's participation in the study with a brief description of the study and a copy of the vHFC Treatment Algorithms to indicate under what circumstances the vHFC nurse and/or participant may contact them with regards to their care. The vHFC nurse (a nurse with experience in chronic disease management) will contact the participants' primary care provider to follow-up on the letter, discuss the intervention protocol and preferred method of communication as well as to provide access to the website to view their participant's progress.
Participants will be given the same educational information as the usual care group and registered to the vHFC website with a unique username and password. Common practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. The investigators have transformed this model to the vHFC such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. Participants can also enter comments for the vHFC nurse in the text box located below the questions. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours (or the next business day in the case of a weekend or holiday). An alert will be logged in the vHFC nurse's 'inbox' of the website and an email will also be sent to the vHFC nurse indicating that a participant alert has been generated. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling. The participant is able to view a graphic depiction of their progress at the same time as the nurse to facilitate the counselling session. At this time a decision regarding what needs to happen will be determined using the Treatment Algorithm. The vHFC nurse will then 'resolve' the alert and document the actions taken in the vHFC.
Study participants from the usual care and vHFC groups will return to the University Hospital of Northern BC or St. Paul's Hospital after 12 months for a full follow-up assessment (6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, lifestyle (physical activity, smoking status, alcohol consumption) and any adverse events)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vHFC | Experimental | Behavioral: vHFCPatients will get to participate in the interactive heart failure website (vHFC). |
| Usual Care | No intervention | –Patients will not get to participate in the interactive heart failure website (vHFC). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- daily Internet access
- able to provide informed consent
- able to read, write and understand English without difficulty
Key exclusion criteria (4 listed)
- have significant co-morbidities that may interfere with effective HF management
- reside in a nursing home
- have a disability that precludes walking
- patients in who it is foreseen will be unlikely to survive for the duration of the study or have scheduled surgical procedures that based on the opinion of their hospital attending physician should be excluded
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 |
|---|---|---|
| vHFCCommon practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. We have transformed this model to the vHFC website such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling. | Behavioural | vHFC |
Primary outcome
Functional capacity
Time frame: 12 months
Assessed by measuring the distance walked during the 6-minute walk test following the guidelines of the American Thoracic Society.
8 secondary outcomes
Self-management skills
Time frame: 12 months
Quality of life
Time frame: 12 months
B-type natriuretic peptide
Time frame: 12 months
Health care utilization
Time frame: 12 months
Medication use
Time frame: 12 months
Blood pressure
Time frame: 12 months
Lifestyle
Time frame: 12 months
Participant adherence to the vHFC
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Due to futility of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
Scott A Lear, PhD principal investigator
Simon Fraser University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vHFC in people with Heart Failure, run by Simon Fraser University at 2 sites 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 3 inclusion and 4 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Due to futility of recruitment.). 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?
Functional capacity (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 15 Apr 2016.