Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
61 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-25
Study Completion Date
2023-01-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
INTRODUCTION
Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes.
HYPOTHESES
At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion.
RECRUITMENT
HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months.
DESIGN
ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments.
ANALYSIS
Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p \< 0.05, 2-sided.
Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes.
HYPOTHESES
At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion.
RECRUITMENT
HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months.
DESIGN
ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments.
ANALYSIS
Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p \< 0.05, 2-sided.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
BACKGROUND
HF is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood to meet the body's metabolic demands during exercise or at rest. At 55 years, the lifetime risk for HF is 29% for women and 33% for men. HF is a major cause of psychological distress and reduced quality of life. The 1-year rehospitalization rate is 40%. The 5-year mortality rate is 45% and 60% for women and men, respectively.
The incidence of cardiovascular mortality decreases with incremental adherence to self-care. Improvement in HF self-care also predicts greater quality of life at 12 months. However, in the absence of intervention, only 9-36% of HF patients have moderate to high adherence to these behaviours. Barriers to self-care include poor health literacy and social isolation, which are present in 39% and 25% of HF patients, respectively. These barriers are associated with depressed mood and low motivation, both of which increase the risk for poor clinical outcomes.
Home-based telehealth programs such as the present ODYSSEE-vCHAT digital initiative are changing practice standards for outpatient medical care. A telehealth program of social network support that is integrated with automated digital counselling is central to this proposal. This approach has demonstrated potential to improve overall wellbeing and sustain positive behavioural changes through information sharing, structured presentations, and role modelling.
RATIONALE
Task force statements advocate for digital interventions that are patient-centred, scalable, and can improve clinical outcomes while reducing healthcare costs. Furthermore, the development of home-based telehealth programs such as ODYSSEE-vCHAT is consistent with guidelines for COVID-19 prevention. Furthermore, integrating a social network intervention with an automated (scalable), evidence-based digital program for HF self-care is likely to optimize therapeutic benefits. A digital social network initiative is central to this trial because of its potential to (i) sustain patient engagement with HF self-care resources, (ii) promote self-care learning and positive role modelling through information sharing and structured presentations, and (iii) improve quality of life and health literacy while reducing perceived social isolation.
HYPOTHESES
The primary hypothesis is that ODYSSEE-vCHAT versus eUC will reduce the risk for a composite index of incident all-cause mortality, all-cause emergency department (ED) visits, and HF-related hospitalization (based on linkage to health administrative a data base) at trial completion (median = 8.5 months, range = 2 to 15 months).
The secondary hypothesis is that engagement with HF self-care resources \[defined by (i) sum logon minutes, (ii) sum logons, and (iii) number of logon days prior to a logon lapse ≥ 2 months\] at months 4, 8, and 12 and trial completion (range = 2 to 15 months) will be independently associated with the following outcomes:
* Health-related quality of life
* Adherence to HF self-care
* Engagement in activities for living well
* Overall mental health
* Health literacy
* Active involvement in medical care
* Perceived social support
* Depression
* Anxiety
* Loneliness
* Use of alcohol, cigarettes, and cannabis
POTENTIAL RISKS
Participants may have experienced discomfort with the following:
* Responding to items in the assessments that are considered personal
* Using ODYSSEE-vCHAT because they are not familiar with the software
* Verbally contributing to the discussion segments of the webcasts as their voice would be recorded
* Submitting an audio or video response to the webcasts because they would no longer be an anonymous participant (audio or video comments may also be used for research and educational purposes in the public domain)
SAFETY PARAMETERS
Refusals to respond to any item(s) posed in the questionnaire packages were accommodated.
Video tutorials on how to use ODYSSEE-vCHAT were provided. Assistance over the telephone was offered when required.
During webcasts, visual input from patients remained disabled to protect their identification. If participants preferred to contribute to the discussion without speaking, they were encouraged to use the chat feature on Zoom instead. Comments written in the chat were not included in the recording of the session.
Participants' audio or video comments were censored for inappropriate comments pertaining to violence, sexual content, coarse language, etc. In regards to videos that were selected for presentation to other participants in the trial, or to the public, patients were notified so that they have an opportunity to grant or withhold their permission for this use of their video.
Social network chatrooms are HIPPA compliant and moderated by three levels of content filtering to ensure that posts meet conventional standards of ethical conduct. Level 1 was a search algorithm that is automatically updated with banned word lists. Level 2 was carried by patient volunteers through self-report. Level 3 is performed by research assistants.
Finally, subjects in the intervention arm were offered an opportunity to send the unblinded research coordinator photographs via email which depict heart-healthy lifestyles. Patients were asked not to include any identifying, sensitive, or personal information (e.g., faces, family members, personal health information, etc.) in the photographs, which would be shared with other participants to encourage social interaction. Participants were informed that they could contact the research team at any time to have their photo submissions withdrawn.
STATISTICAL PLAN
Primary outcome:
At trial completion (median = 8.5 months, range = 2 to 15 months), a time-to-event analysis will be conducted using a multivariable Cox Proportional Hazards model to evaluate if ODYSSEE-vCHAT versus eUC reduced the composite endpoint. Potential confounders will be selected using forward (p \< 0.05) and backward (p \< 0.10) stepwise selection.
Secondary outcomes:
GLMs will evaluate if ODYSSEE-vCHAT versus eUC evokes greater program adherence at months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months), adjusting for potential baseline confounders. The GLM will be repeated using sum logons as the dependent variable. A multivariable Poisson model will evaluate whether ODYSSEE-vCHAT versus eUC is associated with greater duration of engagement, adjusting for potential confounding variables. Separate GLMs will evaluate if ODYSSEE-vCHAT versus eUC improves self-reported outcomes at months 4, 8, and 12 and trial completion, adjusting for endpoints at baseline and potential baseline covariates. Clinical interpretation for health-related quality of life will be based on a group difference of greater than or equal to 5 points. Bonferroni post-hoc tests will be used to assess interactions for relevant groups. Significance in all tests will be p \< 0.05, 2-sided.
Exploratory outcomes:
Separate analyses will be conducted for gender. The Cox Proportional Hazards Model or competing risk models will be used for HF-specific endpoints of mortality, hospitalization, and ED visits, separately and collectively.
DEVIATIONS FROM STATISTICAL PLAN
A need to deviate from the statistical plan was not expected as it involves exploratory analyses. Nevertheless, the Statistical Analysis and Methodology Committee was consulted regularly throughout the trial. Any unplanned analyses will be adjusted using the Bonferroni procedure.
SAMPLE SIZE
Researchers recently reported a reduction over 12 months in a composite index score of all-cause mortality and hospitalization for telehealth support (50.6%) versus usual care (59.3%), p = 0.01. This yielded a sample estimate of 142. Using a 14.7% adjustment rate (142 × 1.147) for withdrawal or attrition based on values obtained from CHF-CePPORT (6.5% of patients withdrew and 8.2% were lost to follow-up), the final sample size estimate was 162, with a type 1 error of 5% and a power of 80%. However, the accrued sample size was N = 61.
COMPLIANCE
Attendance for assessments was facilitated by telephone and email reminders if a participant fails to complete an assessment within 5 to 7 days of receiving the initial invitation.
WITHDRAWAL
Adverse events such as an unforeseen mental health crisis may have affected a patient's ability to participate in this trial. In cases of patient withdrawal, all data up to this point pertaining to the patient will be used for outcome analyses. The Steering Committee were responsible for reviewing how and whether the subject should be replaced in the trial. The referring cardiologist would have been alerted about the withdrawal.
CRITERIA FOR TRIAL TERMINATION
The ODYSSEE-vCHAT trial would have been terminated prematurely in the event of a recurrent adverse event that was related to our trial procedures or content.
QUALITY CONTROL AND ASSURANCE
The Data Review or Monitoring Committee ensured that the trial met an appropriate standard for data quality control. The Steering Committee adjudicated primary and secondary outcomes, as well as reviewed and advised the team about the trial's progress, protocol compliance, and any adverse incidents.
CONSENT
Cardiologists and their nursing staff in participating outpatient clinics identified patients who met trial criteria and obtained verbal consent to be approached by the research team. Research personnel either approached the potential participant in the clinic or entered electronic patient records to obtain their contact information. Informed consent was obtained in person or virtually.
This trial was advertised to HF patients on patient education websites, on posters in participating outpatient clinics, and through mass emails. Patients who contacted the research team through advertising were sent our Referral Form via email to be completed and returned via email by their physician. The Referral Form screened potential participants based on the inclusion and exclusion criteria. Potential participants who qualified for the trial were then directed through the consenting process virtually.
DATA STORAGE
All data is stored on secure servers within the UHN digital environment and will remain there for at least 10 years after trial completion.
Data will be available from the corresponding author pending approval of research ethics boards of participating institutions and on reasonable request received from qualified researchers trained in human subject confidentiality protocols.
PRIVACY AND CONFIDENTIALITY
Subjects are issued a tracking number when data involving identifying information is transmitted for analysis. Subject anonymity and confidentiality has been preserved. Only aggregate data will be published.
All research personnel have signed an employee confidentiality agreement ensuring that confidential information is not disclosed to any other person or entity. All source documents containing personal identifiers are stored in filing cabinets under lock and key. The database is stored electronically on the firewall-protected server, making it inaccessible externally. Access to the room containing the research file server is restricted to designated persons who are employed by the Behavioural Cardiology Research Unit at the UHN.
Discussion of the trial with persons outside the research team will never reveal personal identifiers of participants. All access to data is denied to persons outside the research team. Data transmission occurs via encrypted storage material over the Internet.
HF is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood to meet the body's metabolic demands during exercise or at rest. At 55 years, the lifetime risk for HF is 29% for women and 33% for men. HF is a major cause of psychological distress and reduced quality of life. The 1-year rehospitalization rate is 40%. The 5-year mortality rate is 45% and 60% for women and men, respectively.
The incidence of cardiovascular mortality decreases with incremental adherence to self-care. Improvement in HF self-care also predicts greater quality of life at 12 months. However, in the absence of intervention, only 9-36% of HF patients have moderate to high adherence to these behaviours. Barriers to self-care include poor health literacy and social isolation, which are present in 39% and 25% of HF patients, respectively. These barriers are associated with depressed mood and low motivation, both of which increase the risk for poor clinical outcomes.
Home-based telehealth programs such as the present ODYSSEE-vCHAT digital initiative are changing practice standards for outpatient medical care. A telehealth program of social network support that is integrated with automated digital counselling is central to this proposal. This approach has demonstrated potential to improve overall wellbeing and sustain positive behavioural changes through information sharing, structured presentations, and role modelling.
RATIONALE
Task force statements advocate for digital interventions that are patient-centred, scalable, and can improve clinical outcomes while reducing healthcare costs. Furthermore, the development of home-based telehealth programs such as ODYSSEE-vCHAT is consistent with guidelines for COVID-19 prevention. Furthermore, integrating a social network intervention with an automated (scalable), evidence-based digital program for HF self-care is likely to optimize therapeutic benefits. A digital social network initiative is central to this trial because of its potential to (i) sustain patient engagement with HF self-care resources, (ii) promote self-care learning and positive role modelling through information sharing and structured presentations, and (iii) improve quality of life and health literacy while reducing perceived social isolation.
HYPOTHESES
The primary hypothesis is that ODYSSEE-vCHAT versus eUC will reduce the risk for a composite index of incident all-cause mortality, all-cause emergency department (ED) visits, and HF-related hospitalization (based on linkage to health administrative a data base) at trial completion (median = 8.5 months, range = 2 to 15 months).
The secondary hypothesis is that engagement with HF self-care resources \[defined by (i) sum logon minutes, (ii) sum logons, and (iii) number of logon days prior to a logon lapse ≥ 2 months\] at months 4, 8, and 12 and trial completion (range = 2 to 15 months) will be independently associated with the following outcomes:
* Health-related quality of life
* Adherence to HF self-care
* Engagement in activities for living well
* Overall mental health
* Health literacy
* Active involvement in medical care
* Perceived social support
* Depression
* Anxiety
* Loneliness
* Use of alcohol, cigarettes, and cannabis
POTENTIAL RISKS
Participants may have experienced discomfort with the following:
* Responding to items in the assessments that are considered personal
* Using ODYSSEE-vCHAT because they are not familiar with the software
* Verbally contributing to the discussion segments of the webcasts as their voice would be recorded
* Submitting an audio or video response to the webcasts because they would no longer be an anonymous participant (audio or video comments may also be used for research and educational purposes in the public domain)
SAFETY PARAMETERS
Refusals to respond to any item(s) posed in the questionnaire packages were accommodated.
Video tutorials on how to use ODYSSEE-vCHAT were provided. Assistance over the telephone was offered when required.
During webcasts, visual input from patients remained disabled to protect their identification. If participants preferred to contribute to the discussion without speaking, they were encouraged to use the chat feature on Zoom instead. Comments written in the chat were not included in the recording of the session.
Participants' audio or video comments were censored for inappropriate comments pertaining to violence, sexual content, coarse language, etc. In regards to videos that were selected for presentation to other participants in the trial, or to the public, patients were notified so that they have an opportunity to grant or withhold their permission for this use of their video.
Social network chatrooms are HIPPA compliant and moderated by three levels of content filtering to ensure that posts meet conventional standards of ethical conduct. Level 1 was a search algorithm that is automatically updated with banned word lists. Level 2 was carried by patient volunteers through self-report. Level 3 is performed by research assistants.
Finally, subjects in the intervention arm were offered an opportunity to send the unblinded research coordinator photographs via email which depict heart-healthy lifestyles. Patients were asked not to include any identifying, sensitive, or personal information (e.g., faces, family members, personal health information, etc.) in the photographs, which would be shared with other participants to encourage social interaction. Participants were informed that they could contact the research team at any time to have their photo submissions withdrawn.
STATISTICAL PLAN
Primary outcome:
At trial completion (median = 8.5 months, range = 2 to 15 months), a time-to-event analysis will be conducted using a multivariable Cox Proportional Hazards model to evaluate if ODYSSEE-vCHAT versus eUC reduced the composite endpoint. Potential confounders will be selected using forward (p \< 0.05) and backward (p \< 0.10) stepwise selection.
Secondary outcomes:
GLMs will evaluate if ODYSSEE-vCHAT versus eUC evokes greater program adherence at months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months), adjusting for potential baseline confounders. The GLM will be repeated using sum logons as the dependent variable. A multivariable Poisson model will evaluate whether ODYSSEE-vCHAT versus eUC is associated with greater duration of engagement, adjusting for potential confounding variables. Separate GLMs will evaluate if ODYSSEE-vCHAT versus eUC improves self-reported outcomes at months 4, 8, and 12 and trial completion, adjusting for endpoints at baseline and potential baseline covariates. Clinical interpretation for health-related quality of life will be based on a group difference of greater than or equal to 5 points. Bonferroni post-hoc tests will be used to assess interactions for relevant groups. Significance in all tests will be p \< 0.05, 2-sided.
Exploratory outcomes:
Separate analyses will be conducted for gender. The Cox Proportional Hazards Model or competing risk models will be used for HF-specific endpoints of mortality, hospitalization, and ED visits, separately and collectively.
DEVIATIONS FROM STATISTICAL PLAN
A need to deviate from the statistical plan was not expected as it involves exploratory analyses. Nevertheless, the Statistical Analysis and Methodology Committee was consulted regularly throughout the trial. Any unplanned analyses will be adjusted using the Bonferroni procedure.
SAMPLE SIZE
Researchers recently reported a reduction over 12 months in a composite index score of all-cause mortality and hospitalization for telehealth support (50.6%) versus usual care (59.3%), p = 0.01. This yielded a sample estimate of 142. Using a 14.7% adjustment rate (142 × 1.147) for withdrawal or attrition based on values obtained from CHF-CePPORT (6.5% of patients withdrew and 8.2% were lost to follow-up), the final sample size estimate was 162, with a type 1 error of 5% and a power of 80%. However, the accrued sample size was N = 61.
COMPLIANCE
Attendance for assessments was facilitated by telephone and email reminders if a participant fails to complete an assessment within 5 to 7 days of receiving the initial invitation.
WITHDRAWAL
Adverse events such as an unforeseen mental health crisis may have affected a patient's ability to participate in this trial. In cases of patient withdrawal, all data up to this point pertaining to the patient will be used for outcome analyses. The Steering Committee were responsible for reviewing how and whether the subject should be replaced in the trial. The referring cardiologist would have been alerted about the withdrawal.
CRITERIA FOR TRIAL TERMINATION
The ODYSSEE-vCHAT trial would have been terminated prematurely in the event of a recurrent adverse event that was related to our trial procedures or content.
QUALITY CONTROL AND ASSURANCE
The Data Review or Monitoring Committee ensured that the trial met an appropriate standard for data quality control. The Steering Committee adjudicated primary and secondary outcomes, as well as reviewed and advised the team about the trial's progress, protocol compliance, and any adverse incidents.
CONSENT
Cardiologists and their nursing staff in participating outpatient clinics identified patients who met trial criteria and obtained verbal consent to be approached by the research team. Research personnel either approached the potential participant in the clinic or entered electronic patient records to obtain their contact information. Informed consent was obtained in person or virtually.
This trial was advertised to HF patients on patient education websites, on posters in participating outpatient clinics, and through mass emails. Patients who contacted the research team through advertising were sent our Referral Form via email to be completed and returned via email by their physician. The Referral Form screened potential participants based on the inclusion and exclusion criteria. Potential participants who qualified for the trial were then directed through the consenting process virtually.
DATA STORAGE
All data is stored on secure servers within the UHN digital environment and will remain there for at least 10 years after trial completion.
Data will be available from the corresponding author pending approval of research ethics boards of participating institutions and on reasonable request received from qualified researchers trained in human subject confidentiality protocols.
PRIVACY AND CONFIDENTIALITY
Subjects are issued a tracking number when data involving identifying information is transmitted for analysis. Subject anonymity and confidentiality has been preserved. Only aggregate data will be published.
All research personnel have signed an employee confidentiality agreement ensuring that confidential information is not disclosed to any other person or entity. All source documents containing personal identifiers are stored in filing cabinets under lock and key. The database is stored electronically on the firewall-protected server, making it inaccessible externally. Access to the room containing the research file server is restricted to designated persons who are employed by the Behavioural Cardiology Research Unit at the UHN.
Discussion of the trial with persons outside the research team will never reveal personal identifiers of participants. All access to data is denied to persons outside the research team. Data transmission occurs via encrypted storage material over the Internet.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Heart Failure
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Digital health
Digital counselling
Self-care
Clinical trial
Clinical outcomes
Cognitive-behavioural therapy
Health-related quality of life
Motivational interviewing
eHealth
Social Networking
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Double arm, parallel group, single-blind randomized trial
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Investigators
An independent statistician logged on to a secure program (managed by the UHN THETA institute) that used randomly permuted blocks to assign subjects to ODYSSEE-vCHAT or the control group. To reduce the chance of patient allocation being predictable, we followed the convention whereby the block sizes and the fraction of each block size were known only by an independent statistician. We tested this algorithm with staff at THETA prior to subject recruitment. Our team of investigators remained blinded to ensure impartiality in decisions about procedures and analyses.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ODYSSEE-vCHAT
ODYSSEE-vCHAT consisted of:
* Automated digital counselling resources (educational pages, videos, tools, and trackers)
* Chatrooms available 24/7
* Weekly 30-minute webcasts led by a healthcare professional or patient representative
Each aspect was informed by a rotating schedule of 7 weekly self-care themes. Webcasts were recorded and streamed to our private YouTube channel, and associated hyperlinks were shared on the program. Subjects had the option of submitting photographs depicting heart-healthy lifestyles and activities (with no identifying, sensitive, or personal information) to the Gallery Wall.
Subjects were invited by email to access the resources available to them. They logged on to the program using password-protected personal accounts. Each participant's total number of logins and login time (with timestamps) were recorded. Assessments occurred online at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).
Group Type
EXPERIMENTAL
ODYSSEE-vCHAT
Intervention Type
BEHAVIORAL
Automated digital counselling program with social network support
eUC
eUC provided educational HF self-care resources that are available to the public on professional heart health websites (e.g., Heart Failure Society of Canada, American Heart Association, European Society of Cardiology, Health Canada). Patients were provided with unlimited access to these resources. Subjects were invited by weekly emails to partake in these resources. Self-reported assessments are administered at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months).
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ODYSSEE-vCHAT
Automated digital counselling program with social network support
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Biological males and females who are at least 18 years old and diagnosed with HF with reduced, mid-range, or preserved ejection fraction corresponding to the New York Heart Association Classes 2 to 4 (NYHA II-IV) for 3 or more months prior to enrollment
* Reduced (less than or equal to 40%), mid-range (41 to 49%), or preserved (equal to or greater than 50%) left ventricular ejection fraction, with documentation by ventriculography or quantitative echocardiography (these data are readily available as per the standard of care)
* No worsening of HF for 1 month prior to recruitment, as determined by a referring physician
* Receiving medical treatment in compliance with the Canadian Cardiovascular Society's guideline-directed therapy for at least 1 month prior to enrollment
* Oral and written comprehension of English
* Personal access to an email address, a computer, and the Internet
* Informed written consent
* Reduced (less than or equal to 40%), mid-range (41 to 49%), or preserved (equal to or greater than 50%) left ventricular ejection fraction, with documentation by ventriculography or quantitative echocardiography (these data are readily available as per the standard of care)
* No worsening of HF for 1 month prior to recruitment, as determined by a referring physician
* Receiving medical treatment in compliance with the Canadian Cardiovascular Society's guideline-directed therapy for at least 1 month prior to enrollment
* Oral and written comprehension of English
* Personal access to an email address, a computer, and the Internet
* Informed written consent
Exclusion Criteria
* Scheduled for advanced surgical therapy (e.g., heart transplantation or implantation of a left ventricular assistive device) within 3 months of enrollment
* Record of significant comorbidities at enrollment that is expected to prohibit full participation (e.g., dementia, psychosis, or severe depression)
* HF secondary to uncorrected valvular cardiomyopathy, predominant right-sided HF, or a non-cardiac disease
* Record of significant comorbidities at enrollment that is expected to prohibit full participation (e.g., dementia, psychosis, or severe depression)
* HF secondary to uncorrected valvular cardiomyopathy, predominant right-sided HF, or a non-cardiac disease
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sunnybrook Health Sciences Centre
OTHER
Sponsor Role
collaborator
Mount Sinai Hospital, Canada
OTHER
Sponsor Role
collaborator
University Health Network, Toronto
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rob P Nolan, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Health Network
Toronto, Ontario, Canada
Site Status
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Site Status
Mount Sinai Hospital
Toronto, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26.
Reference Type
BACKGROUND
Dekker RL. Patient perspectives about depressive symptoms in heart failure: a review of the qualitative literature. J Cardiovasc Nurs. 2014 Jan-Feb;29(1):E9-15. doi: 10.1097/JCN.0b013e318273a5d6.
Reference Type
BACKGROUND
Lee KS, Lennie TA, Wu JR, Biddle MJ, Moser DK. Depressive symptoms, health-related quality of life, and cardiac event-free survival in patients with heart failure: a mediation analysis. Qual Life Res. 2014 Aug;23(6):1869-76. doi: 10.1007/s11136-014-0636-5. Epub 2014 Feb 1.
Reference Type
BACKGROUND
Lee DS, Johansen H, Gong Y, Hall RE, Tu JV, Cox JL; Canadian Cardiovascular Outcomes Research Team. Regional outcomes of heart failure in Canada. Can J Cardiol. 2004 May 1;20(6):599-607.
Reference Type
BACKGROUND
Malcom J, Arnold O, Howlett JG, Ducharme A, Ezekowitz JA, Gardner M, Giannetti N, Haddad H, Heckman GA, Isaac D, Jong P, Liu P, Mann E, McKelvie RS, Moe GW, Svendsen AM, Tsuyuki RT, O'Halloran K, Ross HJ, Sequeira EJ, White M; Canadian Cardiovascular Society. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure--2008 update: best practices for the transition of care of heart failure patients, and the recognition, investigation and treatment of cardiomyopathies. Can J Cardiol. 2008 Jan;24(1):21-40. doi: 10.1016/s0828-282x(08)70545-2.
Reference Type
BACKGROUND
Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.
Reference Type
BACKGROUND
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
Reference Type
BACKGROUND
Bleumink GS, Knetsch AM, Sturkenboom MC, Straus SM, Hofman A, Deckers JW, Witteman JC, Stricker BH. Quantifying the heart failure epidemic: prevalence, incidence rate, lifetime risk and prognosis of heart failure The Rotterdam Study. Eur Heart J. 2004 Sep;25(18):1614-9. doi: 10.1016/j.ehj.2004.06.038.
Reference Type
BACKGROUND
Bramley TJ, Gerbino PP, Nightengale BS, Frech-Tamas F. Relationship of blood pressure control to adherence with antihypertensive monotherapy in 13 managed care organizations. J Manag Care Pharm. 2006 Apr;12(3):239-45. doi: 10.18553/jmcp.2006.12.3.239.
Reference Type
BACKGROUND
Granger BB, Swedberg K, Ekman I, Granger CB, Olofsson B, McMurray JJ, Yusuf S, Michelson EL, Pfeffer MA; CHARM investigators. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHARM programme: double-blind, randomised, controlled clinical trial. Lancet. 2005 Dec 10;366(9502):2005-11. doi: 10.1016/S0140-6736(05)67760-4.
Reference Type
BACKGROUND
Khaw KT, Wareham N, Bingham S, Welch A, Luben R, Day N. Combined impact of health behaviours and mortality in men and women: the EPIC-Norfolk prospective population study. PLoS Med. 2008 Jan 8;5(1):e12. doi: 10.1371/journal.pmed.0050012.
Reference Type
BACKGROUND
Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177.
Reference Type
BACKGROUND
Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki RT, Varney J, Johnson JA. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ. 2006 Jul 1;333(7557):15. doi: 10.1136/bmj.38875.675486.55. Epub 2006 Jun 21.
Reference Type
BACKGROUND
Musekamp G, Schuler M, Seekatz B, Bengel J, Faller H, Meng K. Does improvement in self-management skills predict improvement in quality of life and depressive symptoms? A prospective study in patients with heart failure up to one year after self-management education. BMC Cardiovasc Disord. 2017 Feb 15;17(1):51. doi: 10.1186/s12872-017-0486-5.
Reference Type
BACKGROUND
Evangelista LS, Shinnick MA. What do we know about adherence and self-care? J Cardiovasc Nurs. 2008 May-Jun;23(3):250-7. doi: 10.1097/01.JCN.0000317428.98844.4d.
Reference Type
BACKGROUND
Marti CN, Georgiopoulou VV, Giamouzis G, Cole RT, Deka A, Tang WH, Dunbar SB, Smith AL, Kalogeropoulos AP, Butler J. Patient-reported selective adherence to heart failure self-care recommendations: a prospective cohort study: the Atlanta Cardiomyopathy Consortium. Congest Heart Fail. 2013 Jan-Feb;19(1):16-24. doi: 10.1111/j.1751-7133.2012.00308.x. Epub 2012 Sep 9.
Reference Type
BACKGROUND
Cajita MI, Cajita TR, Han HR. Health Literacy and Heart Failure: A Systematic Review. J Cardiovasc Nurs. 2016 Mar-Apr;31(2):121-30. doi: 10.1097/JCN.0000000000000229.
Reference Type
BACKGROUND
Manemann SM, Chamberlain AM, Roger VL, Griffin JM, Boyd CM, Cudjoe TKM, Jensen D, Weston SA, Fabbri M, Jiang R, Finney Rutten LJ. Perceived Social Isolation and Outcomes in Patients With Heart Failure. J Am Heart Assoc. 2018 May 23;7(11):e008069. doi: 10.1161/JAHA.117.008069.
Reference Type
BACKGROUND
Zou H, Chen Y, Fang W, Zhang Y, Fan X. The mediation effect of health literacy between subjective social status and depressive symptoms in patients with heart failure. J Psychosom Res. 2016 Dec;91:33-39. doi: 10.1016/j.jpsychores.2016.10.006. Epub 2016 Oct 19.
Reference Type
BACKGROUND
Matsuoka S, Kato N, Kayane T, Yamada M, Koizumi M, Ikegame T, Tsuchihashi-Makaya M. Development and Validation of a Heart Failure-Specific Health Literacy Scale. J Cardiovasc Nurs. 2016 Mar-Apr;31(2):131-9. doi: 10.1097/JCN.0000000000000226.
Reference Type
BACKGROUND
Zou H, Chen Y, Fang W, Zhang Y, Fan X. Identification of factors associated with self-care behaviors using the COM-B model in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2017 Aug;16(6):530-538. doi: 10.1177/1474515117695722. Epub 2017 Feb 1.
Reference Type
BACKGROUND
Bauer LK, Caro MA, Beach SR, Mastromauro CA, Lenihan E, Januzzi JL, Huffman JC. Effects of depression and anxiety improvement on adherence to medication and health behaviors in recently hospitalized cardiac patients. Am J Cardiol. 2012 May 1;109(9):1266-71. doi: 10.1016/j.amjcard.2011.12.017. Epub 2012 Feb 9.
Reference Type
BACKGROUND
Tierney S, Mamas M, Woods S, Rutter MK, Gibson M, Neyses L, Deaton C. What strategies are effective for exercise adherence in heart failure? A systematic review of controlled studies. Heart Fail Rev. 2012 Jan;17(1):107-15. doi: 10.1007/s10741-011-9252-4.
Reference Type
BACKGROUND
Moraska AR, Chamberlain AM, Shah ND, Vickers KS, Rummans TA, Dunlay SM, Spertus JA, Weston SA, McNallan SM, Redfield MM, Roger VL. Depression, healthcare utilization, and death in heart failure: a community study. Circ Heart Fail. 2013 May;6(3):387-94. doi: 10.1161/CIRCHEARTFAILURE.112.000118. Epub 2013 Mar 19.
Reference Type
BACKGROUND
Daniel H, Sulmasy LS; Health and Public Policy Committee of the American College of Physicians. Policy recommendations to guide the use of telemedicine in primary care settings: an American College of Physicians position paper. Ann Intern Med. 2015 Nov 17;163(10):787-9. doi: 10.7326/M15-0498. Epub 2015 Sep 8.
Reference Type
BACKGROUND
Cowie MR, Bax J, Bruining N, Cleland JG, Koehler F, Malik M, Pinto F, van der Velde E, Vardas P. e-Health: a position statement of the European Society of Cardiology. Eur Heart J. 2016 Jan 1;37(1):63-6. doi: 10.1093/eurheartj/ehv416. Epub 2015 Aug 24. No abstract available.
Reference Type
BACKGROUND
Eapen ZJ, Turakhia MP, McConnell MV, Graham G, Dunn P, Tiner C, Rich C, Harrington RA, Peterson ED, Wayte P. Defining a Mobile Health Roadmap for Cardiovascular Health and Disease. J Am Heart Assoc. 2016 Jul 12;5(7):e003119. doi: 10.1161/JAHA.115.003119. No abstract available.
Reference Type
BACKGROUND
Bhavnani SP, Parakh K, Atreja A, Druz R, Graham GN, Hayek SS, Krumholz HM, Maddox TM, Majmudar MD, Rumsfeld JS, Shah BR. 2017 Roadmap for Innovation-ACC Health Policy Statement on Healthcare Transformation in the Era of Digital Health, Big Data, and Precision Health: A Report of the American College of Cardiology Task Force on Health Policy Statements and Systems of Care. J Am Coll Cardiol. 2017 Nov 28;70(21):2696-2718. doi: 10.1016/j.jacc.2017.10.018. No abstract available.
Reference Type
BACKGROUND
Stogios N, Kaur B, Huszti E, Vasanthan J, Nolan RP. Advancing Digital Health Interventions as a Clinically Applied Science for Blood Pressure Reduction: A Systematic Review and Meta-analysis. Can J Cardiol. 2020 May;36(5):764-774. doi: 10.1016/j.cjca.2019.11.010. Epub 2019 Nov 15.
Reference Type
BACKGROUND
Wu RC, Delgado D, Costigan J, Ross H, MacIver J. Pilot study of an Internet patient-physician communication tool for heart failure disease management. World Hosp Health Serv. 2006;42(3):32-8.
Reference Type
BACKGROUND
Sakakibara BM, Ross E, Arthur G, Brown-Ganzert L, Petrin S, Sedlak T, Lear SA. Using Mobile-Health to Connect Women with Cardiovascular Disease and Improve Self-Management. Telemed J E Health. 2017 Mar;23(3):233-239. doi: 10.1089/tmj.2016.0133. Epub 2016 Sep 13.
Reference Type
BACKGROUND
van Woudenberg TJ, Simoski B, Fernandes de Mello Araujo E, Bevelander KE, Burk WJ, Smit CR, Buijs L, Klein M, Buijzen M. Identifying Influence Agents That Promote Physical Activity Through the Simulation of Social Network Interventions: Agent-Based Modeling Study. J Med Internet Res. 2019 Aug 5;21(8):e12914. doi: 10.2196/12914.
Reference Type
BACKGROUND
Chung ML, Moser DK, Lennie TA, Frazier SK. Perceived social support predicted quality of life in patients with heart failure, but the effect is mediated by depressive symptoms. Qual Life Res. 2013 Sep;22(7):1555-63. doi: 10.1007/s11136-012-0294-4. Epub 2012 Oct 18.
Reference Type
BACKGROUND
Trinacty M, Farrell B, Schindel TJ, Sunstrum L, Dolovich L, Kennie N, Russell G, Waite N. Learning and networking: utilization of a primary care listserv by pharmacists. Can J Hosp Pharm. 2014 Sep;67(5):343-52. doi: 10.4212/cjhp.v67i5.1388.
Reference Type
BACKGROUND
Seidel RL, Jalilvand A, Kunjummen J, Gilliland L, Duszak R Jr. Radiologists and Social Media: Do Not Forget About Facebook. J Am Coll Radiol. 2018 Jan;15(1 Pt B):224-228. doi: 10.1016/j.jacr.2017.09.013. Epub 2017 Nov 11.
Reference Type
BACKGROUND
Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9.
Reference Type
BACKGROUND
Wu JR, Frazier SK, Rayens MK, Lennie TA, Chung ML, Moser DK. Medication adherence, social support, and event-free survival in patients with heart failure. Health Psychol. 2013 Jun;32(6):637-46. doi: 10.1037/a0028527. Epub 2012 Jul 2.
Reference Type
BACKGROUND
Rodriguez-Artalejo F, Guallar-Castillon P, Herrera MC, Otero CM, Chiva MO, Ochoa CC, Banegas JR, Pascual CR. Social network as a predictor of hospital readmission and mortality among older patients with heart failure. J Card Fail. 2006 Oct;12(8):621-7. doi: 10.1016/j.cardfail.2006.06.471.
Reference Type
BACKGROUND
Bonniface L, Green L. Finding a new kind of knowledge on the HeartNET website. Health Info Libr J. 2007 Dec;24 Suppl 1:67-76. doi: 10.1111/j.1471-1842.2007.00742.x.
Reference Type
BACKGROUND
Lau AY, Dunn A, Mortimer N, Proudfoot J, Andrews A, Liaw ST, Crimmins J, Arguel A, Coiera E. Consumers' online social network topologies and health behaviours. Stud Health Technol Inform. 2013;192:77-81.
Reference Type
BACKGROUND
Gammon D, Strand M, Eng LS, Borosund E, Varsi C, Ruland C. Shifting Practices Toward Recovery-Oriented Care Through an E-Recovery Portal in Community Mental Health Care: A Mixed-Methods Exploratory Study. J Med Internet Res. 2017 May 2;19(5):e145. doi: 10.2196/jmir.7524.
Reference Type
BACKGROUND
Toukhsati SR, Driscoll A, Hare DL. Patient Self-management in Chronic Heart Failure - Establishing Concordance Between Guidelines and Practice. Card Fail Rev. 2015 Oct;1(2):128-131. doi: 10.15420/cfr.2015.1.2.128.
Reference Type
BACKGROUND
Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, Barr SI, Gwadry-Sridhar F, Nigam A, Perreault S, Farkouh M, McDonald M, Goodman J, Thomas S, Zieroth S, Isaac D, Oh P, Rajda M, Chen M, Eysenbach G, Liu S, Zbib A. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2014 Jan 30;3(1):e5. doi: 10.2196/resprot.2957.
Reference Type
BACKGROUND
Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
Reference Type
BACKGROUND
Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
Reference Type
BACKGROUND
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
Reference Type
BACKGROUND
Vaglio J Jr, Conard M, Poston WS, O'Keefe J, Haddock CK, House J, Spertus JA. Testing the performance of the ENRICHD Social Support Instrument in cardiac patients. Health Qual Life Outcomes. 2004 May 13;2:24. doi: 10.1186/1477-7525-2-24.
Reference Type
BACKGROUND
Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7.
Reference Type
BACKGROUND
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Reference Type
BACKGROUND
Wongpakaran N, Wongpakaran T, Pinyopornpanish M, Simcharoen S, Suradom C, Varnado P, Kuntawong P. Development and validation of a 6-item Revised UCLA Loneliness Scale (RULS-6) using Rasch analysis. Br J Health Psychol. 2020 May;25(2):233-256. doi: 10.1111/bjhp.12404. Epub 2020 Jan 30.
Reference Type
BACKGROUND
Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.
Reference Type
BACKGROUND
Krum H, Forbes A, Yallop J, Driscoll A, Croucher J, Chan B, Clark R, Davidson P, Huynh L, Kasper EK, Hunt D, Egan H, Stewart S, Piterman L, Tonkin A. Telephone support to rural and remote patients with heart failure: the Chronic Heart Failure Assessment by Telephone (CHAT) study. Cardiovasc Ther. 2013 Aug;31(4):230-7. doi: 10.1111/1755-5922.12009.
Reference Type
BACKGROUND
Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19.
Reference Type
BACKGROUND
Fezza G, Sansone S, Surikova J, Hustzi E, Ross H and Nolan RP. Patient engagement with an e-Counselling platform is enhanced over 12 months in the CHF-CePPORT trial. Can J Cardiol. 2018;10:148-9.
Reference Type
BACKGROUND
Payne AY, Surikova J, Liu S, Ross H, Mechetiuc T, Nolan RP. Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure. JMIR Hum Factors. 2015 May 8;2(1):e7. doi: 10.2196/humanfactors.4125.
Reference Type
BACKGROUND
Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005 Oct;150(4):707-15. doi: 10.1016/j.ahj.2004.12.010.
Reference Type
BACKGROUND
Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009 Jan;11(1):99-105. doi: 10.1093/eurjhf/hfn007.
Reference Type
BACKGROUND
Peiris RG, Ross H, Chan CT, Poon S, Auguste BL, Rac VE, Farkouh M, McDonald M, Kaczorowski J, Code J, Duero Posada J, Ong S, Kobulnik J, Tomlinson G, Huszti E, Arcand J, Thomas SG, Akbari A, Maunder R, Grover S, Seto E, Simard A, Pope B, Bains M, McIntyre C, Torbay C, Syed F, Nolan RP. Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial. BMJ Open. 2022 Sep 5;12(9):e059635. doi: 10.1136/bmjopen-2021-059635.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PJT173222
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
5117
Identifier Type: OTHER
Identifier Source: secondary_id
21-022-E
Identifier Type: OTHER
Identifier Source: secondary_id
20-5960
Identifier Type: -
Identifier Source: org_study_id