Coronary Heart DiseaseVCRP-RCTNCT03696446
E-health Intervention for Cardiac Rehabilitation
A study testing Virtual Cardiac Rehabilitation Program and Case Managed Home Program in people with Coronary Heart Disease and Valve Disease, Heart, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure \& cholesterol) in order to improve quality of life and health among people with heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Valve Disease, Heart
- What is being tested?
- Virtual Cardiac Rehabilitation Program and Case Managed Home Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2018to 23 Aug 2022
- 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
- Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);
- Patient has stable Coronary Heart Disease (CHD) or valvular disease;
- Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;
- Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
- Patient is ≥ 18 years of age (the age of consent in Ontario);
- Patient is able to read and understand English or French (programs are available in both languages);
- Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);
Who cannot join
- Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
- Patient, in the opinion of the medical advisor (Dr. Andrew Pipe), manifests illness that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility
Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure \& cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website \& Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.
- Conditions
- Coronary Heart Disease, Valve Disease, Heart
- Being tested
- Virtual Cardiac Rehabilitation Program, Case Managed Home Program
- Keywords
- Cardiac Rehabilitation, Patient Activation
- Medical subject headings
- Coronary Disease, Heart Valve Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Cardiac Rehabilitation ProgramBehavioural
Also called Web-based CR
This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.
Case Managed Home ProgramBehavioural
Also called Phone based CR
This group will receive their Rehab program over the phone with a trained facilitator
| Study group | Role | What they receive |
|---|---|---|
| Virtual Cardiac Rehabilitation Program | Experimental | This group will receive access to the NWC (NexJ Connected Wellness TM (NCW) and will be provided with a fitness tracker (Garmin Vivofit 3) to monitor their exercise, sedentary behaviours, and sleep patterns. The NWC platform includes components for education (health library, workbooks etc), collaboration (personal care plan, appointment scheduler, secure messaging system etc), and motivation (motivational messages on their homepage etc). With the Health Coach, participants will engage in: reviews of their risk factor profile and health priorities; goal setting and action planning; problem solving and skill building; and discussions of relapse prevention. Participants will receive a total of seven hours of health coaching delivered across nine sessions over a 26-week period Receives: Behavioral: Virtual Cardiac Rehabilitation Program |
| Case Managed Home Program | Other | The Case Managed Home Program (CMHP) is delivered primarily via telephone. Following their CR intake, patients are linked with their CMHP Health Coach and attends their visit (in person or over the phone) which includes a comprehensive review of their health history, current symptoms, medications, activity, and individual concerns. Following this visit, participants will receive a total of 10 individualized telephone calls over a 26 week period. The program action plan is individually formulated based on the participant's goals and learning needs. Participants are provided with educational kits (exercise, nutrition, stress management or prevention) that are based on the principle of single point learning and incorporate behavioural change techniques. Receives: Behavioral: Case Managed Home Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
Patient activation will be measured by the Patient Activation Measure (PAM) questionnaire.This 10-item tool assesses the degree to which a patient is engaged or disengaged with their health and how likely they are to self-manage it.The total score of the tool classifies a participant into one of 4 categories; disengaged and overwhelmed (level 1), becoming aware but still struggling (level 2), taking action (level 3) and maintaining behaviors and pushing further (level 4). Higher levels mean participants are becoming better at, or have fully begun to self-manage their health behaviors.
Measured: Baseline - 22 weeks
Secondary outcomes (17)
Tobacco smoking
Participants will be asked 2 questions about tobacco smoking. The first asks about tobacco smoking in the last 6 months. The second asks about tobacco smoking in the last 7 days. If the participant has recently quit smoking we will ask for their quit date. This intervention is not providing smoking cessation counseling however, we are interested in participants cessation attempt as a health behavior change.
Measured: Baseline - 22 weeks
Physical activity
Physical activity will be measured by pedometer. Participants will wear the pedometer for 7 days at baseline and again at 22 week follow up.
Measured: Baseline - 22 weeks
Dietary behaviors
Dietary behaviors will be measured by the Starting the Conversation questionnaire. The questionnaire consists of 8 questions asking about frequency of fast food/snack consumption, fruit, vegetable, fat consumption, snacking and sodium intake. The participant's total score at baseline (sum of all answers, answers ranging from 0-2) will be compared to their total score at week 22. A change is considered a reduction in this score (0-16) between the two study time points. Higher values equate to a diet that could require a change in eating habits (reduction of salty foods or snacks, increase in vegetables/fruits).
Measured: Baseline - 22 weeks
Medication adherence
Medication adherence will be assessed using the Medication Adherence Rating Scale (MARS). This is a 10 item questionnaire that generates a total score out of 10. The higher the score, the greater the adherence.
Measured: Baseline - 22 weeks
Blood pressure
Blood pressure will be measured and recorded in millimeters of mercury. A high measured will be considered 140/90 or higher.
Measured: Baseline - 22 weeks
Low density lipoprotein cholesterol (LDL-C)
LDL-C will be measured and reported in millimoles per litre (mmol/L). Measures < 3.5 mmol/L are considered desirable.
Measured: Baseline - 22 weeks
High density lipoprotein cholesterol (HDL-C)
HDL-C will be measured and reported in millimoles per litre (mmol/L). Measures above 1.3 mmol/L are considered desirable.
Measured: Baseline - 22 weeks
Total cholesterol (TC)
TC will be measured and reported in millimoles per litre (mmol/L). Measures less than 5.2 mmol/L are considered desirable.
Measured: Baseline - 22 weeks
Triglycerides
Triglycerides will be measured and reported in millimoles per litre (mmol/L). Measures less than 5.2 mmol/L are considered desirable. Measures less than 1.7 mmol/L are considered desirable.
Measured: Baseline - 22 weeks
Glycated hemoglobin (A1C)
Fasting A1C will be measured and reported in millimoles per litre (mmol/L). Measures between 4.0 to 7.0 mmol/L are considered desirable.
Measured: Baseline - 22 weeks
Waist circumference
Waist circumference will be collected (measured in cm). A measurement of 88cm or more in women is considered high and is associated with health problems such as risk of developing type 2 diabetes, heart disease and high blood pressure.
Measured: Baseline - 22 weeks
Generic Quality of Life
Generic health-related quality of life will be collected by the Short form Health Survey (SF-36, V1). This is a 36-item questionnaire assessing eight health concepts (physical functioning; role limitations because of physical health problems; bodily pain; social functioning; general mental health (psychological distress and psychological wellbeing); role limitations because of emotional problems; vitality (energy/fatigue); and general health perceptions). Questions are scored on a Likert scale which are then summed to a total between 0-100. Scores are then matched against norm tables.
to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale
Measured: Baseline - 22 weeks
Health Related Quality of Life
Disease specific quality of life will be measured using the Health-related quality of life questionnaire (HeartQoL). This is a 14 item questionnaire developed for use in patients with cardiac disease. There are 10 items related to physical health and 4 related to emotional health. Sub-scales are scored from 0 (poor quality of life) to 3 (better quality of life). Questions are summed to produce a total score.
Measured: Baseline - 22 weeks
Clinical outcomes - Re-hospitalization
Re-hospitalization will be measured at 1-year. This will be accomplished by linking healh card numbers from study participants to administrative data housed at the Institute for Clinical Evaluative Sciences (ICES).
Measured: Baseline - 52 weeks
Clinical outcome - Health care utilization - Number of emergency room and physician visits
The total number of emergency room visits and physician/specialist visits will be tallied at 1-year. This will be accomplished by linking health card numbers from study participants to administrative data housed at the Institute for Clinical Evaluative Sciences (ICES).
Measured: Baseline - 52 weeks
Clinical outcome - mortality
Mortality will be measured at 1-year. This will be accomplished by linking healh card numbers from study participants to administrative data housed at the Institute for Clinical Evaluative Sciences (ICES).
Measured: Baseline - 52 weeks
Cost of Intervention
The costs associated with delivering the VCRP and CMHP interventions will be collected during the study period. All costs will be expressed in Canadian dollars for the year 2017 and evaluated from the perspective of the healthcare system. Costs will be based on real resource use and will include the sum of the costs associated with assessments, coaching, and materials used (e.g., manuals, Garmin monitors).
Measured: Fiscal year 2017 through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start30 Nov 2018
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri Mullen, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696446
- Sponsor's protocol ID
- VCRP-RCT
- Acronym
- VCRP-RCT
- Status last verified
- Aug 2022
- First submitted
- 17 Apr 2018
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
CACPR 2020 Annual Meeting Abstracts. J Cardiopulm Rehabil Prev. 2020 Nov 1;40(6):E52-E57. doi: 10.1097/HCR.0000000000000561. No abstract available.
PubMed 33953036
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility
- ClinicalTrials.gov ID
- NCT03696446
- Acronym / sponsor ID
- VCRP-RCT / VCRP-RCT
- Conditions
- Coronary Heart Disease, Valve Disease, Heart
- Keywords
- Cardiac Rehabilitation, Patient Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 4 Oct 2018 (actual)
- 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.
Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure \& cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website \& Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Cardiac Rehabilitation Program | Experimental | Behavioral: Virtual Cardiac Rehabilitation ProgramThis group will receive access to the NWC (NexJ Connected Wellness TM (NCW) and will be provided with a fitness tracker (Garmin Vivofit 3) to monitor their exercise, sedentary behaviours, and sleep patterns. The NWC platform includes components for education (health library, workbooks etc), collaboration (personal care plan, appointment scheduler, secure messaging system etc), and motivation (motivational messages on their homepage etc). With the Health Coach, participants will engage in: reviews of their risk factor profile and health priorities; goal setting and action planning; problem solving and skill building; and discussions of relapse prevention. Participants will receive a total of seven hours of health coaching delivered across nine sessions over a 26-week period |
| Case Managed Home Program | Other | Behavioral: Case Managed Home ProgramThe Case Managed Home Program (CMHP) is delivered primarily via telephone. Following their CR intake, patients are linked with their CMHP Health Coach and attends their visit (in person or over the phone) which includes a comprehensive review of their health history, current symptoms, medications, activity, and individual concerns. Following this visit, participants will receive a total of 10 individualized telephone calls over a 26 week period. The program action plan is individually formulated based on the participant's goals and learning needs. Participants are provided with educational kits (exercise, nutrition, stress management or prevention) that are based on the principle of single point learning and incorporate behavioural change techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);
- Patient has stable Coronary Heart Disease (CHD) or valvular disease;
- Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;
- Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
- Patient is ≥ 18 years of age (the age of consent in Ontario);
Key exclusion criteria (2 listed)
- Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
- Patient, in the opinion of the medical advisor (Dr. Andrew Pipe), manifests illness that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence).
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 |
|---|---|---|
| Virtual Cardiac Rehabilitation ProgramAlso: Web-based CRThis group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator. | Behavioural | Virtual Cardiac Rehabilitation Program |
| Case Managed Home ProgramAlso: Phone based CRThis group will receive their Rehab program over the phone with a trained facilitator | Behavioural | Case Managed Home Program |
Primary outcome
Patient Activation
Time frame: Baseline - 22 weeks
Patient activation will be measured by the Patient Activation Measure (PAM) questionnaire.This 10-item tool assesses the degree to which a patient is engaged or disengaged with their health and how likely they are to self-manage it.The total score of the tool classifies a participant into one of 4 categories; disengaged and overwhelmed (level 1), becoming aware but still struggling (level 2), taking action (level 3) and maintaining behaviors and pushing further (level 4). Higher levels mean participants are becoming better at, or have fully begun to self-manage their health behaviors.
17 secondary outcomes
Tobacco smoking
Time frame: Baseline - 22 weeks
Physical activity
Time frame: Baseline - 22 weeks
Dietary behaviors
Time frame: Baseline - 22 weeks
Medication adherence
Time frame: Baseline - 22 weeks
Blood pressure
Time frame: Baseline - 22 weeks
Low density lipoprotein cholesterol (LDL-C)
Time frame: Baseline - 22 weeks
High density lipoprotein cholesterol (HDL-C)
Time frame: Baseline - 22 weeks
Total cholesterol (TC)
Time frame: Baseline - 22 weeks
Triglycerides
Time frame: Baseline - 22 weeks
Glycated hemoglobin (A1C)
Time frame: Baseline - 22 weeks
Waist circumference
Time frame: Baseline - 22 weeks
Generic Quality of Life
Time frame: Baseline - 22 weeks
Health Related Quality of Life
Time frame: Baseline - 22 weeks
Clinical outcomes - Re-hospitalization
Time frame: Baseline - 52 weeks
Clinical outcome - Health care utilization - Number of emergency room and physician visits
Time frame: Baseline - 52 weeks
Clinical outcome - mortality
Time frame: Baseline - 52 weeks
Cost of Intervention
Time frame: Fiscal year 2017 through study completion.
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 26 Aug 2022.
- Derived from this study: PubMed 33953036CACPR 2020 Annual Meeting Abstracts. J Cardiopulm Rehabil Prev. 2020 Nov 1;40(6):E52-E57. doi: 10.1097/HCR.0000000000000561. No abstract available.
- Individual participant dataSharing planned: No
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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.
Kerri Mullen principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Cardiac Rehabilitation Program and Case Managed Home Program in people with Coronary Heart Disease and Valve Disease, Heart, run by Ottawa Heart Institute Research Corporation 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 7 inclusion and 2 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 26 Aug 2022. 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?
Patient Activation (time frame: Baseline - 22 weeks). 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 NCT03696446, which also lists 1 linked publication.
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 26 Aug 2022.