University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
NCT Number: NCT03696446
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ottawa, Ontario, K1Y 4W7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.
Other names: Web-based CR
This group will receive their Rehab program over the phone with a trained facilitator
Other names: Phone based CR
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.
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 22 weeks
Physical activity will be measured by pedometer. Participants will wear the pedometer for 7 days at baseline and again at 22 week follow up.
Time frame: Baseline - 22 weeks
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).
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 22 weeks
Blood pressure will be measured and recorded in millimeters of mercury. A high measured will be considered 140/90 or higher.
Time frame: Baseline - 22 weeks
LDL-C will be measured and reported in millimoles per litre (mmol/L). Measures < 3.5 mmol/L are considered desirable.
Time frame: Baseline - 22 weeks
HDL-C will be measured and reported in millimoles per litre (mmol/L). Measures above 1.3 mmol/L are considered desirable.
Time frame: Baseline - 22 weeks
TC will be measured and reported in millimoles per litre (mmol/L). Measures less than 5.2 mmol/L are considered desirable.
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 22 weeks
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
Time frame: Baseline - 22 weeks
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.
Time frame: Baseline - 52 weeks
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).
Time frame: Baseline - 52 weeks
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).
Time frame: Baseline - 52 weeks
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).
Time frame: Fiscal year 2017 through study completion.
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).
Time frame: Baseline - 22 weeks
Patient's experiences will be assessed through focus group sessions. Participation is optional. Participants will be asked about their experiences with the VCRP, their acceptability and satisfaction with the VCRP, and suggestions for improvement. Participants will all be asked specific questions related to the VCRP platform but then given time to provide more general comments. The focus group questions will all be assembled by one of the Co-Investigators who has experience conducting focus group sessions. The Co-I will transcribe all focus group conversations and generate common themes. There are no score-able questionnaires being used during focus group sessions. These sessions are qualitative in nature.
Ottawa Heart Institute Research Corporation
Other
E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility
Acronym: VCRP-RCT
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