E-health Intervention for Cardiac Rehabilitation (VCRP-RCT)
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|ClinicalTrials.gov Identifier: NCT03696446|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Valve Disease, Heart||Behavioral: Virtual Cardiac Rehabilitation Program Behavioral: Case Managed Home Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||The facilitators will not know that the participants are part of the study. Participants will know which group they are allocated to as they are aware of both groups (described in the consent form).|
|Official Title:||E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Virtual Cardiac Rehabilitation Program
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
Behavioral: Virtual Cardiac Rehabilitation Program
This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.
Other Name: Web-based CR
Case Managed Home Program
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.
Behavioral: Case Managed Home Program
This group will receive their Rehab program over the phone with a trained facilitator
Other Name: Phone based CR
- 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.
- Tobacco smoking [ 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.
- Physical activity [ 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.
- Dietary behaviors [ 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).
- Medication adherence [ 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.
- Blood pressure [ 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.
- Low density lipoprotein cholesterol (LDL-C) [ 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.
- High density lipoprotein cholesterol (HDL-C) [ 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.
- Total cholesterol (TC) [ 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.
- Triglycerides [ 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.
- Glycated hemoglobin (A1C) [ 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.
- Waist circumference [ 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.
- Generic Quality of Life [ 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
- Health Related Quality of Life [ 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.
- Clinical outcomes - Re-hospitalization [ 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).
- Clinical outcome - Health care utilization - Number of emergency room and physician visits [ 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).
- Clinical outcome - mortality [ 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).
- Cost of Intervention [ 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).
- Patient Experiences with the VCRP Intervention and online Platform [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696446
|Contact: Evyanne Wooding, BSc||613-696-7000 ext firstname.lastname@example.org|
|Contact: Aaron Brautigam, BSc||613-696-7000 ext email@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Evyanne Wooding 613-696-7000 ext 17596 firstname.lastname@example.org|
|Principal Investigator:||Bob Reid||Ottawa Heart Institute Research Corporation|