the Canadian Health Improvement Network to Upgrade Prevention Services
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      RATIONALE Controlling cardiovascular risk factors has been proven to be effective in
      prevention and management of cardiovascular disease (CVD). Nonetheless, significant treatment
      gaps have been demonstrated repeatedly in numerous surveys. A recent study of Canadian adults
      filling prescriptions for hypertension or dyslipidemia demonstrated that the majority
      remained overweight and sedentary despite being at risk of developing CVD. Medication
      adherence has been shown to be poor with up to 50% of patients stopping therapy after one
      year.

      Patient-centred care can lead to improved clinical management and patient satisfaction.
      Adherence with prescribed therapy can also be improved if individuals understand the
      importance of their risk factors, are aware of their overall health status and participate in
      decision making surrounding pharmacotherapy and lifestyle changes.

      Community pharmacists are frontline healthcare professionals who can identify patients at
      risk of CVD, assess their adherence with recommended lifestyle behaviours or drug therapy and
      engage them in shared decision making surrounding health promotion strategies. Local
      pharmacies could effectively become readily accessible community health centres nationwide.

      Research Objectives. The primary objective is to evaluate, in a randomized clinical trial,
      the impact of a community pharmacy intervention to improve the management of cardiovascular
      risk factors vs a basic e-health education program. The intervention will include a
      cardiovascular or cardiometabolic risk assessment providing the individual with their
      Cardiovascular or Cardiometabolic Age. Individuals at increased risk of CVD and/or with
      modifiable risk factors will also be offered a one year subscription to a multidisciplinary,
      pharmacy based, e-health promotion program to improve management of CVD risk factors such as
      weight loss and increased physical activity and track their progress in managing their risk
      factors and reducing their Cardiovascular or cardiometabolic Age. Changes in CVD risk
      factors, Cardiovascular/cardiometabolic Age, and uptake or adherence to medications and
      lifestyle changes will be examined 3 months, 6 months and one year post intervention.

      Study Hypothesis. Investigators hypothesize that engaging patients in a discussion of their
      Cardiovascular or Cardiometabolic Age and management of their risk factors will result in
      improved healthy lifestyle habits moreover increased physical activity and weight loss.
    

Detailed description: 
      Twelve hundred subjects will be recruited from 30 to 60 pharmacies across Canada each
      providing 20 to 40 study subjects. Recruitment will occur over 18 months.

      Shoppers Drug Mart and Sobeys/Lawtons are chain pharmacies that have agreed to participate in
      the study and will identify a minimum of 20 and 10 pharmacies from within their chains
      respectively. Pharmacy contacts will be sent summary of the research project and will be
      invited to participate by senior management through internal company communications.
      Additional pharmacies will be included in the study if additional funding to remunerate the
      pharmacists becomes available.

      A pharmacy will be eligible to participate if it has an automated blood pressure system, a
      calibrated weight scale, a consultation area with a computer, internet access and the
      pharmacist is willing to recruit and enroll at least 20 patients.

      Once a pharmacist has agreed to participate, pharmacist will be asked to participate in a
      conference call. A one-hour training webinar will be provided to the pharmacists prior to
      initiating recruitment. Each pharmacist will have access to the website so that pharmacist
      can try the health assessments, read the e-health coaching educational modules and personally
      participate in the health challenges. Pharmacist will be given access to a series of online
      training modules for cardiovascular/cardiometabolic risk assessments and how to engage
      patients to improve lifestyle behaviours such as exercise, weight loss and smoking cessation.
      Pharmacists responsibilities will include taking the participant's blood pressure, weight and
      waist measurements and enabling the participant to get recent blood lipids. The pharmacist
      will also interpret their cardiovascular/cardiometabolic risk profile and provide patient
      with the appropriate educational materials. This visit is expected to take 20-25 minutes.
      Pharmacists will also be encouraged to have participants return for follow-up visits every 3
      months to discuss strategies to achieve their behaviour change goals and review results.

      Subjects will be recruited by the pharmacist or pharmacy staff using number of strategies.

        1. Study recruitment will be promoted within each pharmacy using flyers and posters. Any
           individual at increased cardiovascular risk who is interested in reducing their
           cardiovascular risk by losing excess body weight or increasing their fitness level will
           be encouraged to view study information and register directly on the website.

        2. Individuals who are sedentary, overweight will be invited to enroll in the study by
           registering on website.

        3. Recruited subjects can promote the program to friends and family members. In such cases,
           they will be allocated to the same treatment group.

      Study procedures Individuals will be invited to register on myhealthcheckup website. Access
      to their account will be limited to the participant, members of the research team and their
      local pharmacist. Those who are interested in participating will be asked to sign the online
      informed consent form. Participants will be asked to complete a health assessment for
      heart/diabetes and fitness. Included in this assessment are two validated questionnaires
      including The International Physical Activity Questionnaire and the Self-Efficacy for
      Lifestyle Behaviour Change Questionnaire and the questions required to determine if the
      participant can exercise safely. Additional health assessments will be completed at study
      entry and all of the assessments will be repeated at 3 months, 6 months, and one year post
      intervention.

      Once the individuals have registered, signed Informed Consent Form and completed the
      myhealthcheckup assessments, participants will select their pharmacist from a list provided
      on the website and they will schedule their initial appointment with their pharmacist.
      Selecting a health coach or pharmacist is optional.

      The initial visit with the pharmacist will take approximately 20 to 25 minutes. During this
      visit, participants will be informed that more than one intervention is being evaluated and
      that they have been randomly assigned to only one. More specifically, they have been assigned
      to either the comprehensive e-health wellness program or the basic e-health education
      program. Randomization will occur at registration. The pharmacist will take the patient's
      blood pressure, weight and waist measurements, will interpret the patient's
      cardiovascular/cardiometabolic risk profile and discuss a plan of action. Each participant
      will be provided with baseline cardiovascular or cardiometabolic risk assessment. Both the
      active intervention and the non-active intervention groups will have access to their
      cardiovascular or cardiometabolic risk profile, including their calculated
      cardiovascular/cardiometabolic age. It provides their estimated 10-year risk of developing
      cardiovascular disease and compares this result to Canadians of the same age and gender. The
      risk profile will be interpreted by pharmacist.

      Most of the information required for baseline cardiovascular risk assessment will be provided
      by the participant. Clinical information will include: age, gender, presence of previously
      diagnosed cardiovascular diseases including coronary heart disease, cerebrovascular disease
      or lower extremity peripheral arterial disease; previously diagnosed diabetes, family history
      of premature cardiovascular disease, smoking status, use of antihypertensive medication and
      self-reported weekly exercise. Required clinical information includes resting blood pressure,
      height, weight, waist circumference, and non-fasting cholesterol values. Blood pressure will
      be measured. When actual lipid values are not known, the Framingham and Cardiovascular Age
      risk profiles will be completed using the median lipid values for Canadians of same age and
      gender and each participant will be told to ask their doctor for most recent values to update
      their record and allow a more accurate risk assessment to be completed by the patient at home
      online (intervention group only) or during their next visit to the pharmacy. This initial
      visit should take 20-25 minutes.

      Both groups of patients will be asked to return to their pharmacist after 3 months, 6 months
      and 1 year for follow-up visit to have their cardiovascular risk profile updated. At each
      visit, blood pressure, weight and waist circumference will be measured and any changes in
      other risk factors will be noted. Each participant's progress will be evaluated during the
      follow-up visits.

      Active Intervention: Comprehensive e-health wellness program Given the primary focus on CVD
      risk factors, each subject will be shown by the pharmacist how to update their Cardiovascular
      or Cardiometabolic Age on website. Pharmacists will give subjects brief overview of what the
      comprehensive e-health wellness program website has to offer them. Patients will be shown
      that in addition to the cardiovascular or cardiometabolic risk, diabetes and fitness
      assessments, they will be able to complete eight additional health assessments at entry into
      the study and as they see fit. All of the assessments employ questionnaires considered the
      gold standard for evaluating each of the respective health conditions which include: 1)
      smoking and nicotine dependence 2) alcohol abuse and dependence 3) sleep 4) depression 5)
      stress 6) fitness 7) nutrition and 8) body weight. Subjects will have access to summary of
      health status results and identify where there is room for improvement according to current
      disease treatment guidelines.

      The pharmacist will explain that participants have access to ehealth coaching based
      educational modules with information relevant to a better understanding of exercise, weight
      loss, hypertension, dyslipidemia and diabetes and how to improve other areas such as sleep,
      stress management, and smoking cessation. The goal of these ehealth coaching modules are
      designed to encourage the individual to remain engaged and to take charge of their physical
      and mental health by increasing their physical activity, making healthy food choices and
      learning tools to decrease stress and improve sleep habits. Participants will receive daily
      health tips.

      As information alone is often insufficient to promote behaviour change, participants will
      have access to online physical activity challenges designed to motivate the user to engage in
      regular exercise. The challenges provide tracking tools to facilitate the subject's
      monitoring of their progress. Physical activity challenges can be designed to engage the
      subject as a member of an online team. Participants can also compete individually in specific
      challenges. Individuals participating in a team challenge will be asked to provide a
      pseudonym to protect anonymity. Participants will have 24/7 access to their health record and
      be encouraged to use the website to evaluate a range of health assessments, receive
      information about specific health conditions, or engage in the online activity challenges.
      Subjects can review what the pharmacist explained to them concerning the website by viewing a
      brief video that will be provided on the website home page.

      Non-active intervention: Basic e-health education program Individuals randomized to the
      non-active intervention group will be provided with access to a modified version of the
      e-health website.

      Each participant will be shown by the pharmacist how to update their Cardiovascular Age or
      Cardiometabolic Age on the website. Participants will have access to other health assessments
      but not the ehealth coaching based educational modules or the challenges. Instead
      participants will be provided on-line support tools including public domain education
      material such as handouts on exercise, healthy eating, understanding and managing blood
      pressure, diabetes and smoking cessation. These are currently available from the Public
      Health Association of Canada. Participants will be asked to see their pharmacist for a
      follow-up visit at 3 months, 6 months and one year. During these visits the pharmacist will
      update participants' cardiovascular or cardiometabolic risk profile with current clinical
      information including a measured blood pressure and weight. At the first follow-up visit and
      at 1 year, all participants will be asked to have their blood lipids re-assessed.
    

Intervention name(s): Comprehensive e-health wellness program
Intervention type(s): Other
Intervention description(s): Participants randomized to this arm will have complete access to the myhealthcheckup website equipped with online tools including health assessments with coaching modules, educational material with quizzes, exercise challenges and motivational tips. The subject will meet with the pharmacist on 4 occasions (initial, 3, 6, 12 months) to update the cardiovascular risk profile, BP, weight, waist circumference and lipid profile. All interventions that were prespecified to be administered as part of the protocol, even if a particular intervention is not "of interest".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cardivascular risks (hypertension, sedentary, overweight); Cardiovascular age; E-health wellness program; Prevention; Community pharmacists; Lifestyle change; Cardiometabolic age