The Canadian Health Improvement Network to Upgrade Prevention Services (CHIN-UPS) - Evaluating a Multidisciplinary Health Promotion Program.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 主要终点
- Weight loss/exercise
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between the ages of 40-75 years
- •Overweight defined as BMI > 27
- •Sedentary Lifestyle (less than 3 hours of moderate physical activity per week)
- •Access to Internet daily
- •Speak and read English or French
排除标准
- •Unable to sign informed consent
- •Have a health condition that would exclude them from being able to safely lose 10 lbs if their BMI is >27 kg/m2 OR to exercise daily at a moderate intensity (equivalent to brisk walking) for at least 30 minutes
- •Note: All individuals are eligible to participate in the program; however only those who meet the inclusion criteria will be included in the analysis. Those who meet the exclusion criteria will not be included in the analysis. Pregnant women and individuals who answered yes to the safety questionnaire will receive the following message on the website and in an email: If you answered yes to any of the exercise safety questions, we recommend that you obtain clearance from your physician prior to changing your exercise program. Individuals will tick a box "I have read this message"
研究组 & 干预措施
Intervention
Active Comparator: Intervention The primary focus is CVD risk factors. Subjects will be shown how to update Cardiovascular Age or Cardiometabolic Age on website. Pharmacists will give overview of comprehensive ehealth wellness program. Subjects will complete additional health assessments which include questionnaires considered gold standard. Pharmacists will explain that participants have access to ehealth coaching based educational modules with information relevant to a better understanding of cardiovascular risk factors. The ehealth coaching modules are guides to help understand risk factors and importance of making lifestyle changes. As information alone is often insufficient to promote change, participants will have access to online physical activity challenges.
干预措施: Comprehensive e-health wellness program (Other)
No Intervention
Individuals randomized to the non active intervention group will have access to modified version of ehealth website. The pharmacist will show participants how to update Cardiovascular Age or Cardiometabolic Age on website. They will have access to health assessments but not ehealth coaching educational modules or challenges. They will have online support tools including public domain education material on exercise, healthy eating, understanding and managing blood pressure, diabetes and smoking cessation. Participants will return to the pharmacist for follow-up visits at 3, 6 months and one year. The pharmacist will update their cardiovascular risk profile with current information At the first follow up visit and at 1 year participants will be asked to have blood lipids reassessed.
结局指标
主要结局
Weight loss/exercise
时间窗: April 2015 to October 2017, up to 28 months
Weight loss/exercise will be measured and assessed at 3, 6, and 12 months.
次要结局
- Drop-out rates(April 2015 to October 2017, up to 28 months)
- Medication adherence(April 2015 to October 2017, up to 28 months)
- Blood Pressure(April 2015 to October 2017, up to 28 months)
研究者
Steven Grover, MD
Steven A. Grover, MD, MPA, FRCPC
McGill University