the Canadian Health Improvement Network to Upgrade Prevention Services (CHIN-UPS)
|ClinicalTrials.gov Identifier: NCT02310685|
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : August 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Other: Comprehensive e-health wellness program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||459 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Canadian Health Improvement Network to Upgrade Prevention Services (CHIN-UPS) - Evaluating a Multidisciplinary Health Promotion Program.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||June 2019|
Active Comparator: 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.
Other: Comprehensive e-health wellness program
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".
No Intervention: 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.
- Weight loss/exercise [ Time Frame: April 2015 to October 2017, up to 28 months ]Weight loss/exercise will be measured and assessed at 3, 6, and 12 months.
- Blood Pressure [ Time Frame: April 2015 to October 2017, up to 28 months ]Blood pressure will be measured at baseline, 3, 6 and 12 months.
- Drop-out rates [ Time Frame: April 2015 to October 2017, up to 28 months ]drop out rates in each arm
- Medication adherence [ Time Frame: April 2015 to October 2017, up to 28 months ]Medication adherence will be analysed
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310685
|Principal Investigator:||Steven A Grover, MD MPA FRCPC||McGill University|