the Canadian Health Improvement Network to Upgrade Prevention Services
NCT02310685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 459
Last updated 2019-08-13
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.
Conditions
Interventions
- 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".
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Steven A Grover, MD MPA FRCPC · McGill University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2018-09-30
- Completion
- 2019-06-30
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