the Canadian Health Improvement Network to Upgrade Prevention Services

NCT02310685 | Completed DMC

• 1 other identifier: A10-M75-14B
• Study Type: interventional
• Target: 459
• Locations: 0 countries
• Sites: N/A

Brief 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

Cardiovascular Disease

Keywords

Cardivascular risks (hypertension, sedentary, overweight); Cardiovascular age; E-health wellness program; Prevention; Community pharmacists; Lifestyle change; Cardiometabolic age

Outcome Measures

Primary Outcomes (1)

• Weight loss/exercise

  Weight loss/exercise will be measured and assessed at 3, 6, and 12 months.

  April 2015 to October 2017, up to 28 months

Secondary Outcomes (3)

• Blood Pressure

  April 2015 to October 2017, up to 28 months

• Drop-out rates

  April 2015 to October 2017, up to 28 months

• Medication adherence

  April 2015 to October 2017, up to 28 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

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.

Interventions

Comprehensive e-health wellness program OTHER

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".

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to sign informed consent
• Pregnant
• 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

Sponsors & Collaborators

• McGill University: lead

Related Publications (10)

• Grover SA, Lowensteyn I, Joseph L, Kaouache M, Marchand S, Coupal L, Boudreau G. Discussing coronary risk with patients to improve blood pressure treatment: secondary results from the CHECK-UP study. J Gen Intern Med. 2009 Jan;24(1):33-9. doi: 10.1007/s11606-008-0825-4. Epub 2008 Oct 21.

  PMID: 18937013 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

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  PMID: 8329970 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Myers JK, Weissman MM. Use of a self-report symptom scale to detect depression in a community sample. Am J Psychiatry. 1980 Sep;137(9):1081-4. doi: 10.1176/ajp.137.9.1081.

  PMID: 7425160 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Gans KM, Risica PM, Wylie-Rosett J, Ross EM, Strolla LO, McMurray J, Eaton CB. Development and evaluation of the nutrition component of the Rapid Eating and Activity Assessment for Patients (REAP): a new tool for primary care providers. J Nutr Educ Behav. 2006 Sep-Oct;38(5):286-92. doi: 10.1016/j.jneb.2005.12.002.

  PMID: 16966049 BACKGROUND

• Grover S, Coupal L, Kouache M, Lowensteyn I, Marchand S, Campbell N. Estimating the benefits of patient and physician adherence to cardiovascular prevention guidelines: the MyHealthCheckup Survey. Can J Cardiol. 2011 Mar-Apr;27(2):159-66. doi: 10.1016/j.cjca.2011.01.007.

  PMID: 21459263 RESULT

• Grover SA, Lowensteyn I, Joseph L, Kaouache M, Marchand S, Coupal L, Boudreau G; Cardiovascular Health Evaluation to Improve Compliance and Knowledge Among Uninformed Patients (CHECK-UP) Study Group. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial. Arch Intern Med. 2007 Nov 26;167(21):2296-303. doi: 10.1001/archinte.167.21.2296.

  PMID: 18039987 RESULT

Related Links

• myhealthcheckup website

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Sedentary Behavior; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven A Grover, MD MPA FRCPC

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven A. Grover, MD, MPA, FRCPC

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 8, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share