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the Canadian Health Improvement Network to Upgrade Prevention Services (CHIN-UPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310685
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Grover, MD, McGill University

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: Comprehensive e-health wellness program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Drop-out rates [ Time Frame: April 2015 to October 2017, up to 28 months ]
    drop out rates in each arm

  3. Medication adherence [ Time Frame: April 2015 to October 2017, up to 28 months ]
    Medication adherence will be analysed



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female between the ages of 40-75 years
  2. Overweight defined as BMI > 27
  3. Sedentary Lifestyle (less than 3 hours of moderate physical activity per week)
  4. Access to Internet daily
  5. Speak and read English or French

Exclusion Criteria:

  1. Unable to sign informed consent
  2. Pregnant
  3. 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"


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310685


Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Steven A Grover, MD MPA FRCPC McGill University
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Steven Grover, MD, Steven A. Grover, MD, MPA, FRCPC, McGill University
ClinicalTrials.gov Identifier: NCT02310685    
Other Study ID Numbers: A10-M75-14B
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Steven Grover, MD, McGill University:
Cardivascular risks (hypertension, sedentary, overweight)
Cardiovascular age
E-health wellness program
Prevention
Community pharmacists
Lifestyle change
Cardiometabolic age
Additional relevant MeSH terms:
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Cardiovascular Diseases