Cardiovascular Risk FactorCASPNCT03170752
Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)
A study testing Cardiovascular Assessment Screening Program (CASP) in people with Cardiovascular Risk Factor and Smoking, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
This study is a randomized controlled trial (RCT) and there will be two groups: an intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and Labrador (NL) who agree to participate will be randomly assigned to one of the two groups. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Smoking, Diabetes Mellitus
- What is being tested?
- Cardiovascular Assessment Screening Program (CASP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2017to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employment as a full-time NP in community-based settings
- Access to healthy, asymptomatic patients between the ages of 40-74 years of age
- Ability of the practice to collect data.
- Eligible based on age,
- No established CVD (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE).
- Willingness to participate in the study.
Who cannot join
- Age less than 20 or over 75 years
- Established Cardiovascular Disease (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE)).
- Inability to attend NP clinic visit
Trial locations and contacts
1 site in 1 country.
Canada1 site
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B3V6
About this study
Official title: Implementing and Testing a Cardiovascular Assessment Screening Program to Promote Healthy Aging (CASP)
This study is a randomized controlled trial (RCT) and there will be two groups: an intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and Labrador (NL) who agree to participate will be randomly assigned to one of the two groups. The NPs in the intervention group will be asked to screen about 30 individuals aged 40-74 years without established cardiovascular disease (CVD) that currently come to their clinics. The NPs will be asked to screen these patients for CVD using a set of specific data collection tools that will be in electronic format. The control group will carry on with usual practice. Their charts will be reviewed by the researchers at a later date. At the end of the study, the screening program, with tools and strategies for CVD screening, will be given to NPs in the control group.
Read the detailed description
The RCT will be conducted to test the screening intervention, the Cardiovascular Assessment Screening Program, with nurse practitioners across NL.
Research Questions
- What is the effect of implementing the Cardiovascular Assessment Screening Program on comprehensiveness of screening by nurse practitioners in NL?
- What is the effect of implementation of the Cardiovascular Assessment Screening Program on the identification of individuals at high risk of CVD within the nurse practitioner practice?
- What is the effect of implementation of the Cardiovascular Assessment Screening Program on recommendations that are made by nurse practitioners in NL?
- What components of the Cardiovascular Assessment Screening Program are effective in promoting CVD screening and appropriate follow-up by nurse practitioners in NL?
- What are the patients' and nurse practitioners' factors that influence participation in the Cardiovascular Assessment Screening Program in NL? The main outcome is the comprehensiveness of CVD screening. The null hypothesis for the RCT is stated as follows: There will be no difference in comprehensiveness of screening between the intervention group and the control group.
Methodology The RCT study will involve implementation and evaluation of the Cardiovascular Assessment Screening Program across the province of NL. The RCT will use block randomization following NP recruitment to allocate participating NP practices to either the intervention group or the control group. The NPs in the intervention group will participate in scheduled face-to-face educational sessions as well as webinars from their workplaces to receive support on using specific tools to identify, screen, and follow-up with patients. The NPs will also receive instructions on data collection methods using the study's Access Database developed by Newfoundland and Labrador Centre for Health Information (NLCHI).
The NPs in the control group will participate in a webinar education session and will be instructed to follow usual practice to screen patients for CVD. The NPs in the control group will receive instructions on keeping a record of patients who were seen in their clinics and whether or not the patients will be eligible to participate in the study based on age and history. This information will be used by researchers to conduct a retrospective chart review on a specified date during the data collection period. The specific CVD screening tools provided to the NPs in the intervention group will be made available to NPs in the control group following conclusion of this study.
Setting \& Sample The RCT will take place in community-based clinics with NP practices from both rural and urban areas in the various regional health authorities across NL. NPs may be working in solo practice or working with several other NPs in a group practice. There will be four types of NP practices: 1) rural solo, 2) rural group, 3) urban solo and, 4) urban group. NPs working in the same group practice will need to be allocated to the same group, so block randomization will be used once all of the NP practices have been recruited. Using a random number generator, NP practices will be allocated to either the intervention group or the control group within each block (type) of practice.
The sample size estimation for this study was determined using the proportion of eligible patients who were comprehensively screened as the outcome measure of interest. A study that considered the effectiveness of a national risk assessment program for patients aged 40-74 years found that approximately 40% had complete Health Checks and 60% had partial Health Checks among high risk patients in the United Kingdom (UK) National Health Service Health Check Program (Artec et al., 2013). The sample size for this proposed study was calculated based on the assumption that 40% of the screening will be comprehensive in the control group practices. The research team decided that comprehensive screening of 70% of patients seen by the NPs in the intervention group during this study would indicate an effective intervention. Using a two-sided alpha of 0.05 and 90% power, the sample size was calculated to be 250 patients (125 patients per group). Considering that patients would need to provide consent to participate in this study the research team assumed that 20% of those approached would refuse. This means that 300 patients with 150 patients per group would be required. To be realistic about workload, each NP would need to include 25-30 patients. A minimum of 10 NPs therefore needs to be recruited. The duration of the data collection period will vary by NP according to the number of eligible patients seen. For example, if an NP sees one eligible patient per day for five days a week, then the data collection period would be six weeks for a total of 30 patients. If an NP sees two eligible patients per day, then the data collection period would be three weeks.
- Conditions
- Cardiovascular Risk Factor, Smoking, Diabetes Mellitus, Dyslipidemias, Hypertension, Physical Activity
- Being tested
- Cardiovascular Assessment Screening Program (CASP)
- Keywords
- RCT, Cardiovascular Risk Factors, Screening
- Medical subject headings
- Smoking, Diabetes Mellitus, Dyslipidemias, Hypertension, Motor Activity, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Assessment Screening Program (CASP)Behavioural
Step 1. Identification of patients; Step 2. Screening utilizing appropriate tools; and Step 3. Actions to follow up on the screening results.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The screening intervention Cardiovascular Assessment Screening Program (CASP) to be implemented by NPs in the intervention group has three steps:
1. Identification of patients (using Eligibility for Heart Health Screening Form, Heart Health Assessment Pamphlet, Tracking Form for Heart Health Screening, Algorithm for NP to Screen);
2. Screening utilizing appropriate tools (Cardiovascular Screening Checklist, Heart Health Screening Website/App);
3. Actions to follow up on the screening results (Heart Health Screening Website/App, CV Decision Tree Algorithm). Receives: Behavioral: Cardiovascular Assessment Screening Program (CASP) |
| Control group | No intervention | The NPs in the control group will be instructed to follow usual practice to screen patients for cardiovascular disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are comprehensively screened to the number of eligible patients seen in the intervention group compared to the control group as assessed by the completeness of CV Screening Checklist data collection form.
If the CV screening Checklist is only partially completed or not completed at all then it will not be considered comprehensive. Logistic regression is used because the outcome is dichotomous (yes or no). The patients had comprehensive screening (Yes) or they did not have comprehensive screening (No).
Measured: 6-8 weeks
Secondary outcomes (3)
Identification of individuals at high risk for cardiovascular disease as assessed by the calculated Framingham Risk Score.
The Framingham Risk Scores of patients in the intervention group will be calculated using an online calculator and the number of high risk individuals will be identified and reported.
Measured: 6-8 weeks
The management recommendations that are made by the NPs as assessed by the responses collected on the CV Screening Checklist data collection form (intervention group) and the chart review (control group).
Chi Square will be used to compare the recommendations made by NPs in the intervention group compared to the NPs in the control group following screening of patients for cardiovascular disease.
Measured: 6-8 weeks
The patient and NP factors that influence participation in the CASP as assessed by content analysis of patient and NP feedback questionnaires.
The responses from the Patient and NP Feedback Questionnaires will be assessed using content analysis to determine the factors that influence participation in the screening intervention Cardiovascular Assessment Screening Program (CASP).
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start28 Sep 2017
- Primary completion29 Sep 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Bruneau, Memorial University of Newfoundland
- Investigators
- Jill Bruneau, PhD(c), Principal investigator, Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170752
- Sponsor's protocol ID
- 20180318
- Acronym
- CASP
- Status last verified
- Mar 2019
- First submitted
- 24 May 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez-Bueno C, Cavero-Redondo I, Martinez-Andres M, Arias-Palencia N, Ramos-Blanes R, Salcedo-Aguilar F. Effectiveness of multifactorial interventions in primary health care settings for primary prevention of cardiovascular disease: A systematic review of systematic reviews. Prev Med. 2015 Jul;76 Suppl:S68-75. doi: 10.1016/j.ypmed.2014.11.028. Epub 2014 Dec 12.
PubMed 25511466Artac M, Dalton AR, Majeed A, Car J, Millett C. Effectiveness of a national cardiovascular disease risk assessment program (NHS Health Check): results after one year. Prev Med. 2013 Aug;57(2):129-34. doi: 10.1016/j.ypmed.2013.05.002. Epub 2013 May 21.
PubMed 23701848Avanzini F, Marzona I, Baviera M, Barlera S, Milani V, Caimi V, Longoni P, Tombesi M, Silletta MG, Tognoni G, Roncaglioni MC; Risk and Prevention Study Collaborative Group. Improving cardiovascular prevention in general practice: Results of a comprehensive personalized strategy in subjects at high risk. Eur J Prev Cardiol. 2016 Jun;23(9):947-55. doi: 10.1177/2047487315613664. Epub 2015 Nov 2.
PubMed 26525065Brindle P, Beswick A, Fahey T, Ebrahim S. Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review. Heart. 2006 Dec;92(12):1752-9. doi: 10.1136/hrt.2006.087932. Epub 2006 Apr 18.
PubMed 16621883Cardiometabolic Risk Working Group: Executive Committee; Leiter LA, Fitchett DH, Gilbert RE, Gupta M, Mancini GB, McFarlane PA, Ross R, Teoh H, Verma S, Anand S, Camelon K, Chow CM, Cox JL, Despres JP, Genest J, Harris SB, Lau DC, Lewanczuk R, Liu PP, Lonn EM, McPherson R, Poirier P, Qaadri S, Rabasa-Lhoret R, Rabkin SW, Sharma AM, Steele AW, Stone JA, Tardif JC, Tobe S, Ur E. Identification and management of cardiometabolic risk in Canada: a position paper by the cardiometabolic risk working group (executive summary). Can J Cardiol. 2011 Mar-Apr;27(2):124-31. doi: 10.1016/j.cjca.2011.01.016.
PubMed 21459258Tobe SW, Stone JA, Walker KM, Anderson T, Bhattacharyya O, Cheng AY, Gregoire J, Gubitz G, L'Abbe M, Lau DC, Leiter LA, Oh P, Padwal R, Poirier L, Selby P, Tremblay M, Ward RA, Hua D, Liu PP; C-CHANGE Initiative. Canadian Cardiovascular Harmonized National Guidelines Endeavour (C-CHANGE): 2014 update. CMAJ. 2014 Nov 18;186(17):1299-305. doi: 10.1503/cmaj.140387. Epub 2014 Oct 20. No abstract available.
PubMed 25332362Bruneau J, Moralejo D, Parsons K. Evaluating the effectiveness of the cardiovascular assessment screening program with nurse practitioners and patients: results of a cluster randomised controlled trial. BMC Prim Care. 2024 May 24;25(1):185. doi: 10.1186/s12875-024-02432-2.
PubMed 38789927
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Testing a Cardiovascular Assessment Screening Program to Promote Healthy Aging (CASP)
- ClinicalTrials.gov ID
- NCT03170752
- Acronym / sponsor ID
- CASP / 20180318
- Conditions
- Cardiovascular Risk Factor, Smoking, Diabetes Mellitus, Dyslipidemias, Hypertension, Physical Activity
- Keywords
- RCT, Cardiovascular Risk Factors, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial (RCT) and there will be two groups: an intervention group and a control group. Nurse practitioners (NPs) across Newfoundland and Labrador (NL) who agree to participate will be randomly assigned to one of the two groups. The NPs in the intervention group will be asked to screen about 30 individuals aged 40-74 years without established cardiovascular disease (CVD) that currently come to their clinics. The NPs will be asked to screen these patients for CVD using a set of specific data collection tools that will be in electronic format. The control group will carry on with usual practice. Their charts will be reviewed by the researchers at a later date. At the end of the study, the screening program, with tools and strategies for CVD screening, will be given to NPs in the control group.
Detailed description
The RCT will be conducted to test the screening intervention, the Cardiovascular Assessment Screening Program, with nurse practitioners across NL.
Research Questions
- What is the effect of implementing the Cardiovascular Assessment Screening Program on comprehensiveness of screening by nurse practitioners in NL?
- What is the effect of implementation of the Cardiovascular Assessment Screening Program on the identification of individuals at high risk of CVD within the nurse practitioner practice?
- What is the effect of implementation of the Cardiovascular Assessment Screening Program on recommendations that are made by nurse practitioners in NL?
- What components of the Cardiovascular Assessment Screening Program are effective in promoting CVD screening and appropriate follow-up by nurse practitioners in NL?
- What are the patients' and nurse practitioners' factors that influence participation in the Cardiovascular Assessment Screening Program in NL? The main outcome is the comprehensiveness of CVD screening. The null hypothesis for the RCT is stated as follows: There will be no difference in comprehensiveness of screening between the intervention group and the control group.
Methodology The RCT study will involve implementation and evaluation of the Cardiovascular Assessment Screening Program across the province of NL. The RCT will use block randomization following NP recruitment to allocate participating NP practices to either the intervention group or the control group. The NPs in the intervention group will participate in scheduled face-to-face educational sessions as well as webinars from their workplaces to receive support on using specific tools to identify, screen, and follow-up with patients. The NPs will also receive instructions on data collection methods using the study's Access Database developed by Newfoundland and Labrador Centre for Health Information (NLCHI).
The NPs in the control group will participate in a webinar education session and will be instructed to follow usual practice to screen patients for CVD. The NPs in the control group will receive instructions on keeping a record of patients who were seen in their clinics and whether or not the patients will be eligible to participate in the study based on age and history. This information will be used by researchers to conduct a retrospective chart review on a specified date during the data collection period. The specific CVD screening tools provided to the NPs in the intervention group will be made available to NPs in the control group following conclusion of this study.
Setting \& Sample The RCT will take place in community-based clinics with NP practices from both rural and urban areas in the various regional health authorities across NL. NPs may be working in solo practice or working with several other NPs in a group practice. There will be four types of NP practices: 1) rural solo, 2) rural group, 3) urban solo and, 4) urban group. NPs working in the same group practice will need to be allocated to the same group, so block randomization will be used once all of the NP practices have been recruited. Using a random number generator, NP practices will be allocated to either the intervention group or the control group within each block (type) of practice.
The sample size estimation for this study was determined using the proportion of eligible patients who were comprehensively screened as the outcome measure of interest. A study that considered the effectiveness of a national risk assessment program for patients aged 40-74 years found that approximately 40% had complete Health Checks and 60% had partial Health Checks among high risk patients in the United Kingdom (UK) National Health Service Health Check Program (Artec et al., 2013). The sample size for this proposed study was calculated based on the assumption that 40% of the screening will be comprehensive in the control group practices. The research team decided that comprehensive screening of 70% of patients seen by the NPs in the intervention group during this study would indicate an effective intervention. Using a two-sided alpha of 0.05 and 90% power, the sample size was calculated to be 250 patients (125 patients per group). Considering that patients would need to provide consent to participate in this study the research team assumed that 20% of those approached would refuse. This means that 300 patients with 150 patients per group would be required. To be realistic about workload, each NP would need to include 25-30 patients. A minimum of 10 NPs therefore needs to be recruited. The duration of the data collection period will vary by NP according to the number of eligible patients seen. For example, if an NP sees one eligible patient per day for five days a week, then the data collection period would be six weeks for a total of 30 patients. If an NP sees two eligible patients per day, then the data collection period would be three weeks.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cardiovascular Assessment Screening Program (CASP)The screening intervention Cardiovascular Assessment Screening Program (CASP) to be implemented by NPs in the intervention group has three steps: 1. Identification of patients (using Eligibility for Heart Health Screening Form, Heart Health Assessment Pamphlet, Tracking Form for Heart Health Screening, Algorithm for NP to Screen); 2. Screening utilizing appropriate tools (Cardiovascular Screening Checklist, Heart Health Screening Website/App); 3. Actions to follow up on the screening results (Heart Health Screening Website/App, CV Decision Tree Algorithm). |
| Control group | No intervention | –The NPs in the control group will be instructed to follow usual practice to screen patients for cardiovascular disease. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Employment as a full-time NP in community-based settings
- Access to healthy, asymptomatic patients between the ages of 40-74 years of age
- Ability of the practice to collect data.
- Eligible based on age,
- No established CVD (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE).
Key exclusion criteria (3 listed)
- Age less than 20 or over 75 years
- Established Cardiovascular Disease (such as coronary heart disease (CHD) or ischemic heart disease (IHD), myocardial infarctions (MIs), congestive heart failure (CHF), transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), peripheral vascular disease (PVD), and pulmonary emboli (PE)).
- Inability to attend NP clinic visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Assessment Screening Program (CASP)Step 1. Identification of patients; Step 2. Screening utilizing appropriate tools; and Step 3. Actions to follow up on the screening results. | Behavioural | Intervention group |
Primary outcome
Proportion of patients who are comprehensively screened to the number of eligible patients seen in the intervention group compared to the control group as assessed by the completeness of CV Screening Checklist data collection form.
Time frame: 6-8 weeks
If the CV screening Checklist is only partially completed or not completed at all then it will not be considered comprehensive. Logistic regression is used because the outcome is dichotomous (yes or no). The patients had comprehensive screening (Yes) or they did not have comprehensive screening (No).
3 secondary outcomes
Identification of individuals at high risk for cardiovascular disease as assessed by the calculated Framingham Risk Score.
Time frame: 6-8 weeks
The management recommendations that are made by the NPs as assessed by the responses collected on the CV Screening Checklist data collection form (intervention group) and the chart review (control group).
Time frame: 6-8 weeks
The patient and NP factors that influence participation in the CASP as assessed by content analysis of patient and NP feedback questionnaires.
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 25511466Alvarez-Bueno C, Cavero-Redondo I, Martinez-Andres M, Arias-Palencia N, Ramos-Blanes R, Salcedo-Aguilar F. Effectiveness of multifactorial interventions in primary health care settings for primary prevention of cardiovascular disease: A systematic review of systematic reviews. Prev Med. 2015 Jul;76 Suppl:S68-75. doi: 10.1016/j.ypmed.2014.11.028. Epub 2014 Dec 12.
- Background: PubMed 23701848Artac M, Dalton AR, Majeed A, Car J, Millett C. Effectiveness of a national cardiovascular disease risk assessment program (NHS Health Check): results after one year. Prev Med. 2013 Aug;57(2):129-34. doi: 10.1016/j.ypmed.2013.05.002. Epub 2013 May 21.
- Background: PubMed 26525065Avanzini F, Marzona I, Baviera M, Barlera S, Milani V, Caimi V, Longoni P, Tombesi M, Silletta MG, Tognoni G, Roncaglioni MC; Risk and Prevention Study Collaborative Group. Improving cardiovascular prevention in general practice: Results of a comprehensive personalized strategy in subjects at high risk. Eur J Prev Cardiol. 2016 Jun;23(9):947-55. doi: 10.1177/2047487315613664. Epub 2015 Nov 2.
- Background: PubMed 16621883Brindle P, Beswick A, Fahey T, Ebrahim S. Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review. Heart. 2006 Dec;92(12):1752-9. doi: 10.1136/hrt.2006.087932. Epub 2006 Apr 18.
- Background: PubMed 21459258Cardiometabolic Risk Working Group: Executive Committee; Leiter LA, Fitchett DH, Gilbert RE, Gupta M, Mancini GB, McFarlane PA, Ross R, Teoh H, Verma S, Anand S, Camelon K, Chow CM, Cox JL, Despres JP, Genest J, Harris SB, Lau DC, Lewanczuk R, Liu PP, Lonn EM, McPherson R, Poirier P, Qaadri S, Rabasa-Lhoret R, Rabkin SW, Sharma AM, Steele AW, Stone JA, Tardif JC, Tobe S, Ur E. Identification and management of cardiometabolic risk in Canada: a position paper by the cardiometabolic risk working group (executive summary). Can J Cardiol. 2011 Mar-Apr;27(2):124-31. doi: 10.1016/j.cjca.2011.01.016.
- Background: PubMed 25332362Tobe SW, Stone JA, Walker KM, Anderson T, Bhattacharyya O, Cheng AY, Gregoire J, Gubitz G, L'Abbe M, Lau DC, Leiter LA, Oh P, Padwal R, Poirier L, Selby P, Tremblay M, Ward RA, Hua D, Liu PP; C-CHANGE Initiative. Canadian Cardiovascular Harmonized National Guidelines Endeavour (C-CHANGE): 2014 update. CMAJ. 2014 Nov 18;186(17):1299-305. doi: 10.1503/cmaj.140387. Epub 2014 Oct 20. No abstract available.
- Derived from this study: PubMed 38789927Bruneau J, Moralejo D, Parsons K. Evaluating the effectiveness of the cardiovascular assessment screening program with nurse practitioners and patients: results of a cluster randomised controlled trial. BMC Prim Care. 2024 May 24;25(1):185. doi: 10.1186/s12875-024-02432-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Bruneau, PhD(c) principal investigator
Memorial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Assessment Screening Program (CASP) in people with Cardiovascular Risk Factor and Smoking, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are comprehensively screened to the number of eligible patients seen in the intervention group compared to the control group as assessed by the completeness of CV Screening Checklist data collection form. (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170752, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.