Inflammatory ArthritisRxIALTANCT03152396
Pharmacist CVD Intervention for Patients With Inflammatory Arthritis
A study testing CV risk assessment and modification of global risk in people with Inflammatory Arthritis and Cardiovascular Risk Factor, run by Epidemiology Coordinating and Research Centre, Canada at 1 site in Canada.
Trial summary
Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading causes of death and disability in Canada today. The majority of CVD cases are caused by factors that can be controlled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Cardiovascular Risk Factor, Rheumatoid Arthritis
- What is being tested?
- CV risk assessment and modification of global risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2017to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age) who have a physician-diagnosed IA including
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- To be eligible for inclusion, all patients must have at least one uncontrolled risk factor (i.e., blood pressure, LDL-cholesterol, HbA1c, or current tobacco use)
Who cannot join
- Patients will be excluded if they
- Are unwilling to participate/sign consent form
- Are unwilling or unable to participate in regular follow-up visits
- Are pregnant
- Have uncontrolled IA (i.e., during a disease exacerbation)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Calgary Co-operative Association Limited
Calgary, Alberta, T2H 1N6
Sonal Ejner, BScPharm, (403) 219-6025 ext. 6123
About this study
Official title: RxIALTA: Pharmacist CVD Intervention for Patients With Inflammatory Arthritis
Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading causes of death and disability in Canada today. The majority of CVD cases are caused by factors that can be controlled. These factors include tobacco use, obesity, high blood pressure, high cholesterol, diabetes, and physical inactivity. Such factors are common and not well controlled. Inflammatory arthritis (IA) (Inflammation of the joints and other tissues) is considered another risk factor or CVD. As such, people who have IA and any of the previously mentioned risk factors would be at high risk for developing CVD. Controlling these factors will bring down the risk of having cardiovascular disease and make the quality of the individuals' life better. Pharmacists work with patients and their family doctors to provide cardiovascular care. Having a pharmacist involved in the care process may help patients with IA reduce their CV risk. Pharmacists are easier to reach and may have more opportunities to educate people about medications. This might lead to better prevention and control of cardiovascular diseases.
Read the detailed description
Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality worldwide and in Canada accounting for nearly one third of the total deaths in both instances.1-2 The majority of CVD cases are caused by modifiable risk factors such as tobacco use, obesity, hypertension, hyperlipidemia, diabetes and physical inactivity.3 Inflammatory arthritis, inclusive of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), is also recognized as an independent risk factor for CVD.4-7
It has been reported that the risk of myocardial infarction (MI), heart failure (HF) and CV death among patients with IA is 2-3-fold greater than in the general population.8-10 This increased CV risk reflects the combined impact of systemic inflammation, burden of traditional CVD risk factors and impact of certain medications (e.g. steroids, non-steroidal anti-inflammatories [NSAIDs]).5,6 An elevated risk of CVD can be identified early after IA diagnosis, emphasizing the need for early efforts in CV risk screening.11
Despite being recommended by international IA management guidelines,7 CV risk assessment has not been incorporated into clinicians' daily routine.7 Indeed, it has been reported that such assessments generally only exist in larger centers for non-rheumatology patients.12-14 Moreover, Keeling and colleagues reported that most rheumatologists, who are the main care givers for IA patients, conducted suboptimal CV risk assessments. 15 This gap in care for patients with IA is not consistently absorbed by family physicians due to lack of recognition of CV risk in these patients and competing demands of other healthcare needs (e.g. other chronic diseases, cancer, diabetes). 7
Special considerations need to be taken into account when calculating CV risk in patients with IA, as the 'classic' risk engines (such as Framingham16) might underestimate the overall risk,17 since they have not been adequately evaluated in this patient population.18,5 For example, IA patients who might benefit from lipid-lowering agents may be categorized "low risk" when using the Framingham risk engine.17 As such it has been recommended to use a modified Framingham risk engine (multiply the overall risk with 1.5) in patients with IA. 19
CV risk screening and management in patients with IA takes time and effort, but can be performed by other trained health professionals. As such, it has been recommended to utilize a multidisciplinary approach (integration of rheumatology, cardiology and primary care) to support the care of IA patients.6,20-23 Pharmacists are front line, accessible, primary healthcare professionals who see patients more frequently than any other healthcare provider.24 The efficacy of their interventions in managing chronic diseases including osteoarthritis,25, diabetes,7, 26 dyslipidemia,27 hypertension,28,29 heart failure,30 and CVD 31-34 has been well demonstrated in the literature. Pharmacists can systematically identify patients at high risk of CVD,35 improve their medication use,36 and help them achieve their treatment targets.27,28 In addition to clinical outcomes, pharmacist involvement in patient care is associated with improved patient satisfaction and adherence to therapy.28,35,36 This evidence, coupled with their advanced scope of practice, ideally position pharmacists to conduct CV risk screening and management. In addition, Canadian pharmacists have access to practice guidelines for management and prevention of cardiovascular disease in the general population.37 They also have access to the RxEACH CV risk calculator, an interactive CV screening and management tool, which will help them determine CV risk, simply communicate contributing risks to patients, and show patients the impact of modifying their risks. 34
- Conditions
- Inflammatory Arthritis, Cardiovascular Risk Factor, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Being tested
- CV risk assessment and modification of global risk
- Keywords
- modifiable cardiovascular risk factors, cardiovascular risk factors, blood pressure, LDL-cholesterol, total-cholesterol, HDL-cholesterol, hemoglobin A1C, tobacco cessation, patient satisfaction
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Tobacco Use Cessation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV risk assessment and modification of global riskOther
Also called prescription adaptation, prescribing medications, ordering lab work (eg. A1C, lipid panel), interpreting lab work (eg. A1C, lipid panel)
Individualized CV risk assessment using the validated RxEACH CV risk calculator for baseline and subsequent risk assessment. Pharmacists will assist patient's to decrease CV risk over 6 months thru education, medication modification, and monthly follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Patients with inflammatory arthritis | Other | All patients enrolled have a form of inflammatory arthritis and at least one uncontrolled CV risk factor (i.e. blood pressure, LDL-cholesterol, HbA1C, or current tobacco use). Pharmacist will assess each participants CV risk score using the validated RxEACH CV risk calculator. Over the 6 month intervention period, pharmacists will assist patients to modify a contributing risk factor thru treatment recommendations, prescription adaptation, and prescribing where necessary to meet treatment targets. Receives: Other: CV risk assessment and modification of global risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CV risk
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
Secondary outcomes (6)
change in blood pressure
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
change in LDL-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
change in total-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
change in HDL-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
change in hemoglobin A1C
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
tobacco cessation
CV risk re-assessment with validated RxEACH CV risk calculator
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start17 Jul 2017
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ArthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A non-randomized prospective pre-post-intervention design.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epidemiology Coordinating and Research Centre, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morgan, Epidemiology Coordinating and Research Centre, Canada
- Investigators
- Ross Tsuyuki, MSc, Principal investigator, Epidemiology Coordinating and Research Centre, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152396
- Sponsor's protocol ID
- Pro00072858
- Acronym
- RxIALTA
- Status last verified
- Jul 2017
- First submitted
- 11 May 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Hamarneh YN, Marra C, Gniadecki R, Keeling S, Morgan A, Tsuyuki R. RxIALTA: evaluating the effect of a pharmacist-led intervention on CV risk in patients with chronic inflammatory diseases in a community pharmacy setting: a prospective pre-post intervention study. BMJ Open. 2021 Mar 24;11(3):e043612. doi: 10.1136/bmjopen-2020-043612.
PubMed 33762234
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RxIALTA: Pharmacist CVD Intervention for Patients With Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT03152396
- Acronym / sponsor ID
- RxIALTA / Pro00072858
- Conditions
- Inflammatory Arthritis, Cardiovascular Risk Factor, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Keywords
- modifiable cardiovascular risk factors, cardiovascular risk factors, blood pressure, LDL-cholesterol, total-cholesterol, HDL-cholesterol, hemoglobin A1C, tobacco cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Epidemiology Coordinating and Research Centre, CanadaUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 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.
Cardiovascular disease (CVD) (disease of the heart and blood vessels) is one of the leading causes of death and disability in Canada today. The majority of CVD cases are caused by factors that can be controlled. These factors include tobacco use, obesity, high blood pressure, high cholesterol, diabetes, and physical inactivity. Such factors are common and not well controlled. Inflammatory arthritis (IA) (Inflammation of the joints and other tissues) is considered another risk factor or CVD. As such, people who have IA and any of the previously mentioned risk factors would be at high risk for developing CVD. Controlling these factors will bring down the risk of having cardiovascular disease and make the quality of the individuals' life better. Pharmacists work with patients and their family doctors to provide cardiovascular care. Having a pharmacist involved in the care process may help patients with IA reduce their CV risk. Pharmacists are easier to reach and may have more opportunities to educate people about medications. This might lead to better prevention and control of cardiovascular diseases.
Detailed description
Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality worldwide and in Canada accounting for nearly one third of the total deaths in both instances.1-2 The majority of CVD cases are caused by modifiable risk factors such as tobacco use, obesity, hypertension, hyperlipidemia, diabetes and physical inactivity.3 Inflammatory arthritis, inclusive of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), is also recognized as an independent risk factor for CVD.4-7
It has been reported that the risk of myocardial infarction (MI), heart failure (HF) and CV death among patients with IA is 2-3-fold greater than in the general population.8-10 This increased CV risk reflects the combined impact of systemic inflammation, burden of traditional CVD risk factors and impact of certain medications (e.g. steroids, non-steroidal anti-inflammatories [NSAIDs]).5,6 An elevated risk of CVD can be identified early after IA diagnosis, emphasizing the need for early efforts in CV risk screening.11
Despite being recommended by international IA management guidelines,7 CV risk assessment has not been incorporated into clinicians' daily routine.7 Indeed, it has been reported that such assessments generally only exist in larger centers for non-rheumatology patients.12-14 Moreover, Keeling and colleagues reported that most rheumatologists, who are the main care givers for IA patients, conducted suboptimal CV risk assessments. 15 This gap in care for patients with IA is not consistently absorbed by family physicians due to lack of recognition of CV risk in these patients and competing demands of other healthcare needs (e.g. other chronic diseases, cancer, diabetes). 7
Special considerations need to be taken into account when calculating CV risk in patients with IA, as the 'classic' risk engines (such as Framingham16) might underestimate the overall risk,17 since they have not been adequately evaluated in this patient population.18,5 For example, IA patients who might benefit from lipid-lowering agents may be categorized "low risk" when using the Framingham risk engine.17 As such it has been recommended to use a modified Framingham risk engine (multiply the overall risk with 1.5) in patients with IA. 19
CV risk screening and management in patients with IA takes time and effort, but can be performed by other trained health professionals. As such, it has been recommended to utilize a multidisciplinary approach (integration of rheumatology, cardiology and primary care) to support the care of IA patients.6,20-23 Pharmacists are front line, accessible, primary healthcare professionals who see patients more frequently than any other healthcare provider.24 The efficacy of their interventions in managing chronic diseases including osteoarthritis,25, diabetes,7, 26 dyslipidemia,27 hypertension,28,29 heart failure,30 and CVD 31-34 has been well demonstrated in the literature. Pharmacists can systematically identify patients at high risk of CVD,35 improve their medication use,36 and help them achieve their treatment targets.27,28 In addition to clinical outcomes, pharmacist involvement in patient care is associated with improved patient satisfaction and adherence to therapy.28,35,36 This evidence, coupled with their advanced scope of practice, ideally position pharmacists to conduct CV risk screening and management. In addition, Canadian pharmacists have access to practice guidelines for management and prevention of cardiovascular disease in the general population.37 They also have access to the RxEACH CV risk calculator, an interactive CV screening and management tool, which will help them determine CV risk, simply communicate contributing risks to patients, and show patients the impact of modifying their risks. 34
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-randomized prospective pre-post-intervention design.
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory arthritis | Other | Other: CV risk assessment and modification of global riskAll patients enrolled have a form of inflammatory arthritis and at least one uncontrolled CV risk factor (i.e. blood pressure, LDL-cholesterol, HbA1C, or current tobacco use). Pharmacist will assess each participants CV risk score using the validated RxEACH CV risk calculator. Over the 6 month intervention period, pharmacists will assist patients to modify a contributing risk factor thru treatment recommendations, prescription adaptation, and prescribing where necessary to meet treatment targets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years of age) who have a physician-diagnosed IA including
Key exclusion criteria (5 listed)
- Patients will be excluded if they
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 |
|---|---|---|
| CV risk assessment and modification of global riskAlso: prescription adaptation, prescribing medications, ordering lab work (eg. A1C, lipid panel), interpreting lab work (eg. A1C, lipid panel)Individualized CV risk assessment using the validated RxEACH CV risk calculator for baseline and subsequent risk assessment. Pharmacists will assist patient's to decrease CV risk over 6 months thru education, medication modification, and monthly follow-up. | Other | Patients with inflammatory arthritis |
Primary outcome
Change in CV risk
Time frame: 6 months
CV risk re-assessment with validated RxEACH CV risk calculator
6 secondary outcomes
change in blood pressure
Time frame: 6 months
change in LDL-cholesterol
Time frame: 6 months
change in total-cholesterol
Time frame: 6 months
change in HDL-cholesterol
Time frame: 6 months
change in hemoglobin A1C
Time frame: 6 months
tobacco cessation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Derived from this study: PubMed 33762234Al Hamarneh YN, Marra C, Gniadecki R, Keeling S, Morgan A, Tsuyuki R. RxIALTA: evaluating the effect of a pharmacist-led intervention on CV risk in patients with chronic inflammatory diseases in a community pharmacy setting: a prospective pre-post intervention study. BMJ Open. 2021 Mar 24;11(3):e043612. doi: 10.1136/bmjopen-2020-043612.
- 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.
Ross Tsuyuki, MSc principal investigator
Epidemiology Coordinating and Research Centre, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CV risk assessment and modification of global risk in people with Inflammatory Arthritis and Cardiovascular Risk Factor, run by Epidemiology Coordinating and Research Centre, Canada 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea M Morgan, BScPharm ((403) 589-2576, andrea.morgan@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CV risk (time frame: 6 months). 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 NCT03152396, which also lists 1 linked publication.
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 27 Jul 2017.