AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Andrea M Morgan, BScPharm contact

(403) 589-2576

andrea.morgan@ahs.ca

Ross Tsuyuki, MSc contact

(403) 994-8772

rtsuyuki@ualberta.ca

Canada1 site, 1 recruiting
  • Calgary Co-operative Association Limited

    Calgary, Alberta, T2H 1N6

    Sonal Ejner, BScPharm, (403) 219-6025 ext. 6123

    Recruiting

Other trials in Canada

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

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 groups in NCT03152396
Study groupRoleWhat they receive
Patients with inflammatory arthritisOtherAll 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.

  1. Change in CV risk

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

Secondary outcomes (6)
  1. change in blood pressure

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

  2. change in LDL-cholesterol

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

  3. change in total-cholesterol

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

  4. change in HDL-cholesterol

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

  5. change in hemoglobin A1C

    CV risk re-assessment with validated RxEACH CV risk calculator

    Measured: 6 months

  6. 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.

  1. First posted15 May 2017
  2. Study start17 Jul 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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)
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

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.

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