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Pharmacist CVD Intervention for Patients With Inflammatory Arthritis (RxIALTA)

Primary Purpose

Inflammatory Arthritis, Cardiovascular Risk Factor, Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CV risk assessment and modification of global risk
Sponsored by
Epidemiology Coordinating and Research Centre, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Arthritis focused on measuring modifiable cardiovascular risk factors, cardiovascular risk factors, blood pressure, LDL-cholesterol, total-cholesterol, HDL-cholesterol, hemoglobin A1C, tobacco cessation, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • Calgary Co-operative Association LimitedRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with inflammatory arthritis

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in CV risk
CV risk re-assessment with validated RxEACH CV risk calculator

Secondary Outcome Measures

change in blood pressure
CV risk re-assessment with validated RxEACH CV risk calculator
change in LDL-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
change in total-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
change in HDL-cholesterol
CV risk re-assessment with validated RxEACH CV risk calculator
change in hemoglobin A1C
CV risk re-assessment with validated RxEACH CV risk calculator
tobacco cessation
CV risk re-assessment with validated RxEACH CV risk calculator

Full Information

First Posted
May 11, 2017
Last Updated
July 25, 2017
Sponsor
Epidemiology Coordinating and Research Centre, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03152396
Brief Title
Pharmacist CVD Intervention for Patients With Inflammatory Arthritis
Acronym
RxIALTA
Official Title
RxIALTA: Pharmacist CVD Intervention for Patients With Inflammatory Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Epidemiology Coordinating and Research Centre, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A non-randomized prospective pre-post-intervention design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with inflammatory arthritis
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CV risk assessment and modification of global risk
Other Intervention Name(s)
prescription adaptation, prescribing medications, ordering lab work (eg. A1C, lipid panel), interpreting lab work (eg. A1C, lipid panel), blood pressure measurement, height and weight measurements, waist circumference measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in CV risk
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in blood pressure
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Title
change in LDL-cholesterol
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Title
change in total-cholesterol
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Title
change in HDL-cholesterol
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Title
change in hemoglobin A1C
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months
Title
tobacco cessation
Description
CV risk re-assessment with validated RxEACH CV risk calculator
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea M Morgan, BScPharm
Phone
(403) 589-2576
Email
andrea.morgan@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ross Tsuyuki, MSc
Phone
(403) 994-8772
Email
rtsuyuki@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Tsuyuki, MSc
Organizational Affiliation
Epidemiology Coordinating and Research Centre, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary Co-operative Association Limited
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 1N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonal Ejner, BScPharm
Phone
(403) 219-6025
Ext
6123

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33762234
Citation
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.
Results Reference
derived

Learn more about this trial

Pharmacist CVD Intervention for Patients With Inflammatory Arthritis

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