Recruiting

CVD Intervention

Sponsor:

Epidemiology Coordinating and Research Centre, Canada

Code:

NCT03152396

Conditions

Inflammatory Arthritis

Cardiovascular Risk Factor

Rheumatoid Arthritis

Ankylosing Spondylitis

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CV risk assessment and modification of global risk

Study Details

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.

Conditions

Inflammatory Arthritis

Cardiovascular Risk Factor

Rheumatoid Arthritis

Ankylosing Spondylitis

Psoriatic Arthritis

Study ID

NCT03152396

Start date

Jul 17, 2017

Status verified date

Jul, 2017

Completion date

Sep, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Patients with inflammatory arthritis

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.

Interventions

CV risk assessment and modification of global risk

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

  • Change in CV risk [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Andrea M Morgan, BScPharm

(403) 589-2576andrea.morgan@ahs.ca

Ross Tsuyuki, MSc

(403) 994-8772rtsuyuki@ualberta.ca

Locations

Calgary Co-operative Association Limited

Recruiting

Calgary, Alberta, Canada, T2H 1N6

Contacts

Sonal Ejner, BScPharm

(403) 219-6025

More Information

Sponsor

Epidemiology Coordinating and Research Centre, Canada

Last update posted

Jul 27, 2017

Last verified

Jul, 2017

Keywords

  • modifiable cardiovascular risk factors
  • cardiovascular risk factors
  • blood pressure
  • LDL-cholesterol
  • total-cholesterol
  • HDL-cholesterol
  • hemoglobin A1C
  • tobacco cessation
  • patient satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Epidemiology Coordinating and Research Centre, Canada on 2017-07-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.