Pharmacist CVD Intervention for Patients With Inflammatory Arthritis

NCT03152396 | Unknown

• 1 other identifier: Pro00072858
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in CV risk

  CV risk re-assessment with validated RxEACH CV risk calculator

  6 months

Secondary Outcomes (6)

• change in blood pressure

  6 months

• change in LDL-cholesterol

  6 months

• change in total-cholesterol

  6 months

• change in HDL-cholesterol

  6 months

• change in hemoglobin A1C

  6 months

Study Arms (1)

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.

Other: CV risk assessment and modification of global risk

Interventions

CV risk assessment and modification of global risk OTHER

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.

Also known as: 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

Patients with inflammatory arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years of age) who have a physician-diagnosed IA including
• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Epidemiology Coordinating and Research Centre, Canada: lead

Study Sites (1)

Calgary Co-operative Association Limited

Calgary, Alberta, T2H 1N6, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33762234 DERIVED

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Tobacco Use Cessation; Patient Satisfaction

Interventions

Body Height

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Health Behavior; Behavior; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development

Study Officials

• Ross Tsuyuki, MSc

  Epidemiology Coordinating and Research Centre, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea M Morgan, BScPharm

CONTACT

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

Ross Tsuyuki, MSc

CONTACT

(403) 994-8772; rtsuyuki@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: A non-randomized prospective pre-post-intervention design.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: July 17, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)