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Published in: Trials 1/2019

Open Access 01-12-2019 | Rheumatoid Arthritis | Study protocol

Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial

Authors: Atta Abbas Naqvi, Mohamed Azmi Hassali, Syed Baqir Shyum Naqvi, Muhammad Tariq Aftab

Published in: Trials | Issue 1/2019

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Abstract

Background

The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatment. The study also documents patient satisfaction with pharmacist counselling as a quality control measure.

Methods/design

This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.

Discussion

This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.

Trial registration

ClinicalTrials.gov, NCT03827148. Registered on February 2019.
Appendix
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Metadata
Title
Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial
Authors
Atta Abbas Naqvi
Mohamed Azmi Hassali
Syed Baqir Shyum Naqvi
Muhammad Tariq Aftab
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3540-z

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