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Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis: A Randomized Controlled Trial

Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis Patients in Karachi, Pakistan: The Pharmacist Assisted Care Trial for Rheumatoid Arthritis Patients (PACTRA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03254745
Acronym
PACTRA
Enrollment
400
Registered
2017-08-18
Start date
2017-12-19
Completion date
2018-08-17
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Pakistan, Pharmacist, Intervention, Treatment outcome

Brief summary

Rheumatoid arthritis is an auto-immune disorders that mainly affects the joints. It may also affect other organs of the body such as skin, eyes, lungs and heart. The immune system of the body attacks the lining of the joint that results in erosion and joint deformity. This condition if untreated may lead to disability. RA is managed by medications known as disease modifying anti rheumatic drugs (DMARDs) as well as physical therapy. Dietary and lifestyle modification may also ease the condition.

Detailed description

One of the major problems in managing RA is adherence to rehabilitation and medication. Studies report low adherence to medication among patients of RA. Certain barriers to rehabilitation also exists which may include exhaustive treatment attendance, time management and direct costs. Patient intentionally make decisions of non adherence to their prescribed rehabilitation schedule and medication regimen. This may be due to suffering from adverse drug reactions (ADRs) of medications, excessive pain arising from physical therapy and/or out-of-pocket costs. Pharmacists have the potential to improve the patient's clinical, humanistic and economic outcomes in rheumatoid arthritis by providing pharmaceutical care. This can be executed by: 1. Resolving drug related problems and managing drug therapy 2. Management of modifiable risk factors such as weight 3. Recommending dietary and lifestyle changes 4. Providing patient counseling, disease education and medication advice 5. Reducing the out-of-pocket costs 6. Improve overall well being and quality of life Evidence from the past indicates a varying prevalence of RA in Pakistan. Figures for prevalence of RA varied geographically as literature reported a prevalence of 0.142% to 5.5% in the southern and northern region of Pakistan respectively. Recently, a study conducted in a tertiary care unit in the city of Karachi located in southern region reported a figure of 633 (12.9%) for RA patients out of total 4900 patients who visited rheumatology clinic in the hospital. It highlighted that disease burden in this region has dramatically increased. Most Pakistani patients lack adequate disease knowledge and awareness regarding RA. Moreover, patients in Pakistan have to pay direct medical cost in most of the cases. In the past, studies have highlighted that Pakistani patients view costs per session and treatment attendance as major barriers to undergo physical therapy sessions for rheumatological disorders. There is a dearth of literature reported on pharmacist's inclusion to improve treatment outcomes in rheumatoid arthritis.There are no reported figures for adherence to treatment and medications for RA or any musculoskeletal disease. Studies conducted in Pakistan also highlight that pharmacists have the potential to improve economic, clinical and humanistic outcomes by providing pharmaceutical care to patients. However, it is to be seen if pharmacist can actually achieve the milestone i.e. improve patient treatment outcomes of rheumatoid arthritis. A randomized trial is therefore needed employing pharmacist intervention in RA patients. This present an excellent opportunity to identify the areas where a pharmacist has the potential to play his/her role and evaluate its effectiveness.

Interventions

OTHERPharmacist led pharmaceutical care

The intervention in the study will be a pharmacist's intervention that will be provided to rheumatoid arthritis patients in order to improve their treatment outcomes. It will be in the form of a single (1) session by pharmacist (face-to-face) followed by written material for use at home. The pharmacist will look at the patient's baseline data and provide counseling. The venue for counseling will be the hospitals.

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Out-patients with established diagnosis of rheumatoid arthritis over 3 months. * Participants who are willing to participate in the study.

Exclusion criteria

* Patients with no rheumatoid arthritis. * Patients currently undergoing surgery or had previous history of surgery. * Patients with more than 3 comorbidities. * Patients who are not willing to participate. * In-patients will not be included.

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsWeek 12 from baselineThe adverse events were assessed directly through patients' medical history that was available in hospital database.
Disease knowledgeWeek 12 from baselineKnowledge about rheumatoid arthritis
Medication AdherenceWeek 12 from baselinePatients' adherence to their medications
Health Related Quality of Life (HR-QOL)Week 12 from baselineRheumatoid arthritis patients' health related quality of life
Treatment AdherenceWeek 12 from baselinePatients' adherence to their rehabilitation
Direct Cost of treatmentWeek 12 from baselineDirect cost of rheumatoid arthritis treatment on patient's pocket
Disease ActivityWeek 12 from baselineThe disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.

Secondary

MeasureTime frameDescription
Patient satisfactionAt Week 12Patient satisfaction from pharmacists in managing rheumatoid arthritis

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026