Clinical trial NCT03254745: Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis: A Randomized Controlled Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Pakistan
Pharmacist
Intervention
Treatment outcome
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease knowledge
timeFrame: Week 12 from baseline
measure: Medication Adherence
timeFrame: Week 12 from baseline
measure: Health Related Quality of Life (HR-QOL)
timeFrame: Week 12 from baseline
measure: Treatment Adherence
timeFrame: Week 12 from baseline
measure: Direct Cost of treatment
timeFrame: Week 12 from baseline
measure: Disease Activity
timeFrame: Week 12 from baseline
measure: Adverse events
timeFrame: Week 12 from baseline
Secondary outcomes:
measure: Patient satisfaction
timeFrame: At Week 12
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Clifton Central Hospital
state: Sindh
Study officials:
affiliation: Universiti Sains Malaysia
name: Azmi A Hassali, PhD
role: STUDY_DIRECTOR
References: