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

Rheumatoid Arthritis Clinical Trial

— PACTRA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254745
• Other study ID #: PACT1
• Status: Completed
• Phase: N/A
• Start date: December 19, 2017
• Est. completion date: August 17, 2018

Study information

• Verified date: March 2020
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 17, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Pharmacist 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.

Locations

Country	Name	City	State
Pakistan	Clifton Central Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease knowledge	Knowledge about rheumatoid arthritis	Week 12 from baseline
Primary	Medication Adherence	Patients' adherence to their medications	Week 12 from baseline
Primary	Health Related Quality of Life (HR-QOL)	Rheumatoid arthritis patients' health related quality of life	Week 12 from baseline
Primary	Treatment Adherence	Patients' adherence to their rehabilitation	Week 12 from baseline
Primary	Direct Cost of treatment	Direct cost of rheumatoid arthritis treatment on patient's pocket	Week 12 from baseline
Primary	Disease Activity	The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.	Week 12 from baseline
Primary	Adverse events	The adverse events were assessed directly through patients' medical history that was available in hospital database.	Week 12 from baseline
Secondary	Patient satisfaction	Patient satisfaction from pharmacists in managing rheumatoid arthritis	At Week 12