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

NCT03254745 | Completed DMC

• 1 other identifier: PACT1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Pakistan; Pharmacist; Intervention; Treatment outcome

Outcome Measures

Primary Outcomes (7)

• Disease knowledge

  Knowledge about rheumatoid arthritis

  Week 12 from baseline

• Medication Adherence

  Patients' adherence to their medications

  Week 12 from baseline

• Health Related Quality of Life (HR-QOL)

  Rheumatoid arthritis patients' health related quality of life

  Week 12 from baseline

• Treatment Adherence

  Patients' adherence to their rehabilitation

  Week 12 from baseline

• Direct Cost of treatment

  Direct cost of rheumatoid arthritis treatment on patient's pocket

  Week 12 from baseline

• Disease Activity

  The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.

  Week 12 from baseline

• Adverse events

  The adverse events were assessed directly through patients' medical history that was available in hospital database.

  Week 12 from baseline

Secondary Outcomes (1)

• Patient satisfaction

  At Week 12

Study Arms (2)

Pharmacist intervention

EXPERIMENTAL

1. Disease education (General education about rheumatoid arthritis in a verbal and written manner) 2. Dietary and lifestyle modifications (General recommendations as well as specific ones based on patients' baseline health status) 3. Counseling regarding adherence (General lecture on adherence to medications and physical rehabilitation in rheumatoid arthritis as well as specific advice based on patients health status) 4. Advice on medication use (General counseling on medication use as well as patient centered counseling).

Other: Pharmacist led pharmaceutical care

Usual care

NO INTERVENTION

Patients will not be counseled by pharmacist and will be allowed to take usual care.

Interventions

Pharmacist led pharmaceutical care OTHER

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.

Pharmacist intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Clifton Central Hospital

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Azmi A Hassali, PhD

  Universiti Sains Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Atta Abbas Naqvi

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 18, 2017
• Study Start: December 19, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 17, 2018
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)