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Trial record 18 of 2721 for:    Rheumatoid Arthritis

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

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ClinicalTrials.gov Identifier: NCT03254745
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Atta Abbas Naqvi, University of Science Malaysia

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Pharmacist led pharmaceutical care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.
Primary Purpose: Health Services Research
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)
Actual Study Start Date : December 19, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacist intervention
  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
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.

No Intervention: Usual care
Patients will not be counseled by pharmacist and will be allowed to take usual care.



Primary Outcome Measures :
  1. Disease knowledge [ Time Frame: Week 12 from baseline ]
    Knowledge about rheumatoid arthritis

  2. Medication Adherence [ Time Frame: Week 12 from baseline ]
    Patients' adherence to their medications

  3. Health Related Quality of Life (HR-QOL) [ Time Frame: Week 12 from baseline ]
    Rheumatoid arthritis patients' health related quality of life

  4. Treatment Adherence [ Time Frame: Week 12 from baseline ]
    Patients' adherence to their rehabilitation

  5. Direct Cost [ Time Frame: Week 12 from baseline ]
    Direct cost of rheumatoid arthritis treatment on patient's pocket


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: At Week 12 ]
    Patient satisfaction from pharmacists in managing rheumatoid arthritis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254745


Locations
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Pakistan
Clifton Central Hospital
Karachi, Sindh, Pakistan, 75600
Sponsors and Collaborators
University of Science Malaysia
Investigators
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Study Director: Azmi A Hassali, PhD University of Science Malaysia

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Responsible Party: Atta Abbas Naqvi, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT03254745     History of Changes
Other Study ID Numbers: PACT1
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atta Abbas Naqvi, University of Science Malaysia:
Rheumatoid Arthritis
Pakistan
Pharmacist
Intervention
Treatment outcome

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases