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

March 26, 2020 updated by: Atta Abbas Naqvi, Universiti Sains Malaysia

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Clifton Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease knowledge
Time Frame: Week 12 from baseline
Knowledge about rheumatoid arthritis
Week 12 from baseline
Medication Adherence
Time Frame: Week 12 from baseline
Patients' adherence to their medications
Week 12 from baseline
Health Related Quality of Life (HR-QOL)
Time Frame: Week 12 from baseline
Rheumatoid arthritis patients' health related quality of life
Week 12 from baseline
Treatment Adherence
Time Frame: Week 12 from baseline
Patients' adherence to their rehabilitation
Week 12 from baseline
Direct Cost of treatment
Time Frame: Week 12 from baseline
Direct cost of rheumatoid arthritis treatment on patient's pocket
Week 12 from baseline
Disease Activity
Time Frame: Week 12 from baseline
The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.
Week 12 from baseline
Adverse events
Time Frame: Week 12 from baseline
The adverse events were assessed directly through patients' medical history that was available in hospital database.
Week 12 from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: At Week 12
Patient satisfaction from pharmacists in managing rheumatoid arthritis
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Azmi A Hassali, PhD, Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PACT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Pharmacist led pharmaceutical care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings