Rheumatoid ArthritisPACTRANCT03254745
Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis: A Randomized Controlled Trial
A study testing Pharmacist led pharmaceutical care in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Pharmacist led pharmaceutical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Dec 2017to 17 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
- Participants who are willing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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:
- Resolving drug related problems and managing drug therapy
- Management of modifiable risk factors such as weight
- Recommending dietary and lifestyle changes
- Providing patient counseling, disease education and medication advice
- Reducing the out-of-pocket costs
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Pharmacist led pharmaceutical care
- Keywords
- Rheumatoid Arthritis, Pakistan, Pharmacist, Intervention, Treatment outcome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist led pharmaceutical careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Pharmacist led pharmaceutical care |
| Usual care | No intervention | Patients will not be counseled by pharmacist and will be allowed to take usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease knowledge
Knowledge about rheumatoid arthritis
Measured: Week 12 from baseline
Medication Adherence
Patients' adherence to their medications
Measured: Week 12 from baseline
Health Related Quality of Life (HR-QOL)
Rheumatoid arthritis patients' health related quality of life
Measured: Week 12 from baseline
Treatment Adherence
Patients' adherence to their rehabilitation
Measured: Week 12 from baseline
Direct Cost of treatment
Direct cost of rheumatoid arthritis treatment on patient's pocket
Measured: Week 12 from baseline
Disease Activity
The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.
Measured: Week 12 from baseline
Adverse events
The adverse events were assessed directly through patients' medical history that was available in hospital database.
Measured: Week 12 from baseline
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction from pharmacists in managing rheumatoid arthritis
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start19 Dec 2017
- Primary completion1 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atta Abbas Naqvi, Universiti Sains Malaysia
- Investigators
- Azmi A Hassali, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254745
- Sponsor's protocol ID
- PACT1
- Acronym
- PACTRA
- Status last verified
- Mar 2020
- First submitted
- 15 Aug 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03254745
- Acronym / sponsor ID
- PACTRA / PACT1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Pakistan, Pharmacist, Intervention, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Resolving drug related problems and managing drug therapy
- Management of modifiable risk factors such as weight
- Recommending dietary and lifestyle changes
- Providing patient counseling, disease education and medication advice
- Reducing the out-of-pocket costs
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist intervention | Experimental | Other: Pharmacist led pharmaceutical care1. 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). |
| Usual care | No intervention | –Patients will not be counseled by pharmacist and will be allowed to take usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Out-patients with established diagnosis of rheumatoid arthritis over 3 months.
- Participants who are willing to participate in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist led pharmaceutical careThe 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. | Other | Pharmacist intervention |
Primary outcome
Disease knowledge
Time frame: Week 12 from baseline
Knowledge about rheumatoid arthritis
Medication Adherence
Time frame: Week 12 from baseline
Patients' adherence to their medications
Health Related Quality of Life (HR-QOL)
Time frame: Week 12 from baseline
Rheumatoid arthritis patients' health related quality of life
Treatment Adherence
Time frame: Week 12 from baseline
Patients' adherence to their rehabilitation
Direct Cost of treatment
Time frame: Week 12 from baseline
Direct cost of rheumatoid arthritis treatment on patient's pocket
Disease Activity
Time frame: Week 12 from baseline
The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.
Adverse events
Time frame: Week 12 from baseline
The adverse events were assessed directly through patients' medical history that was available in hospital database.
1 secondary outcome
Patient satisfaction
Time frame: At Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azmi A Hassali, PhD study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist led pharmaceutical care in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease knowledge (time frame: Week 12 from baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.