Rheumatoid ArthritisDRAMATICNCT03827148
Impact of Pharmacist Intervention on Disease Knowledge, Rehabilitation and Medication Adherence, Treatment Induced Direct Cost, Health-related Quality of Life and Satisfaction in Patients With Rheumatoid Arthritis
A study testing Pharmaceutical Care in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 1 site in Pakistan.
Trial summary
The objective of this study was to evaluate effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health related quality of life and direct cost of treatment. The study also documented patient satisfaction with pharmacist counselling as a quality control measure. 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?
- Pharmaceutical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Nov 2018to 1 Jul 2019
- 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
None listed.
Who cannot join
- Patients were excluded from the study if they had any of the following conditions:
- Patients with musculoskeletal illnesses other than rheumatoid arthritis
- Patients with a recent history of surgery or planned surgery for rheumatoid arthritis
- Patients with more than three co-morbidities
- Patients with any lab abnormalities, being treated for liver or kidney disease
- Patients who have had a severe infection and have completed antibiotic course in the last week
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- Patients with advanced cardiovascular disease, severe allergies or a rare disease
- Patients who are currently participating in other clinical trial or have participated in the last three months.
- Pregnant patients, planning to become pregnant, breast feeding and females with other gynecological issues were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pharmacist Intervention on Disease Knowledge, Rehabilitation and Medication Adherence, Treatment Induced Direct Cost, Health-related Quality of Life and Satisfaction in Patients With Rheumatoid Arthritis: a Randomized Single-blind Two-arm Controlled Trial
The objective of this study was to evaluate effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health related quality of life and direct cost of treatment. The study also documented patient satisfaction with pharmacist counselling as a quality control measure.
This is a randomized controlled single-blind two-arm trial in patients with rheumatoid arthritis in Karachi, Pakistan. The study will enroll patients with established diagnosis of rheumatoid arthritis over three months. The patients after signing written consent would be randomized through a computer-generated list in control group, i.e., usual care and intervention group, i.e., pharmaceutical care with a ratio of 1:1. The study will take place in three patient-visits over the course of three months. The patients would be intervened by pharmacist in intervention group while those in control group will have usual care. Primary outcomes include change in mean score at follow-up, i.e., week 12, for disease knowledge, adherence to medications and rehabilitation/physical therapy, health related quality of life (HRQoL). The secondary outcomes include change in the mean direct cost of treatment and patient satisfaction from pharmacist counselling.
This is a novel study that evaluates the role of pharmacist in improving treatment outcomes of patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for such patients in Pakistan. The results of this trial would be published in a peer-reviewed journal.
Read the detailed description
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joints and results in pain, swelling and decreased mobility. The disease over the course of time, leads to joint deformity and disability. The disease ranks third as major cause of disability after osteoarthritis and gout and affects roughly 1% of global population. Decrease mobility in patients results in decreased productivity and further worsens their quality of life. While pharmacological treatment may be essential in managing the acute flares and episodic pain associated with the disease, self-care and home-based management of RA is another important area of care which patients need to incorporate to manage it effectively.
Several studies have reported that self-care in RA effectively reduces acute flares. This could be done through the use of patient education and counselling. Pharmacist provide pharmaceutical care that incorporates these areas of care. Pharmaceutical care is an individualized patient-centric health service delivered by pharmacists that incorporates, but is not limited to, disease education, therapy management, self-care and self-management of disease and therapy as well as motivational guidance.
Evidence from several randomized trials indicate that patient counselling, disease education and telephonic interventions have improved self-care practices of patients. Educating patients about managing RA empowers them in understanding signs and symptoms of disease and devise ways to reduce or limit aggravating factors. A randomized trial conducted by Petkova that involved community pharmacy-based patient education program improved treatment outcomes of arthritis patients. Moreover, Mary and colleagues demonstrated positive effect of mobile phone short message service on medication adherence of patients with RA.
In the last decade there has been only few studies that have evaluated the impact of pharmacist-led pharmaceutical care on treatment outcomes in patients with rheumatoid arthritis. In Pakistan, no study has been conducted till date that evaluates the same. Since, the disease prevalence has increased in Pakistani population of late, and mainly affects the middle-aged individuals, it is expected to affect their productivity, employ-ability and income. This would worsen their health-related quality of life and adds to economic burden of this disease on the society. Therefore, a need was felt to evaluate the impact of pharmacist-delivered pharmaceutical care on treatment outcomes in Pakistani patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Pharmaceutical Care
- Keywords
- Pharmacist intervention, Disease knowledge, Medication adherence, Rehabilitation, Physical therapy, Health related quality of life, Direct cost of treatment, Rheumatoid arthritis, Pakistan, Out-patients
- Medical subject headings
- Arthritis, Rheumatoid, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical CareOther
Pharmaceutical care is an individualized patient-centric health service delivered by pharmacists that incorporates, but is not limited to, disease education, therapy management, self-care and self-management of disease and therapy as well as motivational guidance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Pharmacist-delivered pharmaceutical care | Experimental | The intervention consist of a pharmacist providing pharmaceutical care with aim to improve the treatment outcomes. It will be in the form of a single face-to-face session by pharmacist. Moreover, a specially designed rheumatoid arthritis disease education literature will be provided in both Urdu and English languages to patients for home use. The patients will be provided a contact number at which the pharmacist will be available at all times for the next three months (week 12). A specially designated counselling area in the pharmacy department of the hospitals served as venues for intervention. Receives: Other: Pharmaceutical Care |
| Control: Usual Care | No intervention | The patient in control group will have usual care without pharmacist intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid arthritis disease knowledge
Patient knowledge regarding rheumatoid arthritis will be assessed after three months (week 12) from baseline (week 0). The Rheumatoid Knowledge Assessment Scale (RAKAS) will be used to measure rheumatoid arthritis disease knowledge. The RAKAS is a thirteen-item scale that contains questions related to knowledge, symptoms, treatment and risk factors. The items are multiple choice questions (MCQs) and correct answer awards a score while the wrong answers provides no score. A cumulative score is calculated which is interpreted as excellent, good, low and poor knowledge.
Measured: 3 months
Treatment adherence
Patient adherence to rehabilitation/physical therapy after three months (week 12) from baseline (week 0). The assessment of adherence to rehabilitation/physical therapy, will be done through Urdu version of General Rehabilitation Adherence Scale (GRAS).
Measured: 3 months
Medication adherence
Patient adherence to medication therapy after three months (week 12) from baseline (week 0). For the assessment of adherence to medication and pharmacotherapy, the Urdu version of General Medication Adherence Scale (GMAS) will be used.
Measured: 3 months
Health related quality of life (HRQoL)
It will be assessed after three months (week 12) from baseline (week 0).The EQ-5D-5L is a generic tool to measure health and provides a numeric value for health status of patient. The score is then calculated as per the criteria specified by the EuroQol.
Measured: 3 months
Secondary outcomes (2)
Direct cost of treatment
The mean direct cost of rheumatoid arthritis treatment after three months (week 12) from baseline (week 0) in patients enrolled in control (CG) and intervention groups (IG).
Measured: 3 months
Patient satisfaction
Patient satisfaction resulting from pharmacist-led pharmaceutical care. The proportion (%) of patients in the intervention group (IG) who were satisfied with the intervention after three months (week 12) from baseline (week 0).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start17 Nov 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- This study is a randomized single-blind parallel trial. The patients who participate in this study after signing of consent would be randomly assigned to either control group (CG), i.e., usual care or intervention group (IG), i.e., pharmaceutical care. The allocation ratio will be 1:1. The participants in the intervention group would be counselled by pharmacist, provided a disease education literature and would have access to pharmacist for 90 days via telephone. The participants in the control group would received usual care without pharmacist intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Clifton Central Hospital
- Responsible party
- Principal investigator, Atta Abbas Naqvi, Universiti Sains Malaysia
- Investigators
- Mohamed A Hassali, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827148
- Sponsor's protocol ID
- USM
- Acronym
- DRAMATIC
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naqvi AA, Hassali MA, Naqvi SBS, Aftab MT. Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2019 Aug 9;20(1):488. doi: 10.1186/s13063-019-3540-z.
PubMed 31399128
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmacist Intervention on Disease Knowledge, Rehabilitation and Medication Adherence, Treatment Induced Direct Cost, Health-related Quality of Life and Satisfaction in Patients With Rheumatoid Arthritis: a Randomized Single-blind Two-arm Controlled Trial
- ClinicalTrials.gov ID
- NCT03827148
- Acronym / sponsor ID
- DRAMATIC / USM
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pharmacist intervention, Disease knowledge, Medication adherence, Rehabilitation, Physical therapy, Health related quality of life, Direct cost of treatment, Rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Clifton Central Hospital
- Study start
- 17 Nov 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 1 Feb 2019 (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.
The objective of this study was to evaluate effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health related quality of life and direct cost of treatment. The study also documented patient satisfaction with pharmacist counselling as a quality control measure.
This is a randomized controlled single-blind two-arm trial in patients with rheumatoid arthritis in Karachi, Pakistan. The study will enroll patients with established diagnosis of rheumatoid arthritis over three months. The patients after signing written consent would be randomized through a computer-generated list in control group, i.e., usual care and intervention group, i.e., pharmaceutical care with a ratio of 1:1. The study will take place in three patient-visits over the course of three months. The patients would be intervened by pharmacist in intervention group while those in control group will have usual care. Primary outcomes include change in mean score at follow-up, i.e., week 12, for disease knowledge, adherence to medications and rehabilitation/physical therapy, health related quality of life (HRQoL). The secondary outcomes include change in the mean direct cost of treatment and patient satisfaction from pharmacist counselling.
This is a novel study that evaluates the role of pharmacist in improving treatment outcomes of patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for such patients in Pakistan. The results of this trial would be published in a peer-reviewed journal.
Detailed description
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joints and results in pain, swelling and decreased mobility. The disease over the course of time, leads to joint deformity and disability. The disease ranks third as major cause of disability after osteoarthritis and gout and affects roughly 1% of global population. Decrease mobility in patients results in decreased productivity and further worsens their quality of life. While pharmacological treatment may be essential in managing the acute flares and episodic pain associated with the disease, self-care and home-based management of RA is another important area of care which patients need to incorporate to manage it effectively.
Several studies have reported that self-care in RA effectively reduces acute flares. This could be done through the use of patient education and counselling. Pharmacist provide pharmaceutical care that incorporates these areas of care. Pharmaceutical care is an individualized patient-centric health service delivered by pharmacists that incorporates, but is not limited to, disease education, therapy management, self-care and self-management of disease and therapy as well as motivational guidance.
Evidence from several randomized trials indicate that patient counselling, disease education and telephonic interventions have improved self-care practices of patients. Educating patients about managing RA empowers them in understanding signs and symptoms of disease and devise ways to reduce or limit aggravating factors. A randomized trial conducted by Petkova that involved community pharmacy-based patient education program improved treatment outcomes of arthritis patients. Moreover, Mary and colleagues demonstrated positive effect of mobile phone short message service on medication adherence of patients with RA.
In the last decade there has been only few studies that have evaluated the impact of pharmacist-led pharmaceutical care on treatment outcomes in patients with rheumatoid arthritis. In Pakistan, no study has been conducted till date that evaluates the same. Since, the disease prevalence has increased in Pakistani population of late, and mainly affects the middle-aged individuals, it is expected to affect their productivity, employ-ability and income. This would worsen their health-related quality of life and adds to economic burden of this disease on the society. Therefore, a need was felt to evaluate the impact of pharmacist-delivered pharmaceutical care on treatment outcomes in Pakistani patients with rheumatoid arthritis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized single-blind parallel trial. The patients who participate in this study after signing of consent would be randomly assigned to either control group (CG), i.e., usual care or intervention group (IG), i.e., pharmaceutical care. The allocation ratio will be 1:1. The participants in the intervention group would be counselled by pharmacist, provided a disease education literature and would have access to pharmacist for 90 days via telephone. The participants in the control group would received usual care without pharmacist intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Pharmacist-delivered pharmaceutical care | Experimental | Other: Pharmaceutical CareThe intervention consist of a pharmacist providing pharmaceutical care with aim to improve the treatment outcomes. It will be in the form of a single face-to-face session by pharmacist. Moreover, a specially designed rheumatoid arthritis disease education literature will be provided in both Urdu and English languages to patients for home use. The patients will be provided a contact number at which the pharmacist will be available at all times for the next three months (week 12). A specially designated counselling area in the pharmacy department of the hospitals served as venues for intervention. |
| Control: Usual Care | No intervention | –The patient in control group will have usual care without pharmacist intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patients with musculoskeletal illnesses other than rheumatoid arthritis
- Patients with a recent history of surgery or planned surgery for rheumatoid arthritis
- Patients with more than three co-morbidities
- Patients with any lab abnormalities, being treated for liver or kidney disease
- Patients who have had a severe infection and have completed antibiotic course in the last week
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 |
|---|---|---|
| Pharmaceutical CarePharmaceutical care is an individualized patient-centric health service delivered by pharmacists that incorporates, but is not limited to, disease education, therapy management, self-care and self-management of disease and therapy as well as motivational guidance. | Other | Intervention: Pharmacist-delivered pharmaceutical care |
Primary outcome
Rheumatoid arthritis disease knowledge
Time frame: 3 months
Patient knowledge regarding rheumatoid arthritis will be assessed after three months (week 12) from baseline (week 0). The Rheumatoid Knowledge Assessment Scale (RAKAS) will be used to measure rheumatoid arthritis disease knowledge. The RAKAS is a thirteen-item scale that contains questions related to knowledge, symptoms, treatment and risk factors. The items are multiple choice questions (MCQs) and correct answer awards a score while the wrong answers provides no score. A cumulative score is calculated which is interpreted as excellent, good, low and poor knowledge.
Treatment adherence
Time frame: 3 months
Patient adherence to rehabilitation/physical therapy after three months (week 12) from baseline (week 0). The assessment of adherence to rehabilitation/physical therapy, will be done through Urdu version of General Rehabilitation Adherence Scale (GRAS).
Medication adherence
Time frame: 3 months
Patient adherence to medication therapy after three months (week 12) from baseline (week 0). For the assessment of adherence to medication and pharmacotherapy, the Urdu version of General Medication Adherence Scale (GMAS) will be used.
Health related quality of life (HRQoL)
Time frame: 3 months
It will be assessed after three months (week 12) from baseline (week 0).The EQ-5D-5L is a generic tool to measure health and provides a numeric value for health status of patient. The score is then calculated as per the criteria specified by the EuroQol.
2 secondary outcomes
Direct cost of treatment
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
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 24 Mar 2020.
- Derived from this study: PubMed 31399128Naqvi AA, Hassali MA, Naqvi SBS, Aftab MT. Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2019 Aug 9;20(1):488. doi: 10.1186/s13063-019-3540-z.
- 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.
Mohamed 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 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 0 inclusion and 9 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 24 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?
Rheumatoid arthritis disease knowledge (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827148, which also lists 1 linked publication.
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 24 Mar 2020.