Rheumatoid ArthritisNCT03743181
Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by hager omar mohammed siddik at 1 site in Egypt.
Trial summary
Enrolment of clinical pharmacy services in RA patients as a part of health care system has been investigated at many studies but not investigated in active RA patients before. This study aimed to detect drug therapy-related problems (DTRPs) in active rheumatoid arthritis (RA) patients and Investigate the impact of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- pharmaceutical care services
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2018to 18 Dec 2019
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals
Who may be able to join
- Patients aged 18-60 years old
- fulfillment of the American College of Rheumatology /European league against rheumatism (2010 ACR/EULAR ) diagnostic criteria for RA.
- patients with active RA(defined by DAS28 score < 5.1)
Who cannot join
- Patients with cognitive impairment.
- The presence of hepatic or renal disease.
- The presence of other rheumatic and connective tissue disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Enrolment of clinical pharmacy services in RA patients as a part of health care system has been investigated at many studies but not investigated in active RA patients before. This study aimed to detect drug therapy-related problems (DTRPs) in active rheumatoid arthritis (RA) patients and Investigate the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life (QoL). Methods:Prospective, randomized controlled study to be carried out at rheumatology outpatient clinic, Ain Shams University Hospitals on 50 patients with active RA for 6 months.determine if any drug therapy problems are present.Develop a plan of care that includes interventions to resolve drug therapy problems, achieve goals of therapy, and prevent drug therapy problems. questionnaires was used to measure functional status in RA patients using health assessment questionnaire (HAQ) and assess self-reported quality of life in patients with (RA) using rheumatoid arthritis quality of life questionnaire (RAQOL) and measure adherence using the 4-item Morisky Green Levine Medication Adherence Scale and Disease Activity Score-28 was used as an objective method to assess RA disease activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- pharmaceutical care services
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical care servicesOther
detection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life
| Study group | Role | What they receive |
|---|---|---|
| intervention | will be supplied by pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance. Receives: Other: pharmaceutical care services | |
| control | will received standard care by physician in attendance |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity score
disease activity score-28 (DAS-28) for measuring disease activity in rheumatoid arthritis patients
Measured: 6 months
Quality of life questionnaire
Rheumatoid arthritis quality of life questionnaire (RAQOL) for measuring quality of life
Measured: 6 months
Health assessment questionnaire
Health assessment questionnaire (HAQ) for measuring functional status in rheumatoid arthritis patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start14 Jan 2018
- Primary completion10 Oct 2019
- Study completion18 Dec 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- hager omar mohammed siddik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hager omar mohammed siddik, Ain Shams University
- Investigators
- hager omar m siddik, Principal investigator, teaching assistant at faculty of pharmacy ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743181
- Sponsor's protocol ID
- 156
- Status last verified
- Jan 2020
- First submitted
- 4 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03743181
- Acronym / sponsor ID
- 156
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- hager omar mohammed siddikUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 16 Nov 2018 (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.
Enrolment of clinical pharmacy services in RA patients as a part of health care system has been investigated at many studies but not investigated in active RA patients before. This study aimed to detect drug therapy-related problems (DTRPs) in active rheumatoid arthritis (RA) patients and Investigate the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life (QoL). Methods:Prospective, randomized controlled study to be carried out at rheumatology outpatient clinic, Ain Shams University Hospitals on 50 patients with active RA for 6 months.determine if any drug therapy problems are present.Develop a plan of care that includes interventions to resolve drug therapy problems, achieve goals of therapy, and prevent drug therapy problems. questionnaires was used to measure functional status in RA patients using health assessment questionnaire (HAQ) and assess self-reported quality of life in patients with (RA) using rheumatoid arthritis quality of life questionnaire (RAQOL) and measure adherence using the 4-item Morisky Green Levine Medication Adherence Scale and Disease Activity Score-28 was used as an objective method to assess RA disease activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Other: pharmaceutical care serviceswill be supplied by pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance. |
| control | – | –will received standard care by physician in attendance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals
Key inclusion criteria (3 listed)
- Patients aged 18-60 years old
- fulfillment of the American College of Rheumatology /European league against rheumatism (2010 ACR/EULAR ) diagnostic criteria for RA.
- patients with active RA(defined by DAS28 score < 5.1)
Key exclusion criteria (3 listed)
- Patients with cognitive impairment.
- The presence of hepatic or renal disease.
- The presence of other rheumatic and connective tissue disorders.
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 care servicesdetection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life | Other | intervention |
Primary outcome
disease activity score
Time frame: 6 months
disease activity score-28 (DAS-28) for measuring disease activity in rheumatoid arthritis patients
Quality of life questionnaire
Time frame: 6 months
Rheumatoid arthritis quality of life questionnaire (RAQOL) for measuring quality of life
Health assessment questionnaire
Time frame: 6 months
Health assessment questionnaire (HAQ) for measuring functional status in rheumatoid arthritis patients
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 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
hager omar m siddik principal investigator
teaching assistant at faculty of pharmacy ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by hager omar mohammed siddik at 1 site in Egypt.
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 3 inclusion and 3 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 13 Jan 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 Egypt. 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 activity score (time frame: 6 months). The study lists 3 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 13 Jan 2020.