- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743181
Impact of Clinical Pharmacy Services Provided for Patients With Active Rheumatoid Arthritis
January 8, 2020 updated by: hager omar mohammed siddik
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
54
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
-
-
Abasiya
-
Cairo, Abasiya, Egypt, 11566
- Facuty of Pharmacu Ain Shams University
-
-
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
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients with cognitive impairment.
- The presence of hepatic or renal disease.
- The presence of other rheumatic and connective tissue disorders.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
intervention
will be supplied by pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.
|
detection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life
|
|
control
will received standard care by physician in attendance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
disease activity score
Time Frame: 6 months
|
disease activity score-28 (DAS-28) for measuring disease activity in rheumatoid arthritis patients
|
6 months
|
|
Quality of life questionnaire
Time Frame: 6 months
|
Rheumatoid arthritis quality of life questionnaire (RAQOL) for measuring quality of life
|
6 months
|
|
Health assessment questionnaire
Time Frame: 6 months
|
Health assessment questionnaire (HAQ) for measuring functional status in rheumatoid arthritis patients
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hager omar m siddik, teaching assistant at faculty of pharmacy ain shams university
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)
January 14, 2018
Primary Completion (Actual)
October 10, 2019
Study Completion (Actual)
December 18, 2019
Study Registration Dates
First Submitted
November 4, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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