NCT03743181

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

November 4, 2018

Last Update Submit

January 8, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • disease activity score

    disease activity score-28 (DAS-28) for measuring disease activity in rheumatoid arthritis patients

    6 months

  • Quality of life questionnaire

    Rheumatoid arthritis quality of life questionnaire (RAQOL) for measuring quality of life

    6 months

  • Health assessment questionnaire

    Health assessment questionnaire (HAQ) for measuring functional status in rheumatoid arthritis patients

    6 months

Study Arms (2)

intervention

will be supplied by pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance.

Other: pharmaceutical care services

control

will received standard care by physician in attendance

Interventions

detection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life

intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

rheumatoid arthritis patients from outpatient clinics - Ain shams university hospitals

You may qualify if:

  • 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)

You may not qualify if:

  • Patients with cognitive impairment.
  • The presence of hepatic or renal disease.
  • The presence of other rheumatic and connective tissue disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facuty of Pharmacu Ain Shams University

Cairo, Abasiya, 11566, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • hager omar m siddik

    teaching assistant at faculty of pharmacy ain shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assistant at clinical pharmacy department at faculty of pharmacy ain shams university

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 16, 2018

Study Start

January 14, 2018

Primary Completion

October 10, 2019

Study Completion

December 18, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations