NCT03827148

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
714

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable rheumatoid-arthritis

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

November 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

January 29, 2019

Last Update Submit

March 23, 2020

Conditions

Rheumatoid Arthritis

Keywords

Pharmacist interventionDisease knowledgeMedication adherenceRehabilitationPhysical therapyHealth related quality of lifeDirect cost of treatmentRheumatoid arthritisPakistanOut-patients

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    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.

    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.

    3 months

Secondary Outcomes (2)

  • Direct cost of treatment

    3 months

  • Patient satisfaction

    3 months

Study Arms (2)

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.

Other: Pharmaceutical Care

Control: Usual Care

NO INTERVENTION

The patient in control group will have usual care without pharmacist intervention.

Interventions

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.

Intervention: Pharmacist-delivered pharmaceutical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who meet the following criteria would be invited to participate in our study:
  • Patients suffering from rheumatoid arthritis diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR criteria.
  • Patients diagnosed with RA based on above mentioned criteria for at least 3 months prior to invitation.
  • Patients aged above 18 years
  • Patients visiting out-patient clinics only. Before enrolling in the study, patients attended a study explanation session and provided a written consent to participate.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clifton Central Hospital

Karachi, Sindh, 75600, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 31399128DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidMedication Adherence

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mohamed A Hassali, PhD

    Universiti Sains Malaysia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigators, data collectors, study observers, data entry operators and data analysis statistician will be blinded to the allocation. The patients in the control group will be blinded to pharmacists as they would not know if the person they find in the room is a pharmacist or, a data collector. Similarly, the data collector would not know if the patient belong to IG or CG. However, the patients enrolled in intervention group will not be blinded to the pharmacist considering the nature of intervention yet, the pharmacist will be blinded to the outcome assessment so that there will be less likelihood of intervention bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Atta Abbas Naqvi

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 1, 2019

Study Start

November 17, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)