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 (DRAMATIC)

March 23, 2020 updated by: Atta Abbas Naqvi, Universiti Sains Malaysia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

714

Phase

  • Not Applicable

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Clifton Central Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Types of participants Inclusion criteria

The patients who meet the following criteria would be invited to participate in our study:

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

Exclusion criteria

Patients were excluded from the study if they had any of the following conditions:

  1. Patients with musculoskeletal illnesses other than rheumatoid arthritis
  2. Patients with a recent history of surgery or planned surgery for rheumatoid arthritis
  3. Patients with more than three co-morbidities
  4. Patients with any lab abnormalities, being treated for liver or kidney disease
  5. Patients who have had a severe infection and have completed antibiotic course in the last week
  6. Patients with advanced cardiovascular disease, severe allergies or a rare disease
  7. Patients who are currently participating in other clinical trial or have participated in the last three months.
  8. Pregnant patients, planning to become pregnant, breast feeding and females with other gynecological issues were not included.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Pharmacist-delivered pharmaceutical care
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
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.
No Intervention: Control: Usual Care
The patient in control group will have usual care without pharmacist intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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).
3 months
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct cost of treatment
Time Frame: 3 months
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).
3 months
Patient satisfaction
Time Frame: 3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Collaborators

Clifton Central Hospital

Investigators

  • Study Director: Mohamed A Hassali, PhD, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 17, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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