Clinical trial NCT03827148: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Pharmacist intervention
Disease knowledge
Medication adherence
Rehabilitation
Physical therapy
Health related quality of life
Direct cost of treatment
Rheumatoid arthritis
Pakistan
Out-patients
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Clifton Central Hospital
First posted: 2019-02-01
Enrollment: 714
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rheumatoid arthritis disease knowledge
timeFrame: 3 months
measure: Treatment adherence
timeFrame: 3 months
measure: Medication adherence
timeFrame: 3 months
measure: Health related quality of life (HRQoL)
timeFrame: 3 months
Secondary outcomes:
measure: Direct cost of treatment
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Clifton Central Hospital
state: Sindh
Study officials:
affiliation: Universiti Sains Malaysia
name: Mohamed A Hassali, PhD
role: STUDY_DIRECTOR
References:
citation: 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.