The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes

NCT ID: NCT05933369

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2023-10-31

Brief Summary

The goal of this trial is to determine whether or not clinical pharmacist led intervention for 3 months improves asthma control of asthmatic patients' outcomes as compared to the usual care 2023. The main question it aims to answer is does clinical pharmacist led interventions improve patient outcomes of asthmatic patients? Patients in the intervention group will receive a protocol-defined intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits. Patients in the control group will receive the usual pharmacist care.

Detailed Description

There are poor patient outcomes in the study area as it is evident in previous studies where almost ninety five percent of patients had not well controlled Asthma. Moreover, the rate of non-adherence to inhalational anti asthmatics is high and more than half of asthmatic patients received inappropriate treatment. All those poor patient outcomes can be easily prevented and those studies have recommended that patient education and proper patient consultation to optimize the benefits of treatment by integrating clinical pharmacists. Thus, pharmacists are at sealing point at which most of medication information must be provided if a conducive system is created which can greatly improve patient's treatment outcome.

This study will generate strong evidence on the impact of clinical pharmacists at improving asthma control. It will also be an excellent tool in ascertaining and promoting what a well-trained clinical pharmacist can contribute to the health care through patient centered practice. Currently, there are a great number of clinical pharmacists who are wasting their knowledge and skill in a routine and traditional way of dispensing despite they are well trained to provide a patient centered care which in turn curb many limitations of a traditional way of dispensing with a minimal patient contact time and provision of in adequate information to them.

Despite the importance of clinical pharmacists services to the improvement of asthma outcomes, clinical pharmacists face many challenges in the involvement of asthma patients, such as poor awareness among general public, lack of specific legislation and recognition from other health care providers Previously done studies have shown that clinical pharmacist led interventions had improvements in asthma outcomes. However, evidence for different interventions is not totally conclusive; Therefore, the present randomized controlled trial will set up to study the hypothesis that such pharmacist intervention will result in an improved asthma control in adult patients over a 6-month period.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Patients in the intervention group will receive a protocol-defined clinical pharmacist intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits.

Group Type: EXPERIMENTAL

Clincal pharmacist intervention

Intervention Type: BEHAVIORAL

Patients in the intervention group will receive a protocol-defined intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits for education on disease and treatment 40 minutes, administration and dosage 6 minutes, drug interaction and other drug therapy problems 20 minutes for a total of 66 minutes. The intervention will include education about asthma triggers and the need of minimizing them, asthma symptoms, warning signs, proper inhalation use technique, cigarette smoking cession when appropriate, the need of adherence and they will also counseled to wash their mouth after the use of controller medications. In addition, pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly and finally every intervention provided will be recorded.

Control

Patients in the control group will receive the usual pharmacist care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clincal pharmacist intervention

Patients in the intervention group will receive a protocol-defined intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits for education on disease and treatment 40 minutes, administration and dosage 6 minutes, drug interaction and other drug therapy problems 20 minutes for a total of 66 minutes. The intervention will include education about asthma triggers and the need of minimizing them, asthma symptoms, warning signs, proper inhalation use technique, cigarette smoking cession when appropriate, the need of adherence and they will also counseled to wash their mouth after the use of controller medications. In addition, pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly and finally every intervention provided will be recorded.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or older
• Physician's diagnosis of asthma

Exclusion Criteria

• Participation in another asthma education program
• Pregnancy
• Communication difficulties
• Seasonal asthma (asthma symptoms that only occur in a seasonal pattern)
• Other pathologies such as COPD, emphysema, lung cancer, respiratory infection
• Terminal illness (any disease that is reasonably expected to result in the patient's death)
• Having an asthma control test level of <15 (indicating seriously uncontrolled asthma; for ethical reasons, these patients will be immediately referred ) or
• Having an asthma control test level equaling 25 (indicating complete asthma control; no room for improvement) will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gondar

OTHER

Sponsor Role: lead

Responsible Party

Eden Abetu Mehari

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eden A Mehari, Msc

Role: PRINCIPAL_INVESTIGATOR

University of Gondar

Locations

University of Gondar Specialized and Comprehensive Hospital

Gonder, , Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Eden A Mehari, Msc

Role: CONTACT

edenabetu@gmail.com

+251988214167

Facility Contacts

Eden A Mehari, Msc

Role: primary

edenabetu@gmail.com

+251988214167

Abrham W Dagne, PhD

Role: backup

leabrham@gmail.com

Other Identifiers

ASTHMA-PHAR

Identifier Type: -

Identifier Source: org_study_id