Clinical trial NCT05933369: The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes
Official title: The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes at the University of Gondar Comprehensive and Specialized Hospital, Northwest Ethiopia, 2022: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: ASTHMA-PHAR
Asthma
Clinical pharmacist led intervention
Lead sponsor: University of Gondar
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the level of asthma control
timeFrame: change in asthma control at 1,3 and 6 month
Secondary outcomes:
measure: Number of exacerbations of asthma
timeFrame: 6 month
measure: Improvement in Adherence level
timeFrame: 6 month
measure: Change in Inhalation technique skill
timeFrame: 6 month
measure: change in Knowledge about disease and treatment
timeFrame: 6 month
measure: Number of Drug therapy problems reduced
timeFrame: 6 month
measure: Change in Asthma Quality of life
timeFrame: 6 month
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: University of Gondar Specialized and Comprehensive Hospital
Study officials:
affiliation: University of Gondar
name: Eden A Mehari, Msc
role: PRINCIPAL_INVESTIGATOR
References: