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

NCT05933369 | Unknown DMC

• 1 other identifier: ASTHMA-PHAR
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

ASTHMA-PHAR; Asthma; Clinical pharmacist led intervention

Outcome Measures

Primary Outcomes (1)

• Change in the level of asthma control

  A blinded investigator will assess change in asthma control using the Asthma control test score (ACT). This is a clinically validated asthma control measure that consists of five questions with five alternative responses (classified by decreasing level of asthma control, scored from 5 to 1). The ACT score (range 5-25) is calculated by adding the responses to the five questions; the higher the score, the better asthma control. The ACT will be completed at randomization, as well as 1, 3, and 6 months later. Patients with a maximum score of 25 will be considered "completely controlled," while those with an ACT score of 20-24 will be considered as having "well-managed" asthma, and those with a score of 15-19 will be categorized as "uncontrolled" asthma.

  change in asthma control at 1,3 and 6 month

Secondary Outcomes (6)

• Number of exacerbations of asthma

  6 month

• Improvement in Adherence level

  6 month

• Change in Inhalation technique skill

  6 month

• change in Knowledge about disease and treatment

  6 month

• Number of Drug therapy problems reduced

  6 month

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Clincal pharmacist intervention

Control

NO INTERVENTION

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

Interventions

Clincal pharmacist intervention 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gondar: lead

Study Sites (1)

University of Gondar Specialized and Comprehensive Hospital

Gonder, Ethiopia

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eden A Mehari, Msc

  University of Gondar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eden A Mehari, Msc

CONTACT

+251988214167; edenabetu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor assessing patient outcomes will be blind. The participants and the intervention providers (Clinical pharmacists) will not be blind for patient assignment to one of the trial groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: July 6, 2023
• Study Start: June 27, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The time frame will start from the time when summary data are published or start 6 months after publication.
• Access Criteria: PD and additional supporting data information will be shared through open-access journals.

Locations

ET (1)