search
Back to results

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

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Clincal pharmacist intervention
Sponsored by
University of Gondar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring ASTHMA-PHAR, Asthma, Clinical pharmacist led intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Gondar Specialized and Comprehensive HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of exacerbations of asthma
Asthma exacerbation is one that necessitates the use of oral glucocorticoids, as well as a trip to the emergency room or hospitalization
Improvement in Adherence level
Two validated measures of adherence will be used to assess adherence throughout the study: prescription refill rates and self reporting. During the trial period, the number of units of controller medicine provided to each patient will be documented, and adherence will be computed. The test of adherence to inhaler instrument (TAI) will be used to assess self reported adherence at the end of the trial (TAI).) The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma TAI scores 50, 46-49 and less than 45 will be considered as adherent, intermediate adherent and non-adherent respectively.
Change in Inhalation technique skill
The inhalation technique will be rated using an eight-point checklist for metered dosage inhalers (MDI). One point will be awarded for each correct step, and the total score for the inhalation technique will be given as a percentage of correct steps. Patients who make serious inhalation technique errors (failure to remove cap and/or shake MDI; failure to load device and/or inhale fast and deeply via device ) will be given a sum score of zero. For ethical reasons, such major errors will also be corrected in patients belonging to the control group. Good MDIs use technique: when patients respond to greater than or equal to seven the mean score of MDIs use technique (≥70%). Poor MDIs use technique: when patients respond to less than seven the mean score of MDIs use technique (< 70%).
change in Knowledge about disease and treatment
An updated version of the Knowledge of Asthma and Asthma Medicine questionnaire will be used to assess patients' knowledge of asthma and its treatment at the start of the intervention period and after the 6-month follow-up.
Number of Drug therapy problems reduced
Using the PCNE(Pharmaceutical Care Network Europe) Classification tool Version 6.2 from Pharmaceutical Care Network Europe (PCNE) drug therapy problems will be identified. The PCNE V 6.2 has four primary issue domains, eight primary cause domains, and five primary intervention domains. There are 37 grouped sub-domains for causes, 9 grouped sub-domains for problems, and 17 grouped sub-domains for effects.Pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly.
Change in Asthma Quality of life
Asthma-specific quality of life will be assessed at the start of the intervention period and after the 6-month follow-up period using the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)).

Full Information

First Posted
March 21, 2023
Last Updated
June 27, 2023
Sponsor
University of Gondar
search

1. Study Identification

Unique Protocol Identification Number
NCT05933369
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gondar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
ASTHMA-PHAR, Asthma, Clinical pharmacist led intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will receive the usual pharmacist care.
Intervention Type
Behavioral
Intervention Name(s)
Clincal pharmacist intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the level of asthma control
Description
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.
Time Frame
change in asthma control at 1,3 and 6 month
Secondary Outcome Measure Information:
Title
Number of exacerbations of asthma
Description
Asthma exacerbation is one that necessitates the use of oral glucocorticoids, as well as a trip to the emergency room or hospitalization
Time Frame
6 month
Title
Improvement in Adherence level
Description
Two validated measures of adherence will be used to assess adherence throughout the study: prescription refill rates and self reporting. During the trial period, the number of units of controller medicine provided to each patient will be documented, and adherence will be computed. The test of adherence to inhaler instrument (TAI) will be used to assess self reported adherence at the end of the trial (TAI).) The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma TAI scores 50, 46-49 and less than 45 will be considered as adherent, intermediate adherent and non-adherent respectively.
Time Frame
6 month
Title
Change in Inhalation technique skill
Description
The inhalation technique will be rated using an eight-point checklist for metered dosage inhalers (MDI). One point will be awarded for each correct step, and the total score for the inhalation technique will be given as a percentage of correct steps. Patients who make serious inhalation technique errors (failure to remove cap and/or shake MDI; failure to load device and/or inhale fast and deeply via device ) will be given a sum score of zero. For ethical reasons, such major errors will also be corrected in patients belonging to the control group. Good MDIs use technique: when patients respond to greater than or equal to seven the mean score of MDIs use technique (≥70%). Poor MDIs use technique: when patients respond to less than seven the mean score of MDIs use technique (< 70%).
Time Frame
6 month
Title
change in Knowledge about disease and treatment
Description
An updated version of the Knowledge of Asthma and Asthma Medicine questionnaire will be used to assess patients' knowledge of asthma and its treatment at the start of the intervention period and after the 6-month follow-up.
Time Frame
6 month
Title
Number of Drug therapy problems reduced
Description
Using the PCNE(Pharmaceutical Care Network Europe) Classification tool Version 6.2 from Pharmaceutical Care Network Europe (PCNE) drug therapy problems will be identified. The PCNE V 6.2 has four primary issue domains, eight primary cause domains, and five primary intervention domains. There are 37 grouped sub-domains for causes, 9 grouped sub-domains for problems, and 17 grouped sub-domains for effects.Pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly.
Time Frame
6 month
Title
Change in Asthma Quality of life
Description
Asthma-specific quality of life will be assessed at the start of the intervention period and after the 6-month follow-up period using the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)).
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eden A Mehari, Msc
Phone
+251988214167
Email
edenabetu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eden A Mehari, Msc
Organizational Affiliation
University of Gondar
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gondar Specialized and Comprehensive Hospital
City
Gondar
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eden A Mehari, Msc
Phone
+251988214167
Email
edenabetu@gmail.com
First Name & Middle Initial & Last Name & Degree
Abrham W Dagne, PhD
Email
leabrham@gmail.com
First Name & Middle Initial & Last Name & Degree
Eden A Mehari, Msc &MPH
First Name & Middle Initial & Last Name & Degree
Abrham W Dagne, PhD
First Name & Middle Initial & Last Name & Degree
Esileman A Muche, Msc
First Name & Middle Initial & Last Name & Degree
Sewnet A Kebede, MPH
First Name & Middle Initial & Last Name & Degree
Gebrehiwot L Legese, MD
First Name & Middle Initial & Last Name & Degree
Faisel D Sema, Msc
First Name & Middle Initial & Last Name & Degree
Gizework A Mekonnen, Msc
First Name & Middle Initial & Last Name & Degree
Rahel B Abebe, Msc
First Name & Middle Initial & Last Name & Degree
Abebech T Gelaye, Msc
First Name & Middle Initial & Last Name & Degree
Leila K Kemal, Msc
First Name & Middle Initial & Last Name & Degree
Abdulwase M Seid, Msc
First Name & Middle Initial & Last Name & Degree
Abdisa G Jara, Msc
First Name & Middle Initial & Last Name & Degree
Abiyot E Gurmu, Msc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A deidentified analytical dataset will be posted in an open access repository upon study completion.
IPD Sharing Time Frame
The time frame will start from the time when summary data are published or start 6 months after publication.
IPD Sharing Access Criteria
PD and additional supporting data information will be shared through open-access journals.

Learn more about this trial

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

We'll reach out to this number within 24 hrs