AsthmaNCT05933369
The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes
A study testing Clincal pharmacist intervention in people with Asthma, run by University of Gondar at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Clincal pharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Jun 2023to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Physician's diagnosis of asthma
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
University of Gondar Specialized and Comprehensive Hospital
Gonder
Eden A Mehari, Msc, +251988214167, edenabetu@gmail.com
Abrham W Dagne, PhD, leabrham@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Clincal pharmacist intervention
- Keywords
- ASTHMA-PHAR, Asthma, Clinical pharmacist led intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clincal pharmacist interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Clincal pharmacist intervention |
| Control | No intervention | Patients in the control group will receive the usual pharmacist care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change in asthma control at 1,3 and 6 month
Secondary outcomes (6)
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
Measured: 6 month
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.
Measured: 6 month
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%).
Measured: 6 month
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.
Measured: 6 month
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.
Measured: 6 month
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)).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start27 Jun 2023
- Primary completionJul 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gondar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eden Abetu Mehari, University of Gondar
- Investigators
- Eden A Mehari, Msc, Principal investigator, University of Gondar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933369
- Sponsor's protocol ID
- ASTHMA-PHAR
- Status last verified
- Jun 2023
- First submitted
- 21 Mar 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified analytical dataset will be posted in an open access repository upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05933369
- Acronym / sponsor ID
- ASTHMA-PHAR
- Conditions
- Asthma
- Keywords
- ASTHMA-PHAR, Asthma, Clinical pharmacist led intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of GondarUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Clincal pharmacist interventionPatients 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. |
| Control | No intervention | –Patients in the control group will receive the usual pharmacist care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 18 years or older
- Physician's diagnosis of asthma
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clincal pharmacist interventionPatients 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. | Behavioural | Intervention |
Primary outcome
Change in the level of asthma control
Time frame: change in asthma control at 1,3 and 6 month
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.
6 secondary outcomes
Number of exacerbations of asthma
Time frame: 6 month
Improvement in Adherence level
Time frame: 6 month
Change in Inhalation technique skill
Time frame: 6 month
change in Knowledge about disease and treatment
Time frame: 6 month
Number of Drug therapy problems reduced
Time frame: 6 month
Change in Asthma Quality of life
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Yes. A deidentified analytical dataset will be posted in an open access repository upon study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eden A Mehari, Msc principal investigator
University of Gondar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clincal pharmacist intervention in people with Asthma, run by University of Gondar at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eden A Mehari, Msc (+251988214167, edenabetu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of asthma control (time frame: change in asthma control at 1,3 and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.