Asthma COPDNCT06417931
Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD
A study testing Patient education and counselling in people with Asthma COPD, run by University of Ibadan at 1 site in Nigeria.
Trial summary
This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma COPD
- What is being tested?
- Patient education and counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNigeria
- Study dates
- 4 Oct 2023to 28 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access
Who cannot join
- All non-consenting patients and patients who are not on any medications at any point in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria
This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria.
Read the detailed description
Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p < 0.05.
- Conditions
- Asthma COPD
- Being tested
- Patient education and counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education and counsellingBehavioural
The pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Patients in the intervention group received education and counselling tips about their disease condition and medications Receives: Behavioral: Patient education and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
The difference between the intervention and control groups with respect to the changes in the medication adherence score from baseline to a 2-month follow-up.
Measured: Two months
Use of inhaler devices
The difference between the intervention and control groups with respect to the changes in knowledge of the use of inhaler devices from baseline to a 2-month follow-up.
Measured: Two months
Secondary outcomes (1)
disease control
The difference in asthma or Chronic obstructive pulmonary disease (COPD) control among patients in control and intervention groups from baseline to 2-months follow-up
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start4 Oct 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma COPDStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uyiose Fortress Ufuah, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417931
- Sponsor's protocol ID
- Medication adherence
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adisa R, Ufuah UF, Ige OM. Impact of pharmacist-led intervention in medication adherence and inhaler usage on asthma and chronic obstructive pulmonary disease control: a quasi-experimental study. BMC Health Serv Res. 2024 Oct 8;24(1):1199. doi: 10.1186/s12913-024-11683-9.
PubMed 39379970
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria
- ClinicalTrials.gov ID
- NCT06417931
- Acronym / sponsor ID
- Medication adherence
- Conditions
- Asthma COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 May 2024 (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.
This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria.
Detailed description
Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Patient education and counsellingPatients in the intervention group received education and counselling tips about their disease condition and medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access
Key exclusion criteria (1 listed)
- All non-consenting patients and patients who are not on any medications at any point in the study
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 |
|---|---|---|
| Patient education and counsellingThe pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies | Behavioural | Intervention |
Primary outcome
Medication adherence
Time frame: Two months
The difference between the intervention and control groups with respect to the changes in the medication adherence score from baseline to a 2-month follow-up.
Use of inhaler devices
Time frame: Two months
The difference between the intervention and control groups with respect to the changes in knowledge of the use of inhaler devices from baseline to a 2-month follow-up.
1 secondary outcome
disease control
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 39379970Adisa R, Ufuah UF, Ige OM. Impact of pharmacist-led intervention in medication adherence and inhaler usage on asthma and chronic obstructive pulmonary disease control: a quasi-experimental study. BMC Health Serv Res. 2024 Oct 8;24(1):1199. doi: 10.1186/s12913-024-11683-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education and counselling in people with Asthma COPD, run by University of Ibadan at 1 site in Nigeria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2024. 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 Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417931, which also lists 1 linked publication.
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 16 May 2024.