- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381166
The Effect of İnhaler Training and Reminders on Medication on Adherence in Elderly Individuals
March 5, 2026 updated by: Sevda Ateş, Çanakkale Onsekiz Mart University
The Effect Of Metered-Dose İnhaler Training And Reminders On Medication Adherence In Elderly Individuals: A Randomized Controlled Study
This study will evaluate the effect of metered-dose inhaler training and reminders on treatment adherence in elderly individuals.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The presence of multiple comorbidities and an increased number of medications in elderly individuals are significant risk factors for non-adherence to inhaler therapy.
Forgetfulness, lack of confidence in medications and difficulty understanding how to take them, depression, low self-efficacy, disease severity, and disease perception can all affect adherence to treatment.
Incorrect inhaler use can lead to patients receiving insufficient medication, increased symptom burden, and negatively impact their quality of life.
Furthermore, incorrect inhaler technique has been shown to increase the risk of hospitalization, emergency room visits, and the use of antibiotics and oral corticosteroids.
Implementing procedures to ensure correct inhaler use is crucial in controlling critical errors in inhaler therapy.
Elderly patients are more likely to have conditions such as arthritis that affect physical movement and coordination.
Cognitive function also affects the ability to use inhaler devices correctly.
It is known that incorrect inhaler use is more common, particularly in untrained and elderly individuals, with frequent errors including poor hand-mouth coordination, inability to synchronize spraying and inhalation, and failure to hold the breath during inhalation being common mistakes in metered-dose inhaler use.
Therefore, this study will evaluate the effect of metered-dose inhaler training and reminders on treatment adherence in elderly individuals.
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sevda Ates Associate Professor
- Phone Number: 18079 +902862181397
- Email: sevdaefil@comu.edu.tr
Study Contact Backup
- Name: Sengül Uzen Cura, Associate Professor
- Phone Number: 18065 +902862181397
- Email: senguluzen@comu.edu.tr
Study Locations
-
-
-
Çanakkale, Turkey (Türkiye), 17100
- Recruiting
- Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria for the study:
- Age ≥ 65 years old
- Having at least basic literacy,
- Receiving metered-dose inhaler therapy for at least 6 months,
- Being hospitalized in the pulmonary ward,
- Presenting to the pulmonary function test unit,
- Presenting to the pulmonary outpatient clinic,
- Signing the informed consent form for participation in the study,
- Having internet access and a mobile device with Android/iOS operating system,
- Being able to use a telephone,
- Having no communication barriers,
- Being able to use the inhaler without needing assistance,
- Making an error in at least one of the usage steps according to the MDI usage skills chart.
Exclusion criteria for the study:
- Age <65
- Illiteracy
- Receiving metered-dose inhaler therapy for <6 months
- Outpatient treatment
- Being hospitalized in the intensive care unit
- Being hospitalized in wards other than the pulmonary ward (such as surgery, physical therapy)
- Visiting outpatient clinics other than the pulmonary clinic (such as surgery, physical therapy)
- Not signing the informed consent form for participation in the study
- Not having internet access and a mobile device with Android/iOS operating system
- Not having telephone skills
- Having communication barriers
- Requiring assistance while using the inhaler
- Not making any errors in the usage steps according to the MDI usage skills chart
- Wanting to withdraw from the study/withdrawing from participation during the research process
- Not completing the questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: arm description experimental
The socio-demographic and descriptive characteristics, as well as questions regarding medication adherence, included in the survey form will be answered through face-to-face interviews.
While the participant demonstrates how to apply the inhaler, the researcher will evaluate the participant's inhaler use according to the "Metered Dose Inhaler Skill Chart," which includes the steps for inhaler use.
Each participant in the experimental group will receive metered-dose inhaler training using a demonstration method.
At the end of the training, participants will be given a "Metered Dose Inhaler Use Reminder Card" and a "Metered Dose Inhaler Application Video."
Participants will also receive weekly reminders via telephone.
After 3 months, the experimental group will be contacted via video call to demonstrate how they use the inhaler.
The researcher will evaluate the participants' medication adherence scores and record them on the survey form.
If any steps are incorrectly applied, the metered
|
It is known that incorrect inhaler use is more common, especially in elderly individuals, and that common errors in metered-dose inhaler use include poor hand-mouth coordination, inability to simultaneously spray and inhale, and failure to hold the breath during inhalation.
This study evaluates metered-dose inhaler use only in elderly individuals.
Furthermore, not only will the inhaler application steps be evaluated, but the experimental group will also receive education and reminder interventions.
This reminder card contains the inhaler administration steps included in the "Measured Dose Inhaler Medication Use Skill Chart".
Participants in the experimental group will be able to access the medication administration steps on the reminder card before administering their inhaler medication.
Participants will be asked in the final interview whether they used the reminder cards.
This video was prepared by the responsible researcher, taking into account the application steps included in the "Metered Dose Inhaler Medication Use Skill Chart".
Participants in the experimental group will be able to access the application steps via the inhaler video before administering their inhaler medication.
|
|
No Intervention: arm description control
The socio-demographic and demographic characteristics, as well as questions regarding medication adherence, included in the survey form will be answered through face-to-face interviews.
While the participant demonstrates how to apply the inhaler, the researcher will evaluate the participant's inhaler use according to the "Metered Dose Inhaler Skill Chart," which includes the steps for inhaler use.
No inhaler training or reminders will be given.
Participants in the control group will be contacted by phone 3 months after the initial follow-up and asked to demonstrate how they use the inhaler.
The researcher will evaluate the participants' medication adherence scores and record them on the survey form.
After the data collection is complete, inhaler training will be given to the participants using a demonstration method.
At the end of the training, reminder cards and a video demonstrating metered-dose inhaler application will be shared with the participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metered Dose Inhaler Skill
Time Frame: the initial screening and three months after the initial screening (three months)
|
The "Measured Dose Inhaler Skill Chart" involves evaluating the participant's inhaler usage and checking the application steps.
Performing all steps correctly will be considered "correct inhaler technique," while performing at least one or more steps incorrectly or not at all will be considered "incorrect inhaler technique."
For each step, incorrect application or omission will receive "0 points," and correct application will receive "1 point," resulting in a total score between "0 and 10." Participants who make at least "1 mistake" or score "below 10" will be included in the study.
When evaluating scores based on inhaler usage steps, "0-3" points will be considered poor, "4-6" points moderate, and "7-10" points good.
|
the initial screening and three months after the initial screening (three months)
|
|
Medication Adherence Reporting Scale
Time Frame: the initial screening and three months after the initial screening (three months)
|
The scale consists of 5 items in total.
The total test score is determined by summing the scores obtained from the items.
Scores obtained from the scale range from 5 to 25.
Higher total scores indicate better medication adherence, while lower total scores indicate poor medication adherence.
|
the initial screening and three months after the initial screening (three months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SEVDA ATEŞ, Associate Professor, Canakkale Onsekiz Mart University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2026
Primary Completion (Estimated)
May 23, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
January 24, 2026
First Submitted That Met QC Criteria
January 24, 2026
First Posted (Actual)
February 2, 2026
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 5, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-SBF-SA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
In the ethics committee approval and institutional permission obtained for the study, I stated that the study would not be shared anywhere other than for publication.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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