Video-based Teach-to-goal Intervention on Inhaler Technique on Jordanian Adults With Asthma and COPD

Study Overview
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Brief Summary
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This study was an interventional educational study that was intended to find out the effect of a video based inhaler technique education on improving inhaler technique mastery, disease control, medication adherence and patient quality of life in comparison to verbal education among adults with asthma or COPD.

Official Title
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Video-based Teach-to-goal Intervention on Inhaler Technique on Adults With Asthma and COPD: a Randomized Controlled Trial

Conditions
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COPD, Asthma, Inhaled Steroid Dependent Asthma

Intervention / Treatment
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* Behavioral: Verbal teach to goal education
* Behavioral: Video based teach to goal education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established diagnosis of Asthma or COPD. Started on one or more inhaler devices for a minimum of one month. Expected to continue using their inhaler devices chronically. Exclusion Criteria: Patients at high risk of infection (immunocompromised). Patients presenting with a very severe clinical presentation (severe dyspnoea, confusion due to hypoxemia, the need for continuous oxygen therapy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients diagnosed with asthma or COPD, who were started on any inhaler for a minimum of one month and will continue using them chronically were met in the JUH respiratory clinic and invited to participate. Patients at high risk for infection, or those presenting with a very severe clinical presentation were excluded. Taking into account the non-invasive nature of the educational intervention, and the need to reduce the risk of spread of COVID19 virus (sharing pens or papers), a verbal consent was obtained. Enrolled participants were randomized using simple randomization into two groups; odd numbers for the control group (received a verbal TTG education on their inhaler technique) and even numbers for the intervention group ( received a video based TTG education). The primary and secondary outcomes of the study were inhaler technique mastery, amelioration of disease control, disease related quality of life and medication adherence at follow-up (after 3 months).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard verbal teach to goal inhaler technique education | Behavioral: Verbal teach to goal education<br>* Participants were showed how to use correctly their inhalers and then asked again to show the technique. For each incorrect step, the patients were corrected and asked to repeat the steps until they mastered the technique. This process was repeated a maximum of three times.<br>* Other names: verbal TTG;|
| Active Comparator: Intervention<br>Video based teach to goal inhaler technique education | Behavioral: Video based teach to goal education<br>* Participants were educated by the a video-based teach to goal method. using a smartphone, an educational video illustrating the correct technique for each of the inhalers used by the patient was displayed. After watching the video, the patients were asked to show again how to use their inhaler and for each wrong step the video was displayed again until mastering the correct technique a maximum of three times. At the end of the interview participants in the intervention group received a copy of the video via WhatsApp and were all invited to watch the video whenever needed.<br>* Other names: video-based TTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with correct Inhaler technique | The ability of the participants to use their inhaler devices correctly: using standardized checklists | At base line first interview | 
| Number of participants with correct Inhaler technique | The ability of the participants to use their inhaler devices correctly: using standardized checklists | After three months of intervention second interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with moderate-high medication adherence | Adherence to inhaled medications used for the management of Asthma or COPD using morisky-green levien scale (MGLS). This scale is a 4 point previously validated score for the assessment of medication adherence, increase in score from 1 to 4 means better medication adherence. patients with a MGLS of 1 were considered to have low medication adherence while those with a score that is equal or higher than 2 were considered to have moderate-high level of adherence. | At base line first interview | 
| Number of participants with moderate-high medication adherence | Adherence to inhaled medications used for the management of Asthma or COPD using morisky-green levien scale (MGLS). This scale is a 4 point previously validated score for the assessment of medication adherence, increase in score from 1 to 4 means better medication adherence. patients with a MGLS of 1 were considered to have low medication adherence while those with a score that is equal or higher than 2 were considered to have moderate-high level of adherence. | After Three months of intervention second interview | 
| Number of asthmatic patients with well-controlled Disease | Assessment of symptom frequency and severity using the Asthma control test (ACT). a scale of 25 points, the minimum score is 5 points which indicates the worst symptom control while the maximum score best disease control is indicated by the score of 25. Patients with a score of 5-19 were considered having uncontrolled asthma while those with a score of 20-25 had a well controlled asthma. | At base line first interview | 
| Number of asthmatic patients with well-controlled Disease | Assessment of symptom frequency and severity using the Asthma control test (ACT). a scale of 25 points, the minimum score is 5 points which indicates the worst symptom control while the maximum score best disease control is indicated by the score of 25. Patients with a score of 5-19 were considered having uncontrolled asthma while those with a score of 20-25 had a well controlled asthma. | After Three months of intervention second interview | 
| Number of COPD patients with well-controlled Disease | Assessment of symptom frequency and severity using the COPD assessment test. a scale of 40 points; disease control is considered better as the score decreases. participants with scores of 0-9 were considered having less symptoms well controlled COPD while those with a score between 10-40 were considered having more symptoms less controlled COPD. | At base line first interview | 
| Number of COPD patients with well-controlled Disease | Assessment of symptom frequency and severity using the COPD assessment test. a scale of 40 points; disease control is considered better as the score decreases. participants with scores of 0-9 were considered having less symptoms well controlled COPD while those with a score between 10-40 were considered having more symptoms less controlled COPD. | After Three months of intervention second interview | 
| Asthma related quality of life | Assessment of asthmatic patients quality of life using the mini asthma quality of life questionnaire (mini-AQLQ). A 15 questions scale with a score of 1-7 for each question. average score was calculated to give a result between 1-7. as the average score increased from 1-7 the disease related quality of life was considered better; total impairment highly impaired very impaired moderately impaired somehow impaired little impairment no impairment. | At base line first interview | 
| Asthma related quality of life | Assessment of asthmatic patients quality of life using the mini asthma quality of life questionnaire (mini-AQLQ). A 15 questions scale with a score of 1-7 for each question. average score was calculated to give a result between 1-7. as the average score increased from 1-7 the disease related quality of life was considered better; total impairment highly impaired very impaired moderately impaired somehow impaired little impairment no impairment. | After Three months of intervention second interview | 
| COPD related quality of life | Assessment of COPD patients quality of life using the St.George respiratory questionnaire. a 50-item validated tool. Each question had a specific weight assigned by the developer and the SGRQ scores are calculated using an automated application that was also designed and afforded by the questionnaire developer. The automated application can thus produce four final results; a total score that represents the total burden of COPD on the patient's quality of life, a 'symptom' score, an 'activity limitation' score and an 'impact' score. The total SGRQ score and the score for each of the three domains can range from 0 to 100, where an increase in the score indicates more impairment exerted by the disease on the patient's QoL. | At base line first interview | 
| COPD related quality of life | Assessment of COPD patients quality of life using the St.George respiratory questionnaire. a 50-item validated tool. Each question had a specific weight assigned by the developer and the SGRQ scores are calculated using an automated application that was also designed and afforded by the questionnaire developer. The automated application can thus produce four final results; a total score that represents the total burden of COPD on the patient's quality of life, a 'symptom' score, an 'activity limitation' score and an 'impact' score. The total SGRQ score and the score for each of the three domains can range from 0 to 100, where an increase in the score indicates more impairment exerted by the disease on the patient's QoL. | After Three months of intervention second interview | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-Based, Teach To Goal Education, Chronic Obstructive Pulmonary Disease, Asthma, Randomized Controlled Trial, Patient Education, Quality of Life, Medication adherence, Inhaler technique