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Completed

NCT Number: NCT05664347

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

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.

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Key information

Conditions

COPD Asthma Behavior Bronchial Diseases Chronic Disease Disease Attributes Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inhaled Steroid Dependent Asthma Lung Diseases Lung Diseases, Obstructive Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Verbal teach to goal education

Behavioral

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.

Other names: verbal TTG

Video based teach to goal education

Behavioral

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.

Other names: video-based TTG

Primary outcomes

  1. Number of participants with correct Inhaler technique

    Time frame: At base line "first interview"

    The ability of the participants to use their inhaler devices correctly: using standardized checklists

  2. Number of participants with correct Inhaler technique

    Time frame: After three months of intervention "second interview"

    The ability of the participants to use their inhaler devices correctly: using standardized checklists

Secondary outcomes

  1. Number of participants with moderate-high medication adherence

    Time frame: At base line "first interview"

    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.

  2. Number of participants with moderate-high medication adherence

    Time frame: After Three months of intervention "second interview"

    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.

  3. Number of asthmatic patients with well-controlled Disease

    Time frame: At base line "first interview"

    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.

  4. Number of asthmatic patients with well-controlled Disease

    Time frame: After Three months of intervention "second interview"

    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.

  5. Number of COPD patients with well-controlled Disease

    Time frame: At base line "first interview"

    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".

  6. Number of COPD patients with well-controlled Disease

    Time frame: After Three months of intervention "second interview"

    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".

  7. Asthma related quality of life

    Time frame: At base line "first interview"

    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.

  8. Asthma related quality of life

    Time frame: After Three months of intervention "second interview"

    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.

  9. COPD related quality of life

    Time frame: At base line "first interview"

    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.

  10. COPD related quality of life

    Time frame: After Three months of intervention "second interview"

    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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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