Asthma Clinical Trial
Official title:
Video-based Teach-to-goal Intervention on Inhaler Technique on Adults With Asthma and COPD: a Randomized Controlled Trial
NCT number | NCT05664347 |
Other study ID # | 124454 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2020 |
Est. completion date | February 21, 2021 |
Verified date | December 2022 |
Source | University of Jordan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | February 21, 2021 |
Est. primary completion date | February 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Jordan | Jordan University Hospital | Amman |
Lead Sponsor | Collaborator |
---|---|
University of Jordan |
Jordan,
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* Note: There are 68 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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" | |
Primary | 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 | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" | |
Secondary | 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" |
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