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

December 17, 2022 updated by: Oriana Awwad, University of Jordan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

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 Locations

  • Jordan
      • Amman, Jordan
        • Jordan University Hospital

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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
Active Comparator: Control
Standard verbal teach to goal inhaler technique education
Behavioral: Verbal teach to goal education
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
Active Comparator: Intervention
Video based teach to goal inhaler technique education
Behavioral: Video based teach to goal education
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At base line "first interview"
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
After three months of intervention "second interview"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At base line "first interview"
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.
After Three months of intervention "second interview"
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.
At base line "first interview"
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.
After Three months of intervention "second interview"
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".
At base line "first interview"
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".
After Three months of intervention "second interview"
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;

  1. total impairment
  2. highly impaired
  3. very impaired
  4. moderately impaired
  5. somehow impaired
  6. little impairment
  7. no impairment.
At base line "first interview"
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;

  1. total impairment
  2. highly impaired
  3. very impaired
  4. moderately impaired
  5. somehow impaired
  6. little impairment
  7. no impairment.
After Three months of intervention "second interview"
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.
At base line "first interview"
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.
After Three months of intervention "second interview"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 9, 2020

Primary Completion (Actual)

February 21, 2021

Study Completion (Actual)

February 21, 2021

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

December 17, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 17, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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