Trial Outcomes & Findings for Pre/Post Pilot Test of Video Module Education (NCT NCT02278237)
NCT ID: NCT02278237
Last Updated: 2019-06-04
Results Overview
Assess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways: 1. Correct Use (i.e., \>75% of steps correct) 2. Mastery (i.e., perfect technique, 100% steps correct)
COMPLETED
NA
90 participants
Up to 30 days
2019-06-04
Participant Flow
Participant milestones
| Measure |
VME Group
Video Module Education (VME): The RE will provide participants with a tablet device and will demonstrate how to access VME and complete the pre/post e-learning assessments. The RE will provide technical support but will neither participate directly in the education nor help with the self-assessments. The participants will first complete the pre-assessment e-learning tool on the tablet. They will then watch the video instruction that will provide a complete demonstration with verbal instructions on correct inhaler technique. Next the participants will complete the post-assessment e-learning tool. Based on participants' performance, they will be directed to further tailored video-instruction. The cycle of self-assessment and video instruction will continue until sufficient mastery has been achieved.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre/Post Pilot Test of Video Module Education
Baseline characteristics by cohort
| Measure |
VME Group
n=90 Participants
Video Module Education (VME)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysAssess patient's inhaler technique using Inhaler checklists by the trained assessor. The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit We will define inhaler technique in two ways: 1. Correct Use (i.e., \>75% of steps correct) 2. Mastery (i.e., perfect technique, 100% steps correct)
Outcome measures
| Measure |
VME Group
n=83 Participants
Video Module Education (VME)
|
|---|---|
|
Number of Participants With Inhaler Misuse Pre- and Post-VME
Misuse pre-VME
|
83 participants
|
|
Number of Participants With Inhaler Misuse Pre- and Post-VME
Misuse post-VME
|
24 participants
|
SECONDARY outcome
Timeframe: up to 30 daysAssess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 daysUse validated disease specific QOL tools (i.e., asthma or COPD QOL tools)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 daysAssess patient's confidence in using their inhalers. We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: "I am confident that I know how to use this respiratory inhaler correctly".
Outcome measures
Outcome data not reported
Adverse Events
VME Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place