Trial Outcomes & Findings for Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement (NCT NCT02498834)
NCT ID: NCT02498834
Last Updated: 2019-01-16
Results Overview
This will be measured via the 5-item Asthma Control Test, responses are summed to indicate a score ranging from 5 (poor asthma control) to 25 (complete asthma control). A higher score means a better outcome. A score of above 19 is considered "well controlled".
COMPLETED
NA
359 participants
12 month follow-up
2019-01-16
Participant Flow
Participant milestones
| Measure |
Educational Video and Question Prompt List
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
Educational Video and Question Prompt List: Educational Video and Question Prompt List
|
Control Group
Standard of care will be used
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
174
|
|
Overall Study
COMPLETED
|
175
|
164
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Baseline characteristics by cohort
| Measure |
Educational Video and Question Prompt List
n=185 Participants
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
Educational Video and Question Prompt List: Educational Video and Question Prompt List
|
Control Group
n=174 Participants
Standard of care will be used
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.2 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
13.2 years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
13.2 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
314 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
24 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
185 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
359 Participants
n=206 Participants
|
|
Number of Participants Achieving Asthma Control
Controlled
|
101 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Number of Participants Achieving Asthma Control
Not controlled
|
84 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Adolescent asthma management self-efficacy score
|
55.9 score on a scale
STANDARD_DEVIATION 8.0 • n=99 Participants
|
56.0 score on a scale
STANDARD_DEVIATION 8.2 • n=107 Participants
|
55.9 score on a scale
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Asthma quality-of-life score
|
5.7 score on a scale
STANDARD_DEVIATION 1.2 • n=99 Participants
|
5.8 score on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
5.7 score on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
This will be measured via the 5-item Asthma Control Test, responses are summed to indicate a score ranging from 5 (poor asthma control) to 25 (complete asthma control). A higher score means a better outcome. A score of above 19 is considered "well controlled".
Outcome measures
| Measure |
Educational Video and Question Prompt List
n=174 Participants
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
Educational Video and Question Prompt List: Educational Video and Question Prompt List
|
Control Group
n=164 Participants
Standard of care will be used
|
|---|---|---|
|
Number of Participants Achieving Asthma Control
Not controlled
|
53 Participants
|
36 Participants
|
|
Number of Participants Achieving Asthma Control
Controlled
|
121 Participants
|
128 Participants
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
Adolescent asthma management self-efficacy was measured using a 14-item scale that has been shown to have a reliability of 0.87. Prior work in asthma has found asthma management self-efficacy to change in response to an intervention. Scores range from 14 to 70 and a higher score means a better outcome.
Outcome measures
| Measure |
Educational Video and Question Prompt List
n=174 Participants
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
Educational Video and Question Prompt List: Educational Video and Question Prompt List
|
Control Group
n=164 Participants
Standard of care will be used
|
|---|---|---|
|
Adolescent Asthma Management Self-efficacy Score
|
58.9 score on a scale
Standard Deviation 8.6
|
59.7 score on a scale
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: 12 month follow-upPopulation: One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.
Adolescent quality-of-life was measured as a continuous variable. The investigators used the standardized version of the Juniper pediatric asthma quality-of-life questionnaire. The questionnaire contains 23 items and has a reliability of 0.84. Scores can range from 1.0 to 7.0, and a higher score means a better outcome.
Outcome measures
| Measure |
Educational Video and Question Prompt List
n=174 Participants
Parents and adolescents in this group will watch a short educational video in English or Spanish on an iPad about the importance of encouraging adolescents to ask questions and to be involved during their pediatric asthma visits to improve their self-management skills. Also, the adolescents in this group will be handed a question prompt list to complete, which will be collected after the medical visit.
Educational Video and Question Prompt List: Educational Video and Question Prompt List
|
Control Group
n=164 Participants
Standard of care will be used
|
|---|---|---|
|
Asthma Quality-of-life Score
|
6.1 score on a scale
Standard Deviation 1.2
|
6.2 score on a scale
Standard Deviation 0.98
|
Adverse Events
Educational Video and Question Prompt List
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Betsy Sleath, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place