Trial Outcomes & Findings for Teen Asthma Project (NCT NCT01161225)
NCT ID: NCT01161225
Last Updated: 2014-12-15
Results Overview
Twenty-three items cover problems identified as being most important and troublesome in children's everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)
COMPLETED
NA
126 participants
9 months post camp
2014-12-15
Participant Flow
Participant milestones
| Measure |
Intervention Group
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
53
|
14
|
|
Overall Study
COMPLETED
|
45
|
44
|
12
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Teen Asthma Project
Baseline characteristics by cohort
| Measure |
Intervention Group
n=59 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=53 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=14 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.31 years
STANDARD_DEVIATION 1.36 • n=93 Participants
|
14.97 years
STANDARD_DEVIATION 1.29 • n=4 Participants
|
18.28 years
STANDARD_DEVIATION 1.90 • n=27 Participants
|
15.50 years
STANDARD_DEVIATION 1.71 • n=483 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=93 Participants
|
53 participants
n=4 Participants
|
14 participants
n=27 Participants
|
126 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 9 months post campPopulation: The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
Twenty-three items cover problems identified as being most important and troublesome in children's everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
|
140.30 units on a scale
Standard Deviation 21.04
|
125.12 units on a scale
Standard Deviation 25.95
|
138.11 units on a scale
Standard Deviation 16.44
|
PRIMARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
This measure assesses the frequencies of the limitation of daily activity, asthma symptoms (daytime and nighttime) and use of rescue medication in the past 4 weeks on a 5-point scale (0-4). Total summed scores were computed (range: 4-16). Higher total scores indicate better controlled asthma.
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Asthma Control Questions
|
14.84 units on a scale
Standard Deviation 1.86
|
14.19 units on a scale
Standard Deviation 1.83
|
14.89 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
This 14-item scale was developed to measure the child's confidence in attack prevention (e.g., learn asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). Total summed scores were computed (range: 21-70). Higher total scores indicate greater degree of self-efficacy.
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Asthma Self-Efficacy
|
56.19 units on a scale
Standard Deviation 10.02
|
51.93 units on a scale
Standard Deviation 9.09
|
57.44 units on a scale
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
This 29-item scale was developed to assess perception of barriers and to predict risk for poor self-management in adolescents with chronic illness. This scale categorizes barriers based on internal processes (e.g., cognitive skills, denial, pessimistic thinking) and contextual forces (e.g., illness-related factors, peer/family influences). Total summed scores were computed (range: 28-91). Higher scores indicate the high levels of perceived barriers to self-management.
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Illness Management Survey
|
56.74 units on a scale
Standard Deviation 16.95
|
64.61 units on a scale
Standard Deviation 13.11
|
60.55 units on a scale
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
This 13-item scale was designed to assess children's attitude toward their health condition. The scale includes questions such as "how good or bad do you feel it is that you have \_\_\_?" and, "how often do you feel that your \_\_\_ is your fault?" Respondents answer each question on a 5-point Likert-type scale (1-5). Total summed scores (range: 25-65) was constructed to reflect respondents' overall attitudes. Higher scores indicated positive attitudes.
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Attitude Toward Illness Scale
|
50.05 units on a scale
Standard Deviation 7.30
|
47.12 units on a scale
Standard Deviation 794
|
45.44 units on a scale
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
This 30-item instrument was developed to measure children's knowledge on triggers and symptom identifications, and asthma management procedures (i.e., what to do and how to do it) in a true/false format. Total scores (range: 14-30) were computed by summing the number of items correctly answered. The higher scores indicate greater knowledge levels.
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Asthma Knowledge Questionnaire
|
25.86 units on a scale
Standard Deviation 3.11
|
25.02 units on a scale
Standard Deviation 3.57
|
28.11 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 9 months post campPopulation: the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.
Maximal amount of air one can forcefully exhale in one second. It is then converted to a percentage of normal. Range: 55-124 for the current sample.
Outcome measures
| Measure |
Intervention Group
n=36 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=39 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) % Predicted
|
100.77 percentage of predicted FEV1
Standard Deviation 13.75
|
97.67 percentage of predicted FEV1
Standard Deviation 11.03
|
102.11 percentage of predicted FEV1
Standard Deviation 16.04
|
SECONDARY outcome
Timeframe: 9-months postcampPopulation: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.
Participants report the following information for the prior 3-month period; their emergency department visits for asthma; hospitalization for asthma; urgent office visit for worsening asthma; routine office visit; specialist visit. A cumulative number of events were computed by adding # of visits and # of days (for hospitalization) occurred in the past 3 months .
Outcome measures
| Measure |
Intervention Group
n=43 Participants
This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Control Group
n=41 Participants
This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
Peer Leader Group
n=9 Participants
Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
|
|---|---|---|---|
|
Health Care Utilization Events
|
0.53 average number of events
Standard Deviation 1.12
|
0.78 average number of events
Standard Deviation 1.27
|
0.77 average number of events
Standard Deviation 1.28
|
Adverse Events
Intervention Group
Control Group
Peer Leader 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