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Teen Asthma Project

Peer-Assisted Asthma Self-Management Program for Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01161225
Acronym
TAP
Enrollment
126
Registered
2010-07-13
Start date
2007-03-31
Completion date
2008-08-31
Last updated
2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Adolescents, Peer leader program, asthma camp, asthma control, quality of life, self-efficacy, knowledge, attitudes, barrier perceptions

Brief summary

Aims of this study are: 1. To determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma. 2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy, perception of barriers, and self-management behaviors, asthma control and quality of life over time among peer leaders. 3. To test the following hypothesis: * Adolescents participating in a peer-assisted asthma camp program will report improved knowledge, attitudes toward asthma, self-efficacy, and self-management behaviors, decreased perception of barriers, and increased asthma control and quality of life at 3-, 6- and 9-months post-intervention compared with the adult-led camp group. 4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic status, race, illness status, family support) on intervention outcomes such as self-management behaviors, asthma control and quality of life in adolescents with asthma. 5. To examine the effect of the peer-assisted camp program on self-reported health care utilization including emergency department visits, days of hospitalization, outpatient visits by comparing between baseline and 9-months post-camp data and between the peer-led camp and the adult-camp programs.

Interventions

BEHAVIORALPeer-assisted asthma self-management program

Intervention group: An asthma self-management program (Power Breathing™) was implemented by trained peer leaders at an asthma day camp. The program consisted of 3 sessions (appx. 45-60 min/session): basic asthma education (pathophysiology, triggers); psychosocial issues of asthma; and asthma self-management (peak flow monitoring and medication). The program was delivered by trained peer leaders paired for each small group of 6-8 teens. Group activities involved discussion, strategic thinking, knowledge-testing games and role plays.

BEHAVIORALAdult-led asthma self-management program

Control group: The group attended an adult-led day camp where 2 NPs and a MD offered didactic asthma education based on the Power Breathing™ program.

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
13 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

1. age between 13-18 years 2. mild, moderate or severe persistent asthma specified by the NHLBI Asthma guidelines 3. asthma diagnosis \> 1 year 4. no other major chronic/emotional health concerns 5. ability to understand spoken and written English. Participants were recruited from the communities through flyers, newspaper ads, and referrals from clinics and schools. Eligibility criteria for peer leaders included: 1. age between 16-20 years 2. nomination from school teachers/nurses or health care providers 3. average grade point B or above in the past school year 4. fulfillment of eligibility criteria (2)-(5) prescribed for adolescent participants.

Exclusion criteria

* learning disabilities based on reports from parents, teachers or clinicians

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)9 months post campTwenty-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)
Asthma Control Questions9 months post campThis 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.

Secondary

MeasureTime frameDescription
Attitude Toward Illness Scale9 months post campThis 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.
Asthma Knowledge Questionnaire9 months post campThis 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.
Asthma Self-Efficacy9 months post campThis 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.
Health Care Utilization Events9-months postcampParticipants 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 .
Forced Expiratory Volume in 1 Second (FEV1) % Predicted9 months post campMaximal 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.
Illness Management Survey9 months post campThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
59
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.
53
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.
14
Total126

Baseline characteristics

CharacteristicIntervention GroupControl GroupPeer Leader GroupTotal
Age, Continuous15.31 years
STANDARD_DEVIATION 1.36
14.97 years
STANDARD_DEVIATION 1.29
18.28 years
STANDARD_DEVIATION 1.9
15.50 years
STANDARD_DEVIATION 1.71
Region of Enrollment
United States
59 participants53 participants14 participants126 participants
Sex: Female, Male
Female
33 Participants31 Participants11 Participants75 Participants
Sex: Female, Male
Male
26 Participants22 Participants3 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 590 / 530 / 14
serious
Total, serious adverse events
0 / 590 / 530 / 14

Outcome results

Primary

Asthma Control Questions

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupAsthma Control Questions14.84 units on a scaleStandard Deviation 1.86
Control GroupAsthma Control Questions14.19 units on a scaleStandard Deviation 1.83
Peer Leader GroupAsthma Control Questions14.89 units on a scaleStandard Deviation 1.05
Primary

Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

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)

Time frame: 9 months post camp

Population: The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupPediatric Asthma Quality of Life Questionnaire (PAQLQ)140.30 units on a scaleStandard Deviation 21.04
Control GroupPediatric Asthma Quality of Life Questionnaire (PAQLQ)125.12 units on a scaleStandard Deviation 25.95
Peer Leader GroupPediatric Asthma Quality of Life Questionnaire (PAQLQ)138.11 units on a scaleStandard Deviation 16.44
Secondary

Asthma Knowledge Questionnaire

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupAsthma Knowledge Questionnaire25.86 units on a scaleStandard Deviation 3.11
Control GroupAsthma Knowledge Questionnaire25.02 units on a scaleStandard Deviation 3.57
Peer Leader GroupAsthma Knowledge Questionnaire28.11 units on a scaleStandard Deviation 1.45
Secondary

Asthma Self-Efficacy

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupAsthma Self-Efficacy56.19 units on a scaleStandard Deviation 10.02
Control GroupAsthma Self-Efficacy51.93 units on a scaleStandard Deviation 9.09
Peer Leader GroupAsthma Self-Efficacy57.44 units on a scaleStandard Deviation 3.84
Secondary

Attitude Toward Illness Scale

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupAttitude Toward Illness Scale50.05 units on a scaleStandard Deviation 7.3
Control GroupAttitude Toward Illness Scale47.12 units on a scaleStandard Deviation 794
Peer Leader GroupAttitude Toward Illness Scale45.44 units on a scaleStandard Deviation 5.9
Secondary

Forced Expiratory Volume in 1 Second (FEV1) % Predicted

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupForced Expiratory Volume in 1 Second (FEV1) % Predicted100.77 percentage of predicted FEV1Standard Deviation 13.75
Control GroupForced Expiratory Volume in 1 Second (FEV1) % Predicted97.67 percentage of predicted FEV1Standard Deviation 11.03
Peer Leader GroupForced Expiratory Volume in 1 Second (FEV1) % Predicted102.11 percentage of predicted FEV1Standard Deviation 16.04
Secondary

Health Care Utilization Events

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 .

Time frame: 9-months postcamp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupHealth Care Utilization Events0.53 average number of eventsStandard Deviation 1.12
Control GroupHealth Care Utilization Events0.78 average number of eventsStandard Deviation 1.27
Peer Leader GroupHealth Care Utilization Events0.77 average number of eventsStandard Deviation 1.28
Secondary

Illness Management Survey

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.

Time frame: 9 months post camp

Population: the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupIllness Management Survey56.74 units on a scaleStandard Deviation 16.95
Control GroupIllness Management Survey64.61 units on a scaleStandard Deviation 13.11
Peer Leader GroupIllness Management Survey60.55 units on a scaleStandard Deviation 10.31

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026