AsthmaTAPNCT01161225
Teen Asthma Project
A study testing Peer-assisted asthma self-management program and Adult-led asthma self-management program in people with Asthma, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Asthma
- What is being tested?
- Peer-assisted asthma self-management program and Adult-led asthma self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age between 13-18 years
- mild, moderate or severe persistent asthma specified by the NHLBI Asthma guidelines
- asthma diagnosis > 1 year
- no other major chronic/emotional health concerns
- 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:
Show all 10Show fewer
- age between 16-20 years
- nomination from school teachers/nurses or health care providers
- average grade point B or above in the past school year
- fulfillment of eligibility criteria (2)-(5) prescribed for adolescent participants.
Who cannot join
- learning disabilities based on reports from parents, teachers or clinicians
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Peer-Assisted Asthma Self-Management Program for Adolescents
Aims of this study are:
- To determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma.
- 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.
- To test the following hypothesis:
Read more
- 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.
- 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.
- 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.
- Conditions
- Asthma
- Being tested
- Peer-assisted asthma self-management program, Adult-led asthma self-management program
- Keywords
- Adolescents, Peer leader program, asthma camp, asthma control, quality of life, self-efficacy, knowledge, attitudes, barrier perceptions
- Medical subject headings
- Asthma, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-assisted asthma self-management programBehavioural
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.
Adult-led asthma self-management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| peer-led asthma self-managment program | Experimental | Not described Receives: Behavioral: Peer-assisted asthma self-management program |
| Adult-led asthma self-management program | Active comparator | Not described Receives: Behavioral: Adult-led asthma self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 9 months post camp
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.
Measured: 9 months post camp
Secondary outcomes (6)
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.
Measured: 9 months post camp
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.
Measured: 9 months post camp
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.
Measured: 9 months post camp
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.
Measured: 9 months post camp
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.
Measured: 9 months post camp
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 .
Measured: 9-months postcamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyekyun Rhee, University of Rochester
- Investigators
- Hyekyun Rhee, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161225
- Sponsor's protocol ID
- R21NR009837
- Acronym
- TAP
- Status last verified
- Dec 2014
- First submitted
- 9 Jul 2010
- Last updated
- 15 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rhee H, Ciurzynski SM, Yoos HL. Pearls and pitfalls of community-based group interventions for adolescents: lessons learned from an adolescent asthma cAMP study. Issues Compr Pediatr Nurs. 2008 Jul-Sep;31(3):122-35. doi: 10.1080/01460860802272888.
PubMed 18728958Rhee H, Belyea MJ, Ciurzynski S, Brasch J. Barriers to asthma self-management in adolescents: Relationships to psychosocial factors. Pediatr Pulmonol. 2009 Feb;44(2):183-91. doi: 10.1002/ppul.20972.
PubMed 19142893Rhee H, Belyea MJ, Elward KS. Patterns of asthma control perception in adolescents: associations with psychosocial functioning. J Asthma. 2008 Sep;45(7):600-6. doi: 10.1080/02770900802126974.
PubMed 18773334Rhee H, McQuillan BE, Belyea MJ. Evaluation of a peer-led asthma self-management program and benefits of the program for adolescent peer leaders. Respir Care. 2012 Dec;57(12):2082-9. doi: 10.4187/respcare.01488.
PubMed 22710616Rhee H, Pesis-Katz I, Xing J. Cost benefits of a peer-led asthma self-management program for adolescents. J Asthma. 2012 Aug;49(6):606-13. doi: 10.3109/02770903.2012.694540. Epub 2012 Jul 4.
PubMed 22758599Rhee H, Belyea MJ, Hunt JF, Brasch J. Effects of a peer-led asthma self-management program for adolescents. Arch Pediatr Adolesc Med. 2011 Jun;165(6):513-9. doi: 10.1001/archpediatrics.2011.79.
PubMed 21646583Rhee H, Belyea MJ, Halterman JS. Adolescents' perception of asthma symptoms and health care utilization. J Pediatr Health Care. 2011 Mar-Apr;25(2):105-13. doi: 10.1016/j.pedhc.2009.10.003.
PubMed 21320682
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Assisted Asthma Self-Management Program for Adolescents
- ClinicalTrials.gov ID
- NCT01161225
- Acronym / sponsor ID
- TAP / R21NR009837
- Conditions
- Asthma
- Keywords
- Adolescents, Peer leader program, asthma camp, asthma control, quality of life, self-efficacy, knowledge, attitudes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims of this study are:
- To determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peer-led asthma self-managment program | Experimental | Behavioral: Peer-assisted asthma self-management program |
| Adult-led asthma self-management program | Active comparator | Behavioral: Adult-led asthma self-management program |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- age between 13-18 years
- mild, moderate or severe persistent asthma specified by the NHLBI Asthma guidelines
- asthma diagnosis > 1 year
- no other major chronic/emotional health concerns
- ability to understand spoken and written English. Participants were recruited from the communities through flyers, newspaper ads, and referrals from clinics and schools.
Key exclusion criteria (1 listed)
- learning disabilities based on reports from parents, teachers or clinicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-assisted asthma self-management programIntervention 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. | Behavioural | peer-led asthma self-managment program |
| Adult-led asthma self-management programControl 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. | Behavioural | Adult-led asthma self-management program |
Primary outcome
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: 9 months post camp
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)
Asthma Control Questions
Time frame: 9 months post camp
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.
6 secondary outcomes
Asthma Self-Efficacy
Time frame: 9 months post camp
Illness Management Survey
Time frame: 9 months post camp
Attitude Toward Illness Scale
Time frame: 9 months post camp
Asthma Knowledge Questionnaire
Time frame: 9 months post camp
Forced Expiratory Volume in 1 Second (FEV1) % Predicted
Time frame: 9 months post camp
Health Care Utilization Events
Time frame: 9-months postcamp
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18728958Rhee H, Ciurzynski SM, Yoos HL. Pearls and pitfalls of community-based group interventions for adolescents: lessons learned from an adolescent asthma cAMP study. Issues Compr Pediatr Nurs. 2008 Jul-Sep;31(3):122-35. doi: 10.1080/01460860802272888.
- Results publication: PubMed 19142893Rhee H, Belyea MJ, Ciurzynski S, Brasch J. Barriers to asthma self-management in adolescents: Relationships to psychosocial factors. Pediatr Pulmonol. 2009 Feb;44(2):183-91. doi: 10.1002/ppul.20972.
- Results publication: PubMed 18773334Rhee H, Belyea MJ, Elward KS. Patterns of asthma control perception in adolescents: associations with psychosocial functioning. J Asthma. 2008 Sep;45(7):600-6. doi: 10.1080/02770900802126974.
- Results publication: PubMed 22710616Rhee H, McQuillan BE, Belyea MJ. Evaluation of a peer-led asthma self-management program and benefits of the program for adolescent peer leaders. Respir Care. 2012 Dec;57(12):2082-9. doi: 10.4187/respcare.01488.
- Results publication: PubMed 22758599Rhee H, Pesis-Katz I, Xing J. Cost benefits of a peer-led asthma self-management program for adolescents. J Asthma. 2012 Aug;49(6):606-13. doi: 10.3109/02770903.2012.694540. Epub 2012 Jul 4.
- Results publication: PubMed 21646583Rhee H, Belyea MJ, Hunt JF, Brasch J. Effects of a peer-led asthma self-management program for adolescents. Arch Pediatr Adolesc Med. 2011 Jun;165(6):513-9. doi: 10.1001/archpediatrics.2011.79.
- Results publication: PubMed 21320682Rhee H, Belyea MJ, Halterman JS. Adolescents' perception of asthma symptoms and health care utilization. J Pediatr Health Care. 2011 Mar-Apr;25(2):105-13. doi: 10.1016/j.pedhc.2009.10.003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyekyun Rhee, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-assisted asthma self-management program and Adult-led asthma self-management program in people with Asthma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) (time frame: 9 months post camp). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161225, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014; AzTrials last refreshed its copy on 27 Oct 2026.