- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161225
Teen Asthma Project (TAP)
December 9, 2014 updated by: Hyekyun Rhee, University of Rochester
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:
- 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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- learning disabilities based on reports from parents, teachers or clinicians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: peer-led asthma self-managment 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.
|
Active Comparator: Adult-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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
9 months post camp
|
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.
|
9 months post camp
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Self-Efficacy
Time Frame: 9 months post camp
|
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.
|
9 months post camp
|
Illness Management Survey
Time Frame: 9 months post camp
|
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.
|
9 months post camp
|
Attitude Toward Illness Scale
Time Frame: 9 months post camp
|
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.
|
9 months post camp
|
Asthma Knowledge Questionnaire
Time Frame: 9 months post camp
|
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.
|
9 months post camp
|
Forced Expiratory Volume in 1 Second (FEV1) % Predicted
Time Frame: 9 months post camp
|
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.
|
9 months post camp
|
Health Care Utilization Events
Time Frame: 9-months postcamp
|
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 .
|
9-months postcamp
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyekyun Rhee, PhD, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Rhee 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.
- Rhee 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.
- Rhee 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.
- Rhee 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.
- Rhee 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.
- Rhee 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
July 9, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Estimate)
December 15, 2014
Last Update Submitted That Met QC Criteria
December 9, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21NR009837 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Peer-assisted asthma self-management program
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
China Medical University HospitalMinistry of Health and Welfare, TaiwanUnknownChronic Kidney Diseases | Chronic Kidney InsufficiencyTaiwan
-
Restech SrlRecruitingAsthmaItaly, Australia, France
-
Institute of Liver and Biliary Sciences, IndiaCompleted
-
Hospital for Special Surgery, New YorkCompletedDepression | Asthma | AnxietyUnited States
-
The University of Texas Health Science Center at...National Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | Asthma
-
University of WashingtonCompletedSpinal Cord InjuriesUnited States
-
The University Clinic of Pulmonary and Allergic...University of PrimorskaCompleted
-
University of MichiganRecruiting
-
Johns Hopkins UniversityCompleted