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Teen Asthma Project (TAP)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-assisted asthma self-management program
Adult-led asthma self-management program
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Adolescents, Peer leader program, asthma camp, asthma control, quality of life, self-efficacy, knowledge, attitudes, barrier perceptions

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

peer-led asthma self-managment program

Adult-led asthma self-management program

Arm Description

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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 .

Full Information

First Posted
July 9, 2010
Last Updated
December 9, 2014
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01161225
Brief Title
Teen Asthma Project
Acronym
TAP
Official Title
Peer-Assisted Asthma Self-Management Program for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adolescents, Peer leader program, asthma camp, asthma control, quality of life, self-efficacy, knowledge, attitudes, barrier perceptions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
peer-led asthma self-managment program
Arm Type
Experimental
Arm Title
Adult-led asthma self-management program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Peer-assisted asthma self-management program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adult-led asthma self-management program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Description
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
Title
Asthma Control Questions
Description
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
Secondary Outcome Measure Information:
Title
Asthma Self-Efficacy
Description
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
Title
Illness Management Survey
Description
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
Title
Attitude Toward Illness Scale
Description
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
Title
Asthma Knowledge Questionnaire
Description
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
Title
Forced Expiratory Volume in 1 Second (FEV1) % Predicted
Description
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
Title
Health Care Utilization Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyekyun Rhee, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18728958
Citation
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.
Results Reference
background
PubMed Identifier
19142893
Citation
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.
Results Reference
result
PubMed Identifier
18773334
Citation
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.
Results Reference
result
PubMed Identifier
22710616
Citation
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.
Results Reference
result
PubMed Identifier
22758599
Citation
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.
Results Reference
result
PubMed Identifier
21646583
Citation
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.
Results Reference
result
PubMed Identifier
21320682
Citation
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.
Results Reference
result

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Teen Asthma Project

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