Teen Asthma Project

Asthma Clinical Trial

— TAP  

Official title:

Peer-Assisted Asthma Self-Management Program for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161225
• Other study ID #: R21NR009837
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: December 9, 2014
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: December 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Peer-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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	9 months post camp	No
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.	9 months post camp	No
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.	9 months post camp	No
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.	9 months post camp	No
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.	9 months post camp	No
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.	9 months post camp	No
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.	9 months post camp	No
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 .	9-months postcamp	No