Peer Led Asthma Self Management for Adolescents: PLASMA

NCT02293499 | Completed Phase 2 Results DMC

• 1 other identifier: RSRB00053987
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 4

Brief Summary

Asthma is a serious chronic health condition particularly in inner-city adolescents, who suffer disproportionately high asthma-related morbidity and mortality that place heavy economic burdens on families and society. There is a consensus that adverse asthma outcomes can be ameliorated by an individual's active engagement in adequate self-management. This multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma self-management for adolescents (PLASMA) program that has demonstrated its feasibility and preliminary efficacy in a previous study. PLASMA will be implemented in three cities (Buffalo NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma and asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA comprises three main components: (a) peer-leader training; (b) a one-day asthma camp where peer leaders will deliver manualized self-management content recommended by the national guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate the effectiveness of PLASMA in inner-city adolescents with asthma in improving quality of life (primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy, self-management skills, and asthma control, FEV1 (exploratory outcomes) over time, compared to a control group for whom adult leaders will deliver the same program content; (2) to examine the mediating effects of the exploratory outcomes on quality of life; (3) to examine the moderating effects of personal factors (e.g., age, sex, family support) on the intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA on study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact of the intervention. These aims will be accomplished using a two-group randomized controlled trial with 378 adolescents (12-17 years) from the three cities (126 for each site). A total of 42 qualified peer leaders (14 in each site) will be enrolled based on adult nomination. Eligibility criteria for both peer leaders and adolescent learners include: a current asthma diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city residence; and capability of verbal and written communication in English. Participants will provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months post-camp (T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear mixed-effects model where level 1 represents repeated measures, level 2 = subject, and level 3 = site. To determine the economic impact of the program, investigator will measure the direct healthcare costs and total costs of the program, and perform net cost analyses for each type of costs. In addition, investigator will estimate cost-effectiveness ratios of the PLASMA group compared with the control.

Conditions

Asthma

Keywords

asthma; adolescent; intervention

Outcome Measures

Primary Outcomes (1)

• The Pediatric Asthma Quality of Life Questionnaire (PAQOL)

  a 23-item instrument, 118 consists of three subdomains: activity limitation (5 items), emotional function (8 items), and symptoms (10 items). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life.

  15 months

Secondary Outcomes (8)

• Adolescent Asthma Knowledge Questionnaire (AAK)

  15 months

• Attitude Toward Asthma Scale (ATA)

  15 months

• Asthma Self-Efficacy (ASE)

  15 months

• Asthma Outcome Expectation Scale (AOE)

  15 months

• Asthma Prevention Index

  15 months

Study Arms (2)

Peer Led Asthma Self-Management

ACTIVE COMPARATOR

Peer-led asthma self-management for adolescents : PLASMA will be implemented in small groups at a camp setting where paired peer-leaders will facilitate learning activities.Paired peer leaders will share and coordinate the responsibilities of facilitating group activities. Training content includes: Day 1: Asthma basics and prevention; Day 2: Asthma monitoring and management; Day 3: Communication/ psychosocial issue management/leadership training/hands-on practice in simulated peer-led group settings (role-play)

Behavioral: PLASMA

Adult Led Asthma Self-Management

ACTIVE COMPARATOR

The adult led asthma self-management will take place within 2 weeks of the peer-led camp to minimize the history effect. Two healthcare professionals will attend peer-leader training sessions to become familiar with the program content, then lead instructional activities. As in PLASMA, adult leaders will base their instruction on the program manual to ensure comparable program content. Adult leaders will adopt mainly a didactic format and skill demonstration.

Behavioral: PLASMA

Interventions

PLASMA BEHAVIORAL

A structured asthma self-management manual ("Let's Talk about Asthma \[LTAA\],"developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. Group learning activities will closely align with the program manual (LTAA) that consists of three sessions. Participants will also learn and practice skills in using the peak flow meter, spacer and inhaler, daily symptom diary and asthma action plan. Besides instructional activities, participants will engage in recreational activities that each camp site.

Adult Led Asthma Self-Management; Peer Led Asthma Self-Management

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligibility criteria for adolescent (camp) participants include:
• age between 12-17 years;
• physician-diagnosed asthma that has required health service use (preventive or acute) within 12 months prior to recruitment;
• persistent asthma determined by current use of a control medication or presenting at least one of the following four symptom levels in the past 4 weeks, as defined by the NAEPP guidelines91:
• \> 2 days/week of daytime symptoms,
• \>3-4 times of nighttime awakening,
• \>2 days/week of SABA use, or
• any interference with normal activities due to asthma (4) Investigators will include those with chronic health conditions except for those with conditions affecting respiratory system, heart disease, pneumonia, etc., and those with moderate to severe cognitive impairments; (5) primary residence located in the participating inner cities based on zip codes; and (6) ability to understand spoken and written English.
• Eligibility criteria for peer leaders include:
• age between 16-20 years;
• nomination from school teachers/nurses or healthcare providers for candidates' exemplary asthma self-management, leadership, and emotional intelligence; and
• fulfillment of eligibility criteria (2)-(6) prescribed for adolescent participants.

You may not qualify if:

• Adolescents who are pregnant or incarcerated at enrollment;
• Have learning disabilities based on reports from teachers or clinicians will be excluded from the study because such conditions can confound the interpretation of findings;
• Those who have serious health (other than asthma) and emotional preconditions (e.g., severe depression, anxiety disorders, schizophrenia).

Sponsors & Collaborators

• University of Rochester: lead
• Johns Hopkins University: collaborator
• University of Tennessee: collaborator

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Related Publications (3)

• Rhee H, Love T, Wicks MN, Tumiel-Berhalter L, Sloand E, Harrington D, Walters L. Long-term Effectiveness of a Peer-Led Asthma Self-management Program on Asthma Outcomes in Adolescents Living in Urban Areas: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2137492. doi: 10.1001/jamanetworkopen.2021.37492.

  PMID: 34874404 DERIVED

• Rhee H, Love T, Mammen J. Comparing Asthma Control Questionnaire (ACQ) and National Asthma Education and Prevention Program (NAEPP) asthma control criteria. Ann Allergy Asthma Immunol. 2019 Jan;122(1):58-64. doi: 10.1016/j.anai.2018.09.448. Epub 2018 Sep 11.

  PMID: 30213611 DERIVED

• Rhee H, Love TM, Harrington D, Grape A. Comorbidity of atopy in urban adolescents with asthma. Ann Allergy Asthma Immunol. 2017 Nov;119(5):466-467. doi: 10.1016/j.anai.2017.08.017. No abstract available.

  PMID: 29150074 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Hyekyun Rhee PhD, RN, FAAN
• Organization: University of Rochester School of Nursing

Hyekyun_Rhee@urmc.rochester.edu

585-276-3775

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the overt nature of the intervention, blinding either participants or investigators was not achieved although we did not inform participants of their group membership explicitly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: November 18, 2014
• Study Start: May 14, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Locations

US (4)