Phase 2
N=371
Peer Led Asthma Self Management for Adolescents: PLASMA
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02293499 ↗Enrolled (actual)
371
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: The Pediatric Asthma Quality of Life Questionnaire (PAQOL) — 5.58; 5.93; 6.49 score on a scale — p=.043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PLASMA (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Pediatric Asthma Quality of Life Questionnaire (PAQOL) |
5.58; 5.93; 6.49 | .043 sig |
| SECONDARY Adolescent Asthma Knowledge Questionnaire (AAK) |
23.07; 23.53; 25.85 | 0.295 |
| SECONDARY Attitude Toward Asthma Scale (ATA) |
3.58; 3.77; 3.95 | .140 |
| SECONDARY Asthma Self-Efficacy (ASE) |
56.38; 58.36; 63.62 | .268 |
| SECONDARY Asthma Outcome Expectation Scale (AOE) |
5.87; 6; 6.27 | .238 |
| SECONDARY Asthma Prevention Index |
2.20; 2.11; 2.18 | .484 |
| SECONDARY Asthma Management Index (AMI) |
5.51; 5.67; 5.04 | .648 |
| SECONDARY Asthma Management Self-efficacy Index |
4.79; 4.96; 5.40 | .020 sig |
| SECONDARY Asthma Control Questionnaire (ACQ) |
1.15; 0.92; 0.44 | .049 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02293499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.