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NCT02293499 · ClinicalTrials.gov registry record · Phase 2
Peer Led Asthma Self Management for Adolescents: PLASMA
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 371
- Enrollment target
NCT02293499 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 371 participants.
The verdict
NCT02293499, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 371 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL PLASMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2015-05-14 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02293499
The ClinicalTrials.gov registry entry for NCT02293499 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 371 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PLASMA is the first listed.
NCT02293499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02293499 about?
NCT02293499 is a clinical study titled "Peer Led Asthma Self Management for Adolescents: PLASMA". 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 individ...
What is the current status of trial NCT02293499?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 371 participants. The study started on 2015-05-14. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT02293499?
The interventions under investigation include: PLASMA (BEHAVIORAL).
Who is sponsoring clinical trial NCT02293499?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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