Asthma
Conditions
Keywords
Asthma
Brief summary
The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.
Interventions
BEHAVIORALIntervention
Teens participating in this study will have: 1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study 2. three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications).
Sponsors
National Institutes of Health (NIH)
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma * Persistent asthma (criteria based on NHLBI guidelines). * Age \>12 and \<15 years. * Attending school in the Rochester City School District. * Signed physician permission to enroll the child. * Current prescription of a daily preventive asthma medication * Parent or caregiver and the adolescent must consent to the intervention.
Exclusion criteria
* Inability to speak and understand English. * No access to a working phone for follow-up surveys * The family planning to leave the school district within fewer than 6 months. * The teen having other significant medical conditions * The teen having a diagnosed developmental condition per parent report. * Adolescents in foster care or other situations in which consent cannot be obtained from a guardian. * Adolescents that were previously enrolled in our School-Based Asthma Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptom-free Days Over Two Weeks | 2 and 4 month follow-up assessments | We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Asthma Morbidity Measures | 2 month, 4 month, final follow-up assessments | We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Teens participating in this study will have:
1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
2. three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 13.6 years STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Symptom-free Days Over Two Weeks
We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.
Time frame: 2 and 4 month follow-up assessments
Population: Analysis conducted per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Number of Symptom-free Days Over Two Weeks | 10.79 Days | Standard Deviation 3.74 |
| Two Months Post Baseline | Number of Symptom-free Days Over Two Weeks | 8.71 Days | Standard Deviation 4.66 |
| Four Months Post Baseline | Number of Symptom-free Days Over Two Weeks | 12.89 Days | Standard Deviation 1.62 |
Secondary
Additional Asthma Morbidity Measures
We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.
Time frame: 2 month, 4 month, final follow-up assessments