Trial Outcomes & Findings for A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents (NCT NCT01106326)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

2 and 4 month follow-up assessments

Results posted on

2014-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=30 Participants 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).
Age, Categorical <=18 years	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	13.6 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 and 4 month follow-up assessments

Population: Analysis conducted per protocol.

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.

Outcome measures

Outcome measures
Measure	Baseline n=30 Participants	Two Months Post Baseline n=28 Participants	Four Months Post Baseline n=28 Participants
Number of Symptom-free Days Over Two Weeks	10.79 Days Standard Deviation 3.74	8.71 Days Standard Deviation 4.66	12.89 Days Standard Deviation 1.62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Fagnano

University of Rochester

Phone: 5852758220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place