Trial Outcomes & Findings for Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools (NCT NCT02735174)

Last Updated: 2020-10-19

Results Overview

Change in composite asthma severity index score (Baseline CASI score-6 month CASI score). A positive score indicates a better outcome. \[The CASI score has a minimum value = 0, maximum value = 20\]. The rows represent the change from baseline in scores in all subjects and subsets of participants who obtained "CASI \>=4 at baseline and "CASI \<4" at baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Asthma Self-management Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Asthma Self-management n=21 Participants Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control.
Age, Categorical <=18 years	21 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	13.67 years STANDARD_DEVIATION 2.46 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Baseline CASI score	4.67 score on a scale STANDARD_DEVIATION 3.07 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: 21 participants were analyzed for the CASI score all participants value. Participants were grouped in two categories. 11 participants with baseline CASI \>=4 were analyzed independently for the CASI score \>=4 at Baseline Value. 10 participants with baseline CASI \<4 were also analyzed independently for the CASI score \<4 at Baseline Value.

Outcome measures

Outcome measures
Measure	Single Arm Asthma Self-management n=21 Participants Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control.
Change in Composite Asthma Severity Index (CASI) Score Change in CASI score all participants	0.14 Change in score on a scale Standard Deviation 2.90
Change in Composite Asthma Severity Index (CASI) Score Change in CASI score >=4 at Baseline	2.4 Change in score on a scale Standard Deviation 2.50
Change in Composite Asthma Severity Index (CASI) Score Change in CASI score <4 at Baseline	-1.91 Change in score on a scale Standard Deviation 1.22

Adverse Events

Single Arm Asthma Self-management

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

Theresa Guilbert, MD, MS

Cincinnati Children's Hospital Medical Center

Phone: (513) 636-6771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place