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

NCT02735174 | Completed Results

• 1 other identifier: CIN001_AFS4
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to improve the partnership between Cincinnati Children's Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this project "asthma-free schools" and bringing it to neighborhoods where the incidence of asthma is especially high. We have designed this study to work with school-based asthma care programs. Children with high-risk asthma will be asked to participate. "High-risk" will be defined as poorly controlled asthma, frequent school absences, and/or need for daily controller asthma medications. We will use a commercially available inhaler cap sensor to help track medication use and symptoms through a smartphone. The study visits will be done mostly at the school using telehealth technology similar to Skype.

Conditions

Asthma

Keywords

Telehealth; Sensor cap; School based care; Community health; AsthmaTreatSmart Application

Outcome Measures

Primary Outcomes (1)

• Change in Composite Asthma Severity Index (CASI) Score

  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.

  Baseline to 6 months

Study Arms (1)

Single arm asthma self-management

EXPERIMENTAL

Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits

Device: Sensor cap system for inhalers; Other: App for SmartPhone; Behavioral: Motivational interviews; Other: Telehealth clinic visits

Interventions

Sensor cap system for inhalers DEVICE

All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.

Also known as: Propeller

Single arm asthma self-management

App for SmartPhone OTHER

All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.

Single arm asthma self-management

Motivational interviews BEHAVIORAL

All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills

Single arm asthma self-management

Telehealth clinic visits OTHER

All subjects will have asthma medical visits via telehealth technology to assess asthma control.

Single arm asthma self-management

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• history of provider diagnosed asthma
• history of uncontrolled asthma in the past 12 months as measured by two asthma control Test (ACT) scores less than 20; or more than or equal to 1 emergency room visit or hospitalization for asthma; or more than or equal to 2 prednisone bursts with current persistent asthma as defined by National Asthma Education and Prevention Program (NAEPP) guidelines
• attendance at participating school

You may not qualify if:

• active chronic disease apart from asthma or allergic disease
• plans to change schools during the school year

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Verizon Foundation: collaborator
• Luther Foundation: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Nebulizers and Vaporizers; Amyloid

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Theresa Guilbert, MD, MS
• Organization: Cincinnati Children's Hospital Medical Center

Theresa.Guilbert@cchmc.org

(513) 636-6771

Study Officials

• Theresa Guilbert, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor Division of Pulmonary Medicine

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: April 12, 2016
• Study Start: January 1, 2016
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)