Evaluation of a Remote Asthma Monitoring Program to Improve Health Outcomes in Pediatric Asthma

NCT05139485 | Terminated

• 1 other identifier: 20-06022311
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this pilot study to is to determine the overall impact of a clinical program of remote medication monitoring administered by St. Mary's Homecare on disease control in pediatric asthma patients. The central hypothesis is that a short-term program of remote asthma medication monitoring paired with home visits and asthma education will be associated with a sustained improvement in asthma symptom control in children over time.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Change in asthma control test (ACT) scores

  This outcome will compare ACT scores at the time of enrollment, to month 6 and month 12 scores

  Baseline (enrollment), Month 6 and Month12

Secondary Outcomes (7)

• Change in percent of Controller Medication administered

  3 months, 6 months and 12months

• Change in number of Rescue Medication doses administered

  3 months, 6 months and 12months

• Change in health-care use: Number of physician visits

  Enrollment, Month 12

• Change in health-care use: Number of Emergency Department (ED) visits

  Enrollment, Month 12

• Change in health-care use: Number of Hospitalizations

  Enrollment, Month 12

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects between the ages of 3 and 21 years who have a diagnosis of persistent asthma (mild, moderate or severe) who have poorly controlled symptoms

You may qualify if:

• Age 3- 21 years
• Diagnosis of persistent asthma (mild, moderate, severe) previously diagnosed by a physician
• Diagnosis of poorly controlled asthma or and asthma control test (ACT) score of \<19

You may not qualify if:

• Patients who have severe cognitive delay, significant mental illness which impairs daily functioning or are non-verbal will be excluded as they are less likely to benefit from the educational techniques administered
• Primary language other than English or Spanish

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Study Officials

• Jennie Ono, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: June 10, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)