NCT05084976

Brief Summary

This study involves conducting a telephonic or in person survey regarding parental perception and attitudes about vaccinating the respective "technology dependent" child with the COVID 19 vaccination. "Technology dependent" includes tracheostomy dependence, artificial ventilator dependence and non invasive mechanical ventilation dependence. This population is vulnerable since most patients have underlying lung disease, chronic respiratory failure and require respiratory equipment to assist with breathing. "Technology dependent" patients are particularly vulnerable to respiratory infections and are considered high risk for developing severe COVID 19 illness. Despite this population's high risk for morbidity and mortality from respiratory viral infections, the investigator hypothesize that 50% of the parents are still vaccine hesitant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

October 18, 2021

Last Update Submit

July 15, 2022

Conditions

Chronic Respiratory FailureTracheostomy ComplicationMechanical Ventilation Complication

Keywords

Technology dependentTracheostomyMechanical ventilatorNon invasive mechanical ventilatorPediatric patientCOVID 19 vaccineVaccine hesitancy

Outcome Measures

Primary Outcomes (1)

  • Percentage of pediatric patient getting COVID 19 vaccine

    6 months after initial survey

Secondary Outcomes (4)

  • Percentage of mothers getting COVID 19 vaccine

    6 months after initial survey

  • Percentage of fathers getting COVID 19 vaccine

    6 months after initial survey

  • Percentage of other adults in household getting COVID 19 vaccine

    6 months after initial survey

  • Percentage of other eligible children in household getting COVID 19 vaccine

    6 months after initial survey

Study Arms (2)

Pediatric Technology Dependent Patients at Cohen Children's Medical Center

Behavioral: COVID 19 vaccine counseling

Pediatric Technology Dependent Patients at Ann & Robert H. Lurie Children's Hospital of Chicago

Behavioral: COVID 19 vaccine counseling

Interventions

COVID 19 vaccine counselingBEHAVIORAL

After surveys are completed, pulmonary provider (nurse practitioner or physician) will provide counseling via phone or in person about the COVID 19 vaccine. Safety, efficacy and side effects will be reviewed.

Pediatric Technology Dependent Patients at Ann & Robert H. Lurie Children's Hospital of ChicagoPediatric Technology Dependent Patients at Cohen Children's Medical Center

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Parents of technology dependent pediatric patients

You may qualify if:

  • Mother or father of child will be interviewed
  • Pediatric patient (age 0-21)
  • "Technology dependent" with one or more of the following: tracheostomy, ventilator use, non-invasive mechanical ventilator use (BiPAP, CPAP, Airvo), diaphragmatic pacing, oxygen

You may not qualify if:

  • Other caretakers such as grandparents, aunts, uncles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwell Health Physician Partners

Lake Success, New York, 11042, United States

Location

Related Publications (4)

  • Dosanjh A. Pediatric Vaccine Hesitancy and the Utilization of Antibody Measurements: A Novel Strategy with Implications for COVID 19. J Asthma Allergy. 2021 Apr 23;14:427-431. doi: 10.2147/JAA.S303309. eCollection 2021.

    PMID: 33935504BACKGROUND

  • Khubchandani J, Sharma S, Price JH, Wiblishauser MJ, Sharma M, Webb FJ. COVID-19 Vaccination Hesitancy in the United States: A Rapid National Assessment. J Community Health. 2021 Apr;46(2):270-277. doi: 10.1007/s10900-020-00958-x. Epub 2021 Jan 3.

    PMID: 33389421BACKGROUND

  • McAteer J, Yildirim I, Chahroudi A. The VACCINES Act: Deciphering Vaccine Hesitancy in the Time of COVID-19. Clin Infect Dis. 2020 Jul 28;71(15):703-705. doi: 10.1093/cid/ciaa433.

    PMID: 32282038BACKGROUND

  • Vasconcello-Castillo L, Torres-Castro R, Vera-Uribe R, Paiva R. COVID-19: Precautions with children in home mechanical ventilation. Pediatr Res. 2020 Oct;88(4):520-521. doi: 10.1038/s41390-020-1047-7. Epub 2020 Jul 2. No abstract available.

    PMID: 32615580BACKGROUND

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Karen Capusan, MSN

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 20, 2021

Study Start

September 23, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)