Chronic Respiratory FailureNCT05084976
Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
An observational study of Chronic Respiratory Failure and Tracheostomy Complication, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Chronic Respiratory Failure, Tracheostomy Complication, Mechanical Ventilation Complication
- What is being tested?
- COVID 19 vaccine counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Parents of technology dependent pediatric patients
Who may be able to join
- 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
Who cannot join
- Other caretakers such as grandparents, aunts, uncles
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Physician Partners
Lake Success, New York, 11042
About this study
Official title: Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence
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.
Read the detailed description
Vaccinating the population is the next step in combating COVID 19 pandemic however there continues to be vaccine hesitancy. Vaccine hesitancy is the indecision of consenting to vaccination (Dosanjh, 2021) and is not a new phenomenon. The most recent example is the reemergence of measles in the United States prior to the COVID 19 pandemic. Anti-vaccine groups have spread messages of conspiracy theories, myths and misperceptions, questions about the speed of vaccine development and long term side effects in the media which also attributes to COVID-19 vaccine hesitancy (Khubcandani et al, 2021).
Children infected with COVID 19 typically have mild symptoms of the disease. Risk factors associated with severe disease are neonatal age group, male gender, lower respiratory tract disease and pre-existing medical conditions. Children who use chronic home mechanical ventilation are considered a high-risk group for developing severe COVID 19 infection (Vasconcello-Castillo et al., 2020). These children have various diagnoses and pathologies such as neuromuscular disease, sleep disorders and chronic lung disease. These patients require continuous use of ventilatory support in the home and are at high risk for respiratory infections and mortality. Most of these patients need advanced nursing care and special respiratory equipment to prevent hospitalization such as manual chest physiotherapy, mechanical ex-sufflator device, chest vest device and increased ventilator support.
Recently the FDA approved of Pfizer's COVID 19 vaccine in ages 12 and older. It is anticipated that by fall 2021 the Pfizer COVID 19 vaccine will be approved by the FDA for children ages 2 and older. Vaccinating children will help decrease transmission of COVID 19, contribute to community immunity and allow kids go back to camps this summer and back to in-person school more safely.
Since the chronic home mechanical ventilation population is at risk for developing severe COVID 19 disease, the investigator would hypothesize that most parents are ready and willing to vaccinate their children. The purpose of this study is to evaluate the parental perception of COVID 19 vaccine in pediatric patients with "technology dependence" and identify the barriers to vaccination.
After surveys are collected and barriers are identified, vaccine counseling will be provided by a provider (nurse practitioner or physician). Vaccine safety, efficacy, side effects will be reviewed with the parents.
- Conditions
- Chronic Respiratory Failure, Tracheostomy Complication, Mechanical Ventilation Complication
- Being tested
- COVID 19 vaccine counseling
- Keywords
- Technology dependent, Tracheostomy, Mechanical ventilator, Non invasive mechanical ventilator, Pediatric patient, COVID 19 vaccine, Vaccine hesitancy
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID 19 vaccine counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Technology Dependent Patients at Cohen Children's Medical Center | Not described Receives: Behavioral: COVID 19 vaccine counseling | |
| Pediatric Technology Dependent Patients at Ann & Robert H. Lurie Children's Hospital of Chicago | Not described Receives: Behavioral: COVID 19 vaccine counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pediatric patient getting COVID 19 vaccine
Measured: 6 months after initial survey
Secondary outcomes (4)
Percentage of mothers getting COVID 19 vaccine
Measured: 6 months after initial survey
Percentage of fathers getting COVID 19 vaccine
Measured: 6 months after initial survey
Percentage of other adults in household getting COVID 19 vaccine
Measured: 6 months after initial survey
Percentage of other eligible children in household getting COVID 19 vaccine
Measured: 6 months after initial survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start23 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Capusan, MSN, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084976
- Sponsor's protocol ID
- 21-0822
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33935504Khubchandani 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.
PubMed 33389421McAteer 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.
PubMed 32282038Vasconcello-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.
PubMed 32615580
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence
- ClinicalTrials.gov ID
- NCT05084976
- Acronym / sponsor ID
- 21-0822
- Conditions
- Chronic Respiratory Failure, Tracheostomy Complication, Mechanical Ventilation Complication
- Keywords
- Technology dependent, Tracheostomy, Mechanical ventilator, Non invasive mechanical ventilator, Pediatric patient, COVID 19 vaccine, Vaccine hesitancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vaccinating the population is the next step in combating COVID 19 pandemic however there continues to be vaccine hesitancy. Vaccine hesitancy is the indecision of consenting to vaccination (Dosanjh, 2021) and is not a new phenomenon. The most recent example is the reemergence of measles in the United States prior to the COVID 19 pandemic. Anti-vaccine groups have spread messages of conspiracy theories, myths and misperceptions, questions about the speed of vaccine development and long term side effects in the media which also attributes to COVID-19 vaccine hesitancy (Khubcandani et al, 2021).
Children infected with COVID 19 typically have mild symptoms of the disease. Risk factors associated with severe disease are neonatal age group, male gender, lower respiratory tract disease and pre-existing medical conditions. Children who use chronic home mechanical ventilation are considered a high-risk group for developing severe COVID 19 infection (Vasconcello-Castillo et al., 2020). These children have various diagnoses and pathologies such as neuromuscular disease, sleep disorders and chronic lung disease. These patients require continuous use of ventilatory support in the home and are at high risk for respiratory infections and mortality. Most of these patients need advanced nursing care and special respiratory equipment to prevent hospitalization such as manual chest physiotherapy, mechanical ex-sufflator device, chest vest device and increased ventilator support.
Recently the FDA approved of Pfizer's COVID 19 vaccine in ages 12 and older. It is anticipated that by fall 2021 the Pfizer COVID 19 vaccine will be approved by the FDA for children ages 2 and older. Vaccinating children will help decrease transmission of COVID 19, contribute to community immunity and allow kids go back to camps this summer and back to in-person school more safely.
Since the chronic home mechanical ventilation population is at risk for developing severe COVID 19 disease, the investigator would hypothesize that most parents are ready and willing to vaccinate their children. The purpose of this study is to evaluate the parental perception of COVID 19 vaccine in pediatric patients with "technology dependence" and identify the barriers to vaccination.
After surveys are collected and barriers are identified, vaccine counseling will be provided by a provider (nurse practitioner or physician). Vaccine safety, efficacy, side effects will be reviewed with the parents.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Parents of technology dependent pediatric patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Other caretakers such as grandparents, aunts, uncles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID 19 vaccine counselingAfter 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. | Behavioural | Pediatric Technology Dependent Patients at Ann & Robert H. Lurie Children's Hospital of Chicago, Pediatric Technology Dependent Patients at Cohen Children's Medical Center |
Primary outcome
Percentage of pediatric patient getting COVID 19 vaccine
Time frame: 6 months after initial survey
4 secondary outcomes
Percentage of mothers getting COVID 19 vaccine
Time frame: 6 months after initial survey
Percentage of fathers getting COVID 19 vaccine
Time frame: 6 months after initial survey
Percentage of other adults in household getting COVID 19 vaccine
Time frame: 6 months after initial survey
Percentage of other eligible children in household getting COVID 19 vaccine
Time frame: 6 months after initial survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 33935504Dosanjh 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.
- Background: PubMed 33389421Khubchandani 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.
- Background: PubMed 32282038McAteer 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.
- Background: PubMed 32615580Vasconcello-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Capusan, MSN principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure and Tracheostomy Complication, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pediatric patient getting COVID 19 vaccine (time frame: 6 months after initial survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084976, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.