NCT02782065

Brief Summary

The purpose of this research will be to evaluate the reliability and validity of the HASS tool in a cohort of patients' ages 7 to18 years old against the gold standard of spirometry, and in ages 2 to 6 against spirometry, if possible, and the most similar validated tool, the PRAM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration 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

First Submitted

Initial submission to the registry

May 6, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 16, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

3.3 years

First QC Date

May 6, 2016

Results QC Date

December 16, 2020

Last Update Submit

March 1, 2021

Conditions

Asthma

Keywords

validationpediatricsasthma severity

Outcome Measures

Primary Outcomes (5)

  • Inter-rater Reliability for the Hospital Asthma Severity Score (HASS)

    The inter-rater reliability (the percent of agreement among raters) for the HASS as scored by 2 individual health care providers. Inter-rater agreement refers to the agreement between the single clinician who was Rater 1 and the second clinician rating the patient (Rater 2), regardless of which clinician served as Rater 2

    4 years and 9 months

  • Inter-rater Reliability for the Pediatric Respiratory Assessment Measure (PRAM)

    The inter-rater reliability for the PRAM as scored by 2 individual health care providers. Inter-rater agreement refers to the agreement between the single clinician who was Rater 1 and the second clinician rating the patient (Rater 2), regardless of which clinician served as Rater 2.

    4 years and 9 months

  • Intra-rater Reliability Between HASS and PRAM

    The intra-rater reliability between HASS and PRAM as scored by 2 individual health care providers. Intra-rater agreement refers to the with-in rater agreement between the PRAM and HASS categorical ratings. This was calculated separately for Rater 1 and Rater 2. The intra-rater agreement for Rater 2 was calculated by pooling the data from the Rater 2 clinicians.

    4 years and 9 months

  • Correlation Between the HASS and Forced Expiratory Volume in 1 Second (FEV1)

    The correlation coefficient between the HASS tool and FEV1 measurements.

    4 years, 9 months

  • Correlation Between the PRAM and FEV1

    The correlation between the PRAM and FEV1

    4 years 9 months

Study Arms (1)

Pediatric patients with Asthma

165 patients aged 7 to 18 years, and 30 patients aged 2 to 6 years

Other: Not an interventional study

Interventions

Not an interventional studyOTHER
Pediatric patients with Asthma

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with asthma exacerbation in the emergency room, inpatient medical units, and medicine intensive care unit

You may qualify if:

  • asthma exacerbation

You may not qualify if:

  • continuous albuterol and/or
  • pneumonia, croup, varicella, cystic fibrosis, broncho-pulmonary dysplasia, cardiac or kidney disease AND
  • previously approached for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Abecassis L, Gaffin JM, Forbes PW, Schenkel SR, McBride S, DeGrazia M. Validation of the Hospital Asthma Severity Score (HASS) in children ages 2-18 years old. J Asthma. 2022 Feb;59(2):315-324. doi: 10.1080/02770903.2020.1852414. Epub 2020 Dec 2.

    PMID: 33198536DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Leah Abecassis
Organization
Boston Children's Hospital
leah.abecassis@childrens.harvard.edu
6173552299

Study Officials

  • Leah Abecassis, MSN

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Practice Specialist

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 25, 2016

Study Start

September 29, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 23, 2021

Results First Posted

February 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

To ensure anonymity and confidentiality of participants, the investigators will not be sharing individual data. A summary report will be provided to participants upon request.

Locations

US(1)