Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02702687
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2016-02-25
Brief Title:
Childhood Asthma Perception Study
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Childhood Asthma Perception Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
Brief Summary:
This randomized controlled trial will include Latino and Black adolescents with asthma ages 10-17 years old and their caregivers Participants will be recruited from clinics in the Bronx New York The primary aims are to examine the efficacy of peak expiratory flow PEF prediction with feedback versus control feedback on 1 under-perception of asthma symptoms 2 controller medication adherence and 3 asthma control and emergency health care use These aims will be examined across a 1-year follow-up An exploratory aim examines the hypothesized pathway that the PEF intervention reduces under-perception of symptoms shifts illness representations toward the professional model and increases adolescents and parents asthma management self-efficacy resulting in greater medication adherence and improved asthma control
Detailed Description:
Under-perception of asthma symptoms in children is a major risk factor for emergency department visits hospitalizations and near-fatalfatal asthma attacks Puerto Rican and Black children have greater asthma morbidity and mortality rates than all other racialethnic groups Interventions targeting asthma symptom perception and medication adherence may help close this asthma health disparities gap
The baseline visit for all families consists of standardized asthma education followed by 3 weeks of PEF prediction without feedback using a programmable electronic spirometer Participants then will be randomized to intervention group or control feedback group and receive a brief feedback session For the next 6 weeks all adolescents will predict their PEF which will be locked in before blowing into the device Families will return at mid-intervention and post-intervention to receive feedback sessions All adolescents will play an interactive asthma educational game to reinforce the baseline asthma education At the post-intervention visit the spirometer will be reprogrammed for the next 4 weeks These symptom perception data will be downloaded at 1-month post-intervention Controller medication adherence will be monitored by electronic devices Post-intervention sessions will take place at 3 6 9 and 12 months to collect adherence data and conduct spirometry Physicians will be blinded to group assignment and rate asthma severity using national guidelines A 12-month retrospective medical record abstraction will compare emergency health care use for asthma between groups
The baseline visit for all families consists of standardized asthma education followed by 3 weeks of PEF prediction without feedback using a programmable electronic spirometer Participants then will be randomized to intervention group or control feedback group and receive a brief feedback session For the next 6 weeks all adolescents will predict their PEF which will be locked in before blowing into the device Families will return at mid-intervention and post-intervention to receive feedback sessions All adolescents will play an interactive asthma educational game to reinforce the baseline asthma education At the post-intervention visit the spirometer will be reprogrammed for the next 4 weeks These symptom perception data will be downloaded at 1-month post-intervention Controller medication adherence will be monitored by electronic devices Post-intervention sessions will take place at 3 6 9 and 12 months to collect adherence data and conduct spirometry Physicians will be blinded to group assignment and rate asthma severity using national guidelines A 12-month retrospective medical record abstraction will compare emergency health care use for asthma between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL128260-01 | NIH | None | httpsreporternihgovquickSearch1R01HL128260-01 |