Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-21 @ 1:53 PM
Study NCT ID:
NCT07224061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Follow up assessments will be collected by blinded interviewers'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2025-10-30', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health care utilization - number of Emergency Department (ED) visits for asthma', 'timeFrame': 'every 4 months up to 12 months', 'description': 'The number of ED visits directly related to asthma will be summarized by study arm every four months up to 12 months in total.'}, {'measure': 'Health care utilization - number of hospitalizations for asthma', 'timeFrame': 'every 4 months up to 12 months', 'description': 'The number of hospitalizations directly related to asthma will be summarized by study arm every four months up to 12 months in total.'}], 'primaryOutcomes': [{'measure': 'Asthma Control - continuous', 'timeFrame': 'Baseline, 4 months, 8 months, and 12 months', 'description': 'Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.\n\nAsthma control will be analyzed as a continuous variable.'}], 'secondaryOutcomes': [{'measure': "Pediatric Asthma Caregiver's Quality of Life", 'timeFrame': 'Baseline, 4 months, 8 months, and 12 months', 'description': 'The caregiver\'s quality of life will be assessed using the validated Pediatric Asthma Caregiver\'s Quality of Life Questionnaire (PACQLQ; also referred to as Juniper\'s Asthma Quality of Life Questionnaire). This questionnaire consists of 13 items which evaluate the impact of the child\'s asthma on the caregiver\'s quality of life. Responses to each item are rated on a 7-point scale ranging from 1-7, wherein 1 means "all of the time" or "very, very worried/concerned," and 7 means "none of the time" or "not worried/concerned," yielding an overall possible scoring range of 7-91, such that higher scores are indicative of less asthma related quality of life impairment.'}, {'measure': 'Percent of participants with 1 or more guideline-based corrective actions taken', 'timeFrame': 'Up to 24 months (following intervention)', 'description': 'Percent of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR), will be summarized by study arm.'}, {'measure': 'Asthma Control - dichotomous', 'timeFrame': 'Baseline, 4 months, 8 months, and 12 months', 'description': 'Asthma control will also be measured as a dichotomous variable using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.\n\nAsthma control will be analyzed as dichotomous variable with a score of 19 or less indicating uncontrolled asthma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma in Children']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Walters S, Wilson L, Konty K, Day S, Agerton T, Olson C. Disparities among children with asthma in New York City. Epi Data Brief (126); September 2021.'}, {'type': 'BACKGROUND', 'citation': 'Black LI, Benson V. 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PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.', 'detailedDescription': 'The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.\n\nParticipants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-diagnosed asthma documented in EHR\n* Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)\n* Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools\n* Caregiver able to speak English or Spanish\n* Consent from primary caregiver and assent from child (if ≥7 years)\n* Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms\n\nExclusion Criteria:\n\n* Family plans to leave school/city within 6 months\n* Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)\n* Children in foster care or situations where legal guardian consent cannot be obtained\n* Participation in concurrent asthma intervention study\n* Severe developmental delay precluding completion of ACT questionnaire'}, 'identificationModule': {'nctId': 'NCT07224061', 'acronym': 'PRAGMATIC-S', 'briefTitle': 'Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)', 'orgStudyIdInfo': {'id': '2025-17054'}, 'secondaryIdInfos': [{'id': 'R01HL181061', 'link': 'https://reporter.nih.gov/quickSearch/R01HL181061', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRAGMATIC-S', 'description': 'Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support.', 'interventionNames': ['Behavioral: PRAGMATIC-S']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care', 'description': 'Standard of care EHR clinician prompts for guideline-based asthma care'}], 'interventions': [{'name': 'PRAGMATIC-S', 'type': 'BEHAVIORAL', 'description': 'Intervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers.', 'armGroupLabels': ['PRAGMATIC-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Marina Reznik, MD, MS', 'role': 'CONTACT', 'email': 'mreznik@montefiore.org', 'phone': '718-741-2494'}], 'facility': "Children's Hospital at Montefiore, Albert Einstein College of Medicine", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Marina Reznik, MD, MS', 'role': 'CONTACT', 'email': 'mreznik@montefiore.org', 'phone': '718-741-2494'}], 'overallOfficials': [{'name': 'Marina Reznik, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}