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Patient Advocacy + Home Visits for Asthma (HAP3 Trial)

N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Doctor's diagnosis of asthma
Female or male > 18 years and living in a Philadelphia neighborhood in which at least 20% of households have incomes below the federal poverty level (19104, 19120, 19121, 19122, 19124, 19125, 19131, 19132, 19133, 19134, 19139, 19140, 19141, 19142, 19143, 19144, 19145, 19146, 19153, 19151)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights

HAP3 Trial Summary

This trial is exploring whether two interventions, a patient advocate and home visits, can improve asthma outcomes in low-income minority patients.

Who is the study for?
This trial is for adults over 18 with uncontrolled asthma living in low-income areas of Philadelphia. Participants must have a doctor's diagnosis of asthma, be prescribed an inhaled corticosteroid, and have had recent severe asthma issues like needing prednisone or hospital visits.Check my eligibility
What is being tested?
The study tests if patient advocates and home visits improve asthma care for low-income minority adults. It compares four approaches: just an advocate; an advocate plus home visits; an advocate with real-time clinician feedback; and all combined.See study design
What are the potential side effects?
Since the interventions involve non-medical support services (like patient advocacy and home visits), there are no direct medical side effects expected from participating in this clinical trial.

HAP3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with asthma by a doctor.
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I am over 18 and live in a low-income area of Philadelphia.
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I have asthma and may also have COPD, especially if I smoke.
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I needed prednisone or had to visit the ED or was hospitalized for asthma in the last year.
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I am using an inhaled corticosteroid for my asthma.

HAP3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma Control at 12 months
Asthma Control at 15 months
Asthma Control at 18 months
+4 more
Secondary outcome measures
Emergency Department (ED) visits for asthma
Forced expiratory volume in 1 second (FEV1)
asthma-related quality of life
+1 more

HAP3 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Clinical intervention AND Home Visit AND FeedbackExperimental Treatment2 Interventions
Group II: Clinical intervention AND Home VisitExperimental Treatment2 Interventions
Patient receives Clinical intervention and Home visits. Care coordination activities occur taking into account the home environment, its social and physical characteristics.
Group III: Clinical intervention AND FeedbackExperimental Treatment2 Interventions
Group IV: Clinical interventionActive Control2 Interventions
Clinical health navigator, a community health worker, facilitates preparation for, attends, and confirms patients's understanding of an office visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Feedback
2018
N/A
~18170

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,508 Total Patients Enrolled
276 Trials studying Asthma
112,279 Patients Enrolled for Asthma
University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,874,993 Total Patients Enrolled
10 Trials studying Asthma
1,844 Patients Enrolled for Asthma

Media Library

Clinical intervention Clinical Trial Eligibility Overview. Trial Name: NCT04023422 — N/A
Asthma Research Study Groups: Clinical intervention, Clinical intervention AND Home Visit AND Feedback, Clinical intervention AND Feedback, Clinical intervention AND Home Visit
Asthma Clinical Trial 2023: Clinical intervention Highlights & Side Effects. Trial Name: NCT04023422 — N/A
Clinical intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04023422 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment actively seeking participants?

"Reported on clinicaltrials.gov, this medical investigation has been actively recruiting since August 21st 2019 and was last modified on 26th of August 2022."

Answered by AI

How many participants are currently signed up for this research initiative?

"Affirmative. The clinicaltrials.gov website suggests that this trial is actively enlisting participants since it was first posted on August 21st 2019, with the most recent changes being made to the page on August 26th 2022. 400 patients need to be recruited from two medical centres."

Answered by AI

What are the expected outcomes of this research endeavor?

"The primary assessment of this clinical trial is Asthma Control measured over the course of 15 months. Secondary outcomes include: Emergency Department (ED) visits for asthma documented in electronic medical records and patient reports, an asthma-related quality of life score derived from a 15-item survey with higher scores indicating better health, as well as Forced Expiratory Volume in 1 second (FEV1)."

Answered by AI
~66 spots leftby Mar 2025