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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)

Must not have

Excluded are those with other chronic lung diseases: lung cancer, cystic fibrosis, heart failure, chronic bronchitis, pulmonary hypertension, a candidate or recipient for lung transplant, a history of bronchial thermoplasty.

Excluded are those with more than 20 pack year tobacco use.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 18

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have chronic lung diseases like cystic fibrosis or pulmonary hypertension.

Select...

I have smoked 20 or fewer pack-years of cigarettes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 18

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma Control at 12 months

Asthma Control at 15 months

Asthma Control at 18 months

+4 more

Secondary study objectives

Emergency Department (ED) visits for asthma

Forced expiratory volume in 1 second (FEV1)

asthma-related quality of life

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met