Patient Advocacy + Home Visits for Asthma

(HAP3 Trial)

Recruiting at 1 trial location

Overseen By Juliet Kohli, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Inhaled corticosteroids

Disqualifiers: Severe psychiatric, Chronic lung diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

367 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to assist people with asthma, particularly those in low-income urban areas, by improving condition management. It combines patient advocacy during doctor visits and home visits to determine if this approach enhances asthma care effectiveness. Participants will join one of four groups to test different combinations of these clinical interventions. The trial aims to improve asthma control, reduce emergency visits, and enhance overall quality of life. Individuals with asthma who required emergency care or strong medication like prednisone in the past year might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative asthma care strategies that could significantly improve quality of life.

What prior data suggests that these interventions are safe for asthma patients?

Research has shown that clinical methods like patient support and home visits for asthma are generally safe. Studies have found that using community health workers to help patients manage asthma is well-tolerated. This includes preparing for doctor visits and improving home conditions that affect asthma.

One study found that patients who received home visits from community health workers experienced better asthma outcomes. These workers help by identifying issues at home that could worsen asthma. Another study showed that providing doctors with real-time updates about patients' health and home environments also improved asthma care.

Research has not reported any major adverse reactions. These methods focus on better communication and care coordination rather than new drugs or procedures, which can lower safety risks. Overall, the evidence suggests these asthma care methods are safe for people to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to managing asthma, beyond just medication. Unlike standard treatments that primarily focus on prescribing inhalers or medications to control symptoms, this trial investigates the impact of combining clinical interventions with home visits and personalized feedback. This approach aims to address underlying social and environmental factors that can trigger asthma, potentially leading to more effective and tailored care. The trial could provide valuable insights into how integrating patient advocacy and home environments into treatment plans can improve asthma management and patient outcomes.

What evidence suggests that this trial's treatments could be effective for asthma?

This trial will evaluate various combinations of clinical interventions, home visits, and feedback to help people manage asthma more effectively. Research has shown that combining clinic visits with home visits and feedback can be effective. One study found that patients who received home visits managed their asthma more effectively than those who did not. Another study discovered that when doctors received real-time updates about a patient's health and home environment, asthma control improved. Home visits can identify potential asthma triggers in the home, leading to better overall care. These approaches aim to enhance communication between patients and doctors and reduce asthma-related emergencies. Participants in this trial may receive a combination of these interventions to assess their effectiveness. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with asthma by a doctor.

A patient in a participating clinic

I have asthma and may also have COPD, especially if I smoke.

Exclusion Criteria

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

Severe psychiatric or cognitive problems making it impossible to understand or carry out the protocol

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Intervention

Participants receive a clinical intervention facilitated by a community health worker, including preparation for, attendance at, and confirmation of understanding of office visits.

12 months

Quarterly visits

Home Visits

Participants receive home visits for care coordination, taking into account the home environment and its social and physical characteristics.

12 months

Follow-up

Participants are monitored for sustainability of interventions and outcomes.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinical intervention
• Feedback

Trial Overview 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.

How Is the Trial Designed?

Group I: Clinical intervention AND Home Visit AND Feedback Experimental Treatment 2 Interventions

Group II: Clinical intervention AND Home Visit Experimental Treatment 2 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 Feedback Experimental Treatment 2 Interventions

Group IV: Clinical intervention Active Control 2 Interventions

Clinical health navigator, a community health worker, facilitates preparation for, attends, and confirms patients's understanding of an office visit.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7961946/

a call for core outcomes in interventional trials - PMC We identified 117 studies and subsequently identified 111 outcomes. The most prevalent outcomes were asthma control and symptom severity, FEV1, and change in ...

2. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)05442-4/fulltext

Implementation and Effectiveness of Guideline ... Standalone annual asthma reviews were associated with a 9% significant decrease in exacerbations only during the first 6 months (0-180 days: IRR ...

3. publications.ersnet.org publications.ersnet.org/content/erj/47/4/1134

Pharmacists' interventions on clinical asthma outcomes This systematic review finds that pharmacists have a positive impact on various clinical asthma outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611123003669

Systematic literature review of traits and outcomes reported ... A total of 11 clinical outcomes were reported in the trials (Table 2). Reliever use was the most reported outcome (89.3 %), and exacerbation rate, time to first ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.03.09.25323633v1.full-text

Unveiling the Best Asthma Control Regiment This study confirms that ICS/LABA combinations reduce exacerbations and improve PEFR, though with minimal effects on FEV1 and ACQ-5 scores.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895432/

How have we measured trial outcomes of asthma attack ... We carried out a systematic review to understand the characteristics of outcome measures used in randomised controlled trials of asthma attack treatment.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5450495/

Adherence Feedback to Improve Asthma Outcomes Among ... The aim of this randomized, controlled trial was to test the efficacy of asthma education combined with medication adherence feedback intervention.

8. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(21)01006-0/fulltext

Utilizing Culturally Tailored Approaches and Participant ... These results provide further supportive evidence that interventions that increase physical activity are beneficial in improving asthma outcomes. Data on longer ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825004088

Patient-Facing Digital Inhalers for Asthma: A Systematic ... Patient-facing digital inhalers probably improve asthma control and may reduce severe asthma exacerbations in patients at high risk for future exacerbations ...