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NCT04613739 · ClinicalTrials.gov registry record · NA

Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19

A NA study, sponsored by Harvard Pilgrim Health Care.

Completed
Registry status
NA
Development phase
56
Enrollment target

NCT04613739: Completed NA study, sponsored by Harvard Pilgrim Health Care.

NCT04613739 is a NA study that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04613739, a NA study, has completed, sponsored by Harvard Pilgrim Health Care.

COMPLETED
Registry status
NA
Development phase
56 participants
Enrollment target

Study Summary

In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes. Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care. In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four m

Primary Outcome

Coverage status (has any insurance coverage or not)

Interventions

  • BEHAVIORAL insurance navigation

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2020-12-08
Est. Completion 2021-09-01
Phase NA
Harvard Pilgrim Health Care

28 total trials

What the finished NCT04613739 record still lists

NCT04613739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which insurance navigation is the first listed.

NCT04613739 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04613739 about?

NCT04613739 is a clinical study titled "Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19". In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, hi...

What is the current status of trial NCT04613739?

This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2020-12-08. Estimated completion is 2021-09-01.

What interventions are being tested in trial NCT04613739?

The interventions under investigation include: insurance navigation (BEHAVIORAL).

Who is sponsoring clinical trial NCT04613739?

This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04613739's enrollment target sits among peer trials

56 1262nd of 2000 higher than 737 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04613739, the US trial registry maintained by the National Library of Medicine. NCT04613739 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.