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Completed

NCT Number: NCT06843564

Remote Enhanced Assessment for Care at Home (REACH)

The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.

The main question it aims to answer are:

- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.

Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.

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Key information

Conditions

Common Childhood Illnesses

Age range

6 month–20 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Community Pediatrics - Castle Shannon, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

The investigators will prospectively enroll 100 children (6 month 0 days to 8 months 30 days) in this one-arm pilot feasibility study. Enrolled participants will receive kits including pulse oximeters, thermometers, and tele-otoscopes as well as respiratory viral swab tests and will complete a test call with study team members to confirm ability to connect and use the devices.

After enrollment, families will continue to seek care based on their own preferences and primary care clinic guidance, but will have the ability to provide additional information to their primary care clinicians when primary care telemedicine visits occur.

The investigators will ask families to complete online surveys at 0, 30, and 180 days, and the investigators will perform chart reviews to capture visits (telemedicine and in-person to primary care, urgent care, and emergency department) and antibiotic receipt.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants receiving care at study sites presenting for primary care child visit
  • Infants between 6m0d and 20m30d

Exclusion criteria

  • Caregiver not able to consent in English or Spanish
  • Child has chronic condition (prematurity <33 weeks, congenital anomaly)
  • Child is ward of the state
  • Family lacks device and/or wifi plan to be able to participate in telemedicine visits

Treatment and study plan

Remote Enhanced Assessment for Care at Home (REACH) Kit

Other

Families of 6 month old infants will receive tele-device kits that include thermometers, pulse oximeters, and tele-otoscopes and respiratory swab tests, which families will then have the option to use when they schedule telemedicine visits with their usual primary care practice.

Note that the investigators are not studying the devices themselves; the investigators are instead studying health care use and experiences when these devices are made available.

Primary outcomes

  1. Retention

    Time frame: From enrollment to survey completed 6 months after enrollment, up to 18 months

    Percent who complete 6 months survey

Secondary outcomes

  1. Recruitment

    Time frame: Day approached for recruitment, up to one year

    Percent of individuals approached who consent

  2. Caregiver Satisfaction

    Time frame: From enrollment to survey completed 6 months after enrollment, up to 18 months

    Caregiver satisfaction with care using the tele-device kit as reported at 6 month survey. Satisfaction will be assessed a single Likert scale survey item, ranging from 0 to 4, with higher scores indicating greater satisfaction with care.

  3. Kit utilization

    Time frame: From enrollment to survey completed 6 months after enrollment

    Number of primary care telemedicine visits where kit devices are and are not used, assessed through both survey and through chart review.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility Trial

Acronym: REACH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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