Remote Assessment Kits for Common Childhood Diseases

(REACH Trial)

Not currently recruiting at 1 trial location

Overseen By Kristin Ray, MD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Chronic condition, Ward of state, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the ease and usefulness of special telemedicine kits, known as Remote Enhanced Assessment for Care at Home (REACH) Kits, during online doctor visits. These kits include tools like thermometers and pulse oximeters to help doctors remotely assess infants' health. The trial targets families with infants aged 6 to 21 months who already receive care at specific sites. Participants will share their experiences through surveys and provide access to their electronic health records. Families must have the necessary devices and internet access to participate. As an unphased trial, this study offers families the chance to contribute to innovative healthcare solutions that could improve remote care for infants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that these tele-peripheral devices are safe for infants?

Research shows that remote assessment kits, such as the Remote Enhanced Assessment for Care at Home (REACH) Kit, are safe for home use. These kits include devices like thermometers and pulse oximeters, which people have used at home without major safety concerns. No evidence of serious side effects from these devices has been found.

This trial focuses on using technology for healthcare visits rather than testing new drugs, so the safety risks are considered low. The trial's phase is "Not Applicable," indicating it examines how families use these kits rather than testing a new drug or invasive treatment. This suggests no known safety issues with the kit itself.

Overall, using these devices at home with guidance appears safe, with no negative effects reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Remote Enhanced Assessment for Care at Home (REACH) Kit is unique because it empowers families to perform at-home health assessments using tele-devices like thermometers, pulse oximeters, tele-otoscopes, and respiratory swab tests. Unlike traditional doctor visits where these tests are conducted in a clinical setting, this kit allows for convenient home monitoring, which can be particularly beneficial for families with young infants. Researchers are excited about this trial because it could revolutionize how common childhood illnesses are managed by making healthcare more accessible, reducing the need for in-person visits, and potentially leading to quicker interventions through telemedicine.

What evidence suggests that the REACH Kit is effective for remote assessments in telemedicine visits?

Research has shown that remote exam tools, like those in the REACH Kit, can provide results similar to in-person exams. In this trial, families of 6-month-old infants will receive the REACH Kit, which includes tele-device tools such as thermometers, pulse oximeters, and tele-otoscopes. Studies have found these tools effective for physical exams during telemedicine visits, and evidence indicates they are easy to use at home. Additionally, telemedicine is associated with high patient satisfaction and improved health outcomes. Therefore, using the REACH Kit could enhance the quality of telemedicine visits for infants. ^{6 7 8 9 10}

Who Is on the Research Team?

Kristin Ray, MD, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

The REACH trial is for infants aged between 6 months and just under 9 months who are due for a well-child visit. They must be cared for at participating sites, have caregivers who can consent in English or Spanish, and have access to a device and Wi-Fi for telemedicine visits. Infants with certain chronic conditions or state custody are not eligible.

Inclusion Criteria

My child is between 6 and almost 9 months old.

My infant is having a 6-month check-up at a study site.

Exclusion Criteria

My caregiver cannot consent in English or Spanish.

Child has chronic condition (prematurity <33 weeks, congenital anomaly)

Child is ward of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Kit Distribution

Participants are enrolled and receive tele-device kits including pulse oximeters, thermometers, and tele-otoscopes. A test call is conducted to confirm device connectivity and usage.

1 week

1 visit (virtual)

Telemedicine Visits

Participants use tele-device kits during telemedicine visits with their primary care practice. Families complete online surveys at 0, 30, and 180 days.

6 months

Multiple visits (virtual and in-person as needed)

Follow-up

Participants are monitored for retention and caregiver satisfaction through surveys and chart reviews.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Remote Enhanced Assessment for Care at Home (REACH) Kit

Trial Overview This trial tests the use of a 'REACH Kit' containing tele-peripheral devices during live-interactive primary care telemedicine visits. It aims to assess how practical and acceptable it is for families to use these kits from home when consulting their usual primary care providers.

How Is the Trial Designed?

Group I: Tele-Device Kit Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Digital health interventions, such as mobile apps and electronic health records, can enhance patient safety for children and their parents by providing preventive measures and risk management strategies, as identified in a scoping review of 13 studies.

These interventions can improve the continuity of care from hospitalization to home, thereby increasing children's safety and quality of care through better engagement with healthcare providers after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. Park, J., Jeon, H., Choi, EK.[2023]

In a 1-year study involving 310 parents of children with chronic diseases, the incidence of medication errors (MEs) was found to be 0.46 errors per child, with the highest risk observed in children under 1 year old (1.69 errors per child).

Children discharged from the cardiology unit had a significantly higher risk of medication errors (IRR of 3.66), highlighting the need for targeted monitoring and support for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study. Tiozzo, E., Rosati, P., Brancaccio, M., et al.[2023]

Parents of young children with type 1 diabetes reported that remote monitoring technology significantly improved their ability to manage their child's glucose levels, allowing them to engage in non-diabetes-related activities while still overseeing their child's care.

The use of a hybrid closed-loop insulin delivery system increased parents' confidence in allowing others to care for their children, enabling kids to enjoy activities like sleepovers and parties without constant parental supervision, although some parents expressed a need for breaks from caregiving responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Hart, RI., Kimbell, B., Rankin, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9896296/

Assessment of Pediatric Telemedicine Using Remote ... Measurements from remote physical examination (via teleinterconsultation) with a mobile medical device were comparable with those from in-person physical ...

2. liebertpub.com liebertpub.com/doi/full/10.1089/tmj.2024.0058

Usability and Feasibility of an in-Home Remote Exam ... Data from this pilot study supports the usability and feasibility of deploying a remote exam device across a telemedicine platform in a busy and ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1089/tmj.2024.0058?int.sj-abstract.similar-articles.1

Usability and Feasibility of an in-Home Remote Exam Device ... Remote exam devices that enable the performance of a physical exam could expand the ability of providers to clinically assess CMC during a telemedicine visit.

4. publications.aap.org publications.aap.org/pediatrics/article/150/1/e2021054520/188195/Clinical-Effectiveness-of-Telemedicine-Based

Clinical Effectiveness of Telemedicine-Based Pediatric ... Previous studies have identified high levels of patient satisfaction with telemedicine but disparities in its use. Telemedicine-mediated ...

5. advancedcarepartners.com advancedcarepartners.com/leveraging-technology-to-enhance-pediatric-home-health-outcomes/

Leveraging Technology to Enhance Pediatric Home Health Learn how technology enhances pediatric home health care, improving outcomes through telemedicine, remote monitoring, and mobile health tools.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06843564

Remote Enhanced Assessment for Care at Home (REACH) Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. withpower.com withpower.com/trial/phase-common-childhood-illnesses-2-2025-d2cc1

Remote Assessment Kits for Common Childhood Diseases ... The REACH Kit is unique because it allows for remote assessment and management of children's health conditions at home, using technology to coordinate care with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825998/

Implementation of remote home care: assessment guided ... This study aimed to report on the use of the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to assess the implementation of remote ...

9. researchgate.net researchgate.net/publication/315533304_Development_and_validation_of_a_remote_home_safety_protocol

Development and validation of a remote home safety protocol The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent ...

10. psnet.ahrq.gov psnet.ahrq.gov/perspective/remote-patient-monitoring

Remote Patient Monitoring | PSNet RPM is a type of telehealth in which healthcare providers monitor patients outside the traditional care setting using digital medical devices.