Remote Assessment Kits for Common Childhood Diseases

(REACH Trial)

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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the REACH Kit treatment?

The REACH Project has shown success in providing specialized health care and case management for children with chronic illnesses, suggesting that remote assessment and coordination can be effective in managing complex health needs at home. Additionally, remote technology has been found feasible and reliable for cognitive assessments in children with rare diseases, indicating potential for broader applications in remote health care. ^{1 2 3 4 5}

Is the Remote Assessment Kit for Common Childhood Diseases safe for use in children?

The REACH Project, which provides health care services to medically dependent children, has shown positive effects on children's health, though specific safety data for the Remote Assessment Kit itself is not detailed. The program's focus on monitoring and coordination suggests a structured approach to safety, but more specific safety data for the kit would be needed. ^{1 6 7 8 9}

How is the REACH Kit treatment different from other treatments 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 healthcare professionals. This approach is particularly beneficial for families in rural areas or those with limited access to specialized medical care, making it different from traditional in-person treatments. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Research Team

Kristin Ray, MD, MS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The REACH Project: an innovative health delivery model for medically dependent children. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Remote Assessment of Cognitive Function in Juvenile Neuronal Ceroid Lipofuscinosis (Batten disease): A Pilot Study of Feasibility and Reliability. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Collaborating With Parents of Children With Chronic Conditions and Professionals to Design, Develop and Pre-pilot PLAnT (the Parent Learning Needs and Preferences Assessment Tool). [2018]

4. United States pubmed.ncbi.nlm.nih.gov

interRAI Pediatric Home Care (PEDS-HC) Assessment Tool: Evaluating Ontario Healthcare Workers' Experience. [2022]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Retrospective Chart Review: Readmission Prediction Ability of the High Acuity Readmission Risk Pediatric Screen (HARRPS) Tool. [2021]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an interagency home visiting program to reduce postneonatal mortality in disadvantaged communities. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Pedi-R-MAPP: The development of a nutritional awareness tool for use in remote paediatric consultations using a modified Delphi consensus. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Telemonitoring of motor skills using the Alberta Infant Motor Scale for at-risk infants in the first year of life. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Pedi-R-MAPP | the development, testing, validation, and refinement of a digital nutrition awareness tool. [2023]