Common Childhood IllnessesREACHNCT06843564
Remote Enhanced Assessment for Care at Home (REACH)
A study testing Remote Enhanced Assessment for Care at Home (REACH) Kit in people with Common Childhood Illnesses, run by University of Pittsburgh at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 20 months
- Conditions the study is for
- Common Childhood Illnesses
- What is being tested?
- Remote Enhanced Assessment for Care at Home (REACH) Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants receiving care at study sites presenting for primary care child visit
- Infants between 6m0d and 20m30d
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Children's Hospital of Pittsburgh Primary Care Center
Pittsburgh, Pennsylvania, 15213
UPMC Children's Community Pediatrics - Castle Shannon
Pittsburgh, Pennsylvania, 15234
About this study
Official title: Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Common Childhood Illnesses
- Being tested
- Remote Enhanced Assessment for Care at Home (REACH) Kit
- Keywords
- Telemedicine, Telehealth, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Enhanced Assessment for Care at Home (REACH) KitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Device Kit Arm | Experimental | 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. Receives: Other: Remote Enhanced Assessment for Care at Home (REACH) Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Percent who complete 6 months survey
Measured: From enrollment to survey completed 6 months after enrollment, up to 18 months
Secondary outcomes (3)
Recruitment
Percent of individuals approached who consent
Measured: Day approached for recruitment, up to one year
Caregiver Satisfaction
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.
Measured: From enrollment to survey completed 6 months after enrollment, up to 18 months
Kit utilization
Number of primary care telemedicine visits where kit devices are and are not used, assessed through both survey and through chart review.
Measured: From enrollment to survey completed 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start7 May 2025
- Primary completion28 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Childhood IllnessesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Ray, University of Pittsburgh
- Investigators
- Kristin Ray, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843564
- Sponsor's protocol ID
- STUDY24110038
- Acronym
- REACH
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06843564
- Acronym / sponsor ID
- REACH / STUDY24110038
- Conditions
- Common Childhood Illnesses
- Keywords
- Telemedicine, Telehealth, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-Device Kit Arm | Experimental | Other: Remote Enhanced Assessment for Care at Home (REACH) KitFamilies 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 may qualify
- Ages
- 6 to 20 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants receiving care at study sites presenting for primary care child visit
- Infants between 6m0d and 20m30d
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Enhanced Assessment for Care at Home (REACH) KitFamilies 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. | Other | Tele-Device Kit Arm |
Primary outcome
Retention
Time frame: From enrollment to survey completed 6 months after enrollment, up to 18 months
Percent who complete 6 months survey
3 secondary outcomes
Recruitment
Time frame: Day approached for recruitment, up to one year
Caregiver Satisfaction
Time frame: From enrollment to survey completed 6 months after enrollment, up to 18 months
Kit utilization
Time frame: From enrollment to survey completed 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Ray, MD, MS principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Enhanced Assessment for Care at Home (REACH) Kit in people with Common Childhood Illnesses, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: From enrollment to survey completed 6 months after enrollment, up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.