- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031741
Reducing Adolescent Sexual and Mental Health Disparities by Increasing Access to Telemedicine and Mobile Care
January 31, 2022 updated by: Melissa Miller, Children's Mercy Hospital Kansas City
A Pilot Intervention to Reduce Adolescent Sexual and Mental Health Disparities by Increasing Access to Telemedicine and Mobile Care (AccessKCTeen)
Investigators will attend a series of community outreach events that provide/demonstrate telemedicine and the Children's Mercy Mobile Unit which is equipped to provide direct patient care.
Investigators will engage up to 12 teen peer leaders to encourage healthcare-seeking behaviors and mobilize their social networks to attend outreach events.
At all events, the mobile unit will be available for teens to (a) demonstrate the mobile unit and telehealth experience; (b) learn about Sexual and Reproductive Health/Mental Health (SRH/MH) and local care resources; (c) register for future telemedicine care; (d) acquire free over-the-counter emergency contraception, condoms, and pregnancy tests.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
AccessKCTeen is a pilot clinical outreach program that uses Children Mercy's Mobile Unit and Telemedicine to demonstrate and increase access to SRH and MH. AccessKCTeen intends to focus on these central activities:
- Education based on a peer-leader model: In collaboration with community-based partners, investigators will identify and train approximately 12 peer leaders in disseminating information and resources for MH/SRH to their social networks. Peer leaders may disseminate information in the form of sharing curated online resources or mobilizing friends to attend live educational events. Peer leaders will also help connect their friends to resources by spreading information and encouraging friends to attend CM mobile unit demonstrations. Investigators will use text messaging to engage peers in these educational events and share general health resources.
- Mobile Unit and Telemedicine Demonstration Events: The mobile unit will be present at community events to demonstrate how in-person care could work on the unit as well as how telemedicine works. Investigators will answer questions and help adolescents get registered for telemedicine.
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Telemedicine or In-person Mobile unit arms: Aged 14-18 years old and Attended a Mobile Unit Demonstration
- Peer leaders: At least 14 years old
Exclusion Criteria:
- Telemedicine or In-person Mobile unit arms: Younger than 14 years old, 19 years of age or older, did not attend a Mobile Unit Demonstration, does not speak/understand English
- Peer leaders: Younger than 14 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telemedicine
Teens who are randomly assigned a telemedicine card will have exposure to a pretend telemedicine visit equipped with an iPad and telehealth provider on the other end.
The study team will demonstrate how a teen can acquire sexual and reproductive health as well as mental health care through telemedicine from their own home or private space.
|
Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program.
These leaders will receive a baseline training of their role, sexual and mental health.
They will also receive health education and engage with a peer liason via text messages throughout the study.
|
Experimental: In-person Mobile Unit
Teens who are randomly assigned a in-person mobile unit card will have exposure to a pretend mobile unit visit equipped with a healthcare provider.
The study team will demonstrate how a teen can acquire sexual and reproductive health as well as mental health care on the mobile unit.
|
Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program.
These leaders will receive a baseline training of their role, sexual and mental health.
They will also receive health education and engage with a peer liason via text messages throughout the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake of any Sexual and Reproductive/Mental Health Care in past 30 days
Time Frame: one month
|
Look at the uptake frequency in Sexual and Mental health care among participants within 30 days of baseline and educational interventions.
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Melissa Miller, MD, Children's Mercy
- Principal Investigator: Emily Hurley, PhD, Children's Mercy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2021
Primary Completion (Actual)
December 22, 2021
Study Completion (Actual)
December 28, 2021
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
September 2, 2021
Study Record Updates
Last Update Posted (Actual)
February 15, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001900
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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