Health Care UtilizationNCT05031741
Reducing Adolescent Sexual and Mental Health Disparities by Increasing Access to Telemedicine and Mobile Care
A study testing Peer Leader Model in people with Health Care Utilization, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Peer Leader Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 28 Dec 2021
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Care Utilization
- Being tested
- Peer Leader Model
- Keywords
- teen program, sexual health, mental health, AccessKCTeen
- Medical subject headings
- Patient Acceptance of Health Care, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Leader ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | 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. Receives: Other: Peer Leader Model |
| In-person Mobile Unit | Experimental | 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. Receives: Other: Peer Leader Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of any Sexual and Reproductive/Mental Health Care in past 30 days
Look at the uptake frequency in Sexual and Mental health care among participants within 30 days of baseline and educational interventions.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start5 Aug 2021
- Primary completion22 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will assign participants a Telemedicine or In-person Mobile unit card as they enroll in the study at events. Teens with a telemedicine card will get education exposure to telemedicine with a video and an ipad that demonstrates a pretend telehealth visit. Teens with an In-person mobile unit card will have the opportunity to learn how a health visit can be done on the unit with a health care provider.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Responsible party
- Principal investigator, Melissa Miller, Children's Mercy Hospital Kansas City
- Investigators
- Melissa Miller, MD, Principal investigator, Children's MercyEmily Hurley, PhD, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031741
- Sponsor's protocol ID
- STUDY00001900
- Status last verified
- Jan 2022
- First submitted
- 20 Aug 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention to Reduce Adolescent Sexual and Mental Health Disparities by Increasing Access to Telemedicine and Mobile Care (AccessKCTeen)
- ClinicalTrials.gov ID
- NCT05031741
- Acronym / sponsor ID
- STUDY00001900
- Conditions
- Health Care Utilization
- Keywords
- teen program, sexual health, mental health, AccessKCTeen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 2 Sep 2021 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will assign participants a Telemedicine or In-person Mobile unit card as they enroll in the study at events. Teens with a telemedicine card will get education exposure to telemedicine with a video and an ipad that demonstrates a pretend telehealth visit. Teens with an In-person mobile unit card will have the opportunity to learn how a health visit can be done on the unit with a health care provider.
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: Peer Leader ModelTeens 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. |
| In-person Mobile Unit | Experimental | Other: Peer Leader ModelTeens 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Peer Leader ModelTeens 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. | Other | In-person Mobile Unit, Telemedicine |
Primary outcome
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.
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 15 Feb 2022.
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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.
Melissa Miller, MD principal investigator
Children's Mercy
Emily Hurley, PhD principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Leader Model in people with Health Care Utilization, run by Children's Mercy Hospital Kansas City at 1 site 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 2 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Uptake of any Sexual and Reproductive/Mental Health Care in past 30 days (time frame: one month). 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 15 Feb 2022.