A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neuro… (NCT06262113) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
United States294 participantsStarted 2024-12-03
Plain-language summary
The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.
Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adult Inclusion Criteria:
* Currently lives in the United States (including Puerto Rico and other United States territories)
* Has a clinical diagnosis of neurofibromatosis 1
* Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
* Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
* Speaks English or Spanish
Parent/Guardian of a Child with NF1 Inclusion Criteria:
* Currently lives in the United States (including Puerto Rico and other United States territories)
* Cares for a child (age \<18 years) with a clinical diagnosis of neurofibromatosis 1
* Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
* Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
* Speaks English or Spanish
Exclusion Criteria:
* Only one person per household may participate in the study
* Unwilling or unable to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.