Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy
NCT ID: NCT07233408
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-31
2026-05-30
Brief Summary
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Adults with NF1 from across the U.S. who have upcoming annual wellness visits 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/nfpeer
Detailed Description
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Methods: Enrolled participants will complete baseline survey assessments online before their PCP visit and then be randomized to either the educational videos or peer navigator intervention group. Both groups will be given personalized letters, one for themselves and one for their clinician, that describe NF1 care recommendations. After attending their annual wellness visit, all participants will be asked to complete an online follow-up survey. A small subsample of participants will also be asked to do a virtual qualitative interview. No visits to Massachusetts General Hospital are required for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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NF1 Educational Videos
NF1 Educational Videos
Participants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit.
Letters about NF1 Care
Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit.
Peer Navigator
Peer Navigator
Participants will receive a phone or video call from an NF1 peer navigator. The navigator will explain NF1 health surveillance recommendations and coach individuals on how to discuss these recommendations with their provider.
Letters about NF1 Care
Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit.
Interventions
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NF1 Educational Videos
Participants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit.
Peer Navigator
Participants will receive a phone or video call from an NF1 peer navigator. The navigator will explain NF1 health surveillance recommendations and coach individuals on how to discuss these recommendations with their provider.
Letters about NF1 Care
Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit.
Eligibility Criteria
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Inclusion Criteria
* Currently lives in the United States
* Has a clinical diagnosis of Neurofibromatosis 1
* Speaks English
* Has low health literacy as ascertained by standardized instruments
* Has an in-person, well-person visit (e.g. not a visit to address an acute medical issue) with their primary care provider (PCP) scheduled within the 3 months following their consent
Exclusion Criteria
* Is too cognitively impaired to participate in the opinion of the study investigator (e.g. any cognitive or developmental delay that prevents completion of study questionnaires)
* Was enrolled in or is the parent or guardian of a participant enrolled in randomized clinical trial NCT06262113
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Massachusetts General Hospital
OTHER
Responsible Party
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Vanessa Merker, PhD
Assistant Professor of Neurology
Principal Investigators
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Vanessa Merker, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Paulina Arias Hernandez, MSW
Role: primary
Annika Coleman, BS
Role: backup
References
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Merker VL, Knight P, Radtke HB, Yohay K, Ullrich NJ, Plotkin SR, Jordan JT. Awareness and agreement with neurofibromatosis care guidelines among U.S. neurofibromatosis specialists. Orphanet J Rare Dis. 2022 Feb 10;17(1):44. doi: 10.1186/s13023-022-02196-x.
Merker VL, McDannold S, Riklin E, Talaei-Khoei M, Sheridan MR, Jordan JT, Plotkin SR, Vranceanu AM. Health literacy assessment in adults with neurofibromatosis: electronic and short-form measurement using FCCHL and Health LiTT. J Neurooncol. 2018 Jan;136(2):335-342. doi: 10.1007/s11060-017-2657-8. Epub 2017 Nov 8.
Other Identifiers
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HT9425-23-1-0457
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024P002819
Identifier Type: -
Identifier Source: org_study_id