Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy

NCT07233408 | Recruiting

• 2 other identifiers: 2024P002819HT9425-23-1-0457
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This decentralized, randomized study seeks to assess the feasibility, acceptability, and preliminary effectiveness of two approaches to assisting Neurofibromatosis 1 (NF1) patients with low health literacy improve their understanding of NF1 symptoms and care recommendations. Participants will be provided with personalized NF1 care letters for themselves and their doctors, along with either NF1 educational videos or a call with an NF1 peer navigator. 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

Conditions

Neurofibromatosis 1

Keywords

Neurofibromatosis; NF1; Guideline; Primary Care; Annual Care; Low Health Literacy; Healthcare; PCP

Outcome Measures

Primary Outcomes (1)

• Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide

  * Recruitment (% of people that complete prescreening who are eligible) * Willingness to Enroll (% of prescreening-eligible people who enroll) * Retention (% of consented individuals who complete both the baseline survey and follow-up survey) * Intervention Completion (% of people who watch all videos or complete peer navigator meeting, as applicable based on intervention assigned)

  2 weeks after PCP visit

Secondary Outcomes (2)

• Client Satisfaction Questionnaire (CSQ-8)

  2 weeks after PCP visit

• Telehealth Usability Questionnaire (TUQ)

  2 weeks after PCP visit

Study Arms (2)

NF1 Educational Videos

EXPERIMENTAL

Other: NF1 Educational Videos; Other: Letters about NF1 Care

Peer Navigator

EXPERIMENTAL

Other: Peer Navigator; Other: Letters about NF1 Care

Interventions

Letters about NF1 Care OTHER

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.

NF1 Educational Videos; Peer Navigator

NF1 Educational Videos OTHER

Participants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit.

NF1 Educational Videos

Peer Navigator OTHER

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.

Peer Navigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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

You may not qualify if:

• Unwilling or unable to give informed consent
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• United States Department of Defense: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35144646 BACKGROUND

• 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.

  PMID: 29119424 BACKGROUND

MeSH Terms

Conditions

Neurofibromatosis 1; Neurofibromatoses

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vanessa Merker, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Arias Hernandez, MSW

CONTACT

617-724-5321; pahernandez@mgb.org

Annika Coleman, BS

CONTACT

857-282-2167; acoleman0@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)