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

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

Study Overview

• Status: Recruiting
• Conditions: Neurofibromatosis 1
• Intervention / Treatment: Other: NF1 Educational Videos; Other: Letters about NF1 Care; Other: Peer Navigator

Detailed Description

Background: Previous studies indicate that patient understanding of NF1 symptoms and screening for health issues such as hypertension, scoliosis, and cancers could be improved. Many individuals with NF1 have learning challenges, complicating their ability to access NF1 information. To address this gap, researchers are evaluating two interventions to promote understanding of NF1 care within adults with low health literacy.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulina Arias Hernandez, MSW; Phone Number: 617-724-5321; Email: pahernandez@mgb.org
• Study Contact Backup: Name: Annika Coleman, BS; Phone Number: 857-282-2167; Email: acoleman0@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Paulina Arias Hernandez, MSW; Phone Number: 617-724-5321; Email: pahernandez@mgb.org
      • Contact: Annika Coleman, BS; Phone Number: 857-282-2167; Email: acoleman0@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NF1 Educational Videos	Other: 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.; Other: 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.
Experimental: Peer Navigator	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 will be used to assess client satisfaction with the My NF Guide/PEER Resource package (i.e. personalized letters and either NF1 educational videos or peer navigator). It consists of 8 items rated on a 4-point Likert scale, yielding scores that range from 8 to 32. Higher scores indicate greater satisfaction with the services provided.	2 weeks after PCP visit
Telehealth Usability Questionnaire (TUQ)	The TUQ will be used to evaluate the ease of use, usefulness, and reliability with the My NF Guide/PEER Resource package (i.e. personalized letters and either NF1 educational videos or peer navigator). It consists of 21 items rated on a seven-point Likert scale ranging from "strongly disagree" to "strongly agree," with a higher average score indicating better usability. The overall usability score will be calculated as the mean of all applicable responses, and sub-scores for specific domains such as usefulness, ease of use, and reliability will be computed for detailed analysis.	2 weeks after PCP visit

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Vanessa Merker, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Primary Care; Guideline; NF1; Neurofibromatosis; PCP; Healthcare; Low Health Literacy; Annual Care
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neoplasms by Histologic Type; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Heredodegenerative Disorders, Nervous System; Nerve Sheath Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Neurofibroma; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurofibromatoses; Neurofibromatosis 1
• Other Study ID Numbers: 2024P002819; HT9425-23-1-0457 (Other Grant/Funding Number: U.S. Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No