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

Not Applicable

Recruiting

• Conditions: Neurofibromatosis 1

• Registration Number: NCT07233408
• Lead Sponsor: Massachusetts General Hospital

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

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 Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study Start: 2025-11-17
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18
• Primary Completion: 2026-04-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide	2 weeks after PCP visit	* 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)

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ-8)	2 weeks after PCP visit	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.
Telehealth Usability Questionnaire (TUQ)	2 weeks after PCP visit	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States