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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: 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.
  • 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.

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Paulina Arias Hernandez, MSW
617-724-5321
pahernandez@mgb.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Paulina Arias Hernandez, MSW
617-724-5321
pahernandez@mgb.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.