A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1

Phase

N/A

Condition

Warts

Brain Tumor

Treatment

Letters about NF1 Care (Content Type 1)

Letters about NF1 Care (Content Type 2)

Clinical Study ID

NCT06262113

2024P000392

AD-2022C2-24790

All Genders

Study Summary

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.

Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) 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/mynfguide

Eligibility Criteria

Inclusion

Adult Inclusion Criteria:

Currently lives in the United States (including Puerto Rico and other United Statesterritories)
Has a clinical diagnosis of neurofibromatosis 1
Does not attend an NF clinic within the Children's Tumor Foundation NF ClinicNetwork
Has an in-person, well-person visit with a primary care provider scheduled within 3months of their consent
Speaks English or Spanish

Parent/Guardian of a Child with NF1 Inclusion Criteria:

Currently lives in the United States (including Puerto Rico and other United Statesterritories)
Cares for a child (age <18 years) with a clinical diagnosis of neurofibromatosis 1
Does not attend an NF clinic within the Children's Tumor Foundation NF ClinicNetwork
Their child has an in-person, well-person visit with a primary care providerscheduled within 3 months of their consent
Speaks English or Spanish

Exclusion

Exclusion Criteria:

Only one person per household may participate in the study
Unwilling or unable to give informed consent

Study Design

Letters about NF1 Care (Content Type 1)

December 03, 2024

August 31, 2026

Study Description

Background: The majority of individuals with Neurofibromatosis 1 (NF1) in the United States lack access to specialized NF1 clinics and consequently don't receive care aligned with national recommendations. To address this gap in care, researchers are evaluating two interventions to determine which one helps people get recommended NF1-related health screenings at their annual wellness visit with a primary care provider.

Methods: Participants (adult patients or parents) who enroll in the study will complete baseline survey assessments online before their PCP visit and then be randomized to one of two groups. Both groups will be given 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.

Connect with a study center

Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Active - Recruiting

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