Online program providing personalized NF1 care letters plus videos or peer navigator support for adults with low health literacy
Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy
This study will test whether giving adults with NF1 and low health literacy personalized care letters plus either short, plain-language videos or a call with a trained peer navigator helps them better understand NF1 symptoms and care before their primary care visit.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07233408 on ClinicalTrials.gov |
What this trial studies
Adults with Neurofibromatosis type 1 and low health literacy are enrolled from across the U.S. and complete online baseline surveys. Participants are randomized to receive either brief, plain-language NF1 educational videos or a scheduled call with a trained NF1 peer navigator, and all receive personalized NF1 care letters for themselves and their clinicians. After attending their scheduled primary care wellness visit participants complete an online follow-up survey, and a small subset will be invited for a virtual qualitative interview. All activities are conducted remotely and no in-person visits to Massachusetts General Hospital are required.
Who should consider this trial
Good fit: Adults (≥18) in the United States with a clinical diagnosis of NF1 who speak English, are identified as having low health literacy, and have an in-person primary care wellness visit scheduled within three months are ideal candidates.
Not a fit: People who are not English-speaking, are too cognitively impaired to complete study questionnaires, do not have a scheduled wellness visit within three months, or who already have adequate health literacy may not receive benefit from these interventions.
Why it matters
Potential benefit: If successful, this approach could help adults with NF1 and low health literacy better understand care recommendations and improve adherence to recommended screenings.
How similar studies have performed: Peer navigator programs and simplified educational materials have improved understanding and care engagement in other chronic conditions, but these approaches are relatively novel for NF1.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Vanessa Merker, PhD — Massachusetts General Hospital
- Study coordinator: Paulina Arias Hernandez, MSW
- Email: pahernandez@mgb.org
- Phone: 617-724-5321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.