Improving care for underserved patients with Neurofibromatosis 1
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
NA · Massachusetts General Hospital · NCT06262113
This study is testing two different educational letters to see if they can help adults and parents of children with Neurofibromatosis 1 get better health screenings during their annual check-ups.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06262113 on ClinicalTrials.gov |
What this trial studies
This decentralized clinical trial aims to evaluate the effectiveness of two educational interventions designed to enhance evidence-based health screenings for individuals with Neurofibromatosis 1 (NF1) during their annual wellness visits with primary care providers. Participants, including adults with NF1 and parents of children with NF1, will be randomized into two groups, each receiving different letters outlining NF1 care recommendations. The study will assess the impact of these interventions on the rates of recommended health screenings. Participants will complete online surveys before and after their wellness visits, with some also participating in virtual qualitative interviews.
Who should consider this trial
Good fit: Ideal candidates include adults with a clinical diagnosis of NF1 or parents/guardians of children with NF1 who do not attend specialized NF clinics and have upcoming wellness visits with primary care providers.
Not a fit: Patients who regularly attend specialized NF clinics or do not have scheduled wellness visits with primary care providers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve access to appropriate health screenings for patients with Neurofibromatosis 1 who currently lack specialized care.
How similar studies have performed: Other studies have shown success in using educational interventions to improve healthcare outcomes, making this approach promising yet still innovative in the context of NF1.
Eligibility criteria
Show full inclusion / exclusion criteria
Adult Inclusion Criteria: * Currently lives in the United States (including Puerto Rico and other United States territories) * Has a clinical diagnosis of neurofibromatosis 1 * Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network * Has an in-person, well-person visit with a primary care provider scheduled within 3 months 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 States territories) * 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 Clinic Network * Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent * Speaks English or Spanish Exclusion Criteria: * Only one person per household may participate in the study * Unwilling or unable to give informed consent
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: 6177245321
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.
Conditions: Neurofibromatosis 1, Neurofibromatosis, NF1, Guideline, Healthcare, PCP, Parent, Pediatric