Neurofibromatosis 1
Conditions
Keywords
Neurofibromatosis, NF1, Guideline, Primary Care, Annual Care, Low Health Literacy, Healthcare, PCP
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.
Interventions
OTHERNF1 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.
OTHERPeer 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.
OTHERLetters 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.
Sponsors
Massachusetts General Hospital
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTPaulina Arias Hernandez, MSW
CONTACTAnnika Coleman, BS
PRINCIPAL_INVESTIGATORVanessa Merker, PhD
Massachusetts General Hospital
Outcome results
None listed