Neurofibromatosis 1NCT07233408
Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy
A study testing NF1 Educational Videos, Peer Navigator and Letters about NF1 Care in people with Neurofibromatosis 1, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurofibromatosis 1
- What is being tested?
- NF1 Educational Videos, Peer Navigator and Letters about NF1 Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Paulina Arias Hernandez, MSW, 617-724-5321, pahernandez@mgb.org
Annika Coleman, BS, 857-282-2167, acoleman0@mgh.harvard.edu
About this study
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
Read the 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.
- Conditions
- Neurofibromatosis 1
- Being tested
- NF1 Educational Videos, Peer Navigator, Letters about NF1 Care
- Keywords
- Neurofibromatosis, NF1, Guideline, Primary Care, Annual Care, Low Health Literacy, Healthcare, PCP
- Medical subject headings
- Neurofibromatosis 1, Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NF1 Educational VideosOther
Participants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit.
Peer NavigatorOther
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.
Letters about NF1 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NF1 Educational Videos | Experimental | Not described Receives: Other: NF1 Educational Videos; Other: Letters about NF1 Care |
| Peer Navigator | Experimental | Not described Receives: Other: Peer Navigator; Other: Letters about NF1 Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide
- 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)
Measured: 2 weeks after PCP visit
Secondary outcomes (2)
Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: 2 weeks after PCP visit
Telehealth Usability Questionnaire (TUQ)
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.
Measured: 2 weeks after PCP visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start28 Dec 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Vanessa Merker, PhD, Massachusetts General Hospital
- Investigators
- Vanessa Merker, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233408
- Sponsor's protocol ID
- 2024P002819
- Other IDs
- HT9425-23-1-0457
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merker VL, Knight P, Radtke HB, Yohay K, Ullrich NJ, Plotkin SR, Jordan JT. Awareness and agreement with neurofibromatosis care guidelines among U.S. neurofibromatosis specialists. Orphanet J Rare Dis. 2022 Feb 10;17(1):44. doi: 10.1186/s13023-022-02196-x.
PubMed 35144646Merker VL, McDannold S, Riklin E, Talaei-Khoei M, Sheridan MR, Jordan JT, Plotkin SR, Vranceanu AM. Health literacy assessment in adults with neurofibromatosis: electronic and short-form measurement using FCCHL and Health LiTT. J Neurooncol. 2018 Jan;136(2):335-342. doi: 10.1007/s11060-017-2657-8. Epub 2017 Nov 8.
PubMed 29119424
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy
- ClinicalTrials.gov ID
- NCT07233408
- Acronym / sponsor ID
- 2024P002819
- Conditions
- Neurofibromatosis 1
- Keywords
- Neurofibromatosis, NF1, Guideline, Primary Care, Annual Care, Low Health Literacy, Healthcare, PCP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 28 Dec 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NF1 Educational Videos | Experimental | Other: NF1 Educational Videos, Other: Letters about NF1 Care |
| Peer Navigator | Experimental | Other: Peer Navigator, Other: Letters about NF1 Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NF1 Educational VideosParticipants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit. | Other | NF1 Educational Videos |
| Peer NavigatorParticipants 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 | Peer Navigator |
| Letters about NF1 CareParticipants 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. | Other | NF1 Educational Videos, Peer Navigator |
Primary outcome
Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide
Time frame: 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)
2 secondary outcomes
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 2 weeks after PCP visit
Telehealth Usability Questionnaire (TUQ)
Time frame: 2 weeks after PCP visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 35144646Merker VL, Knight P, Radtke HB, Yohay K, Ullrich NJ, Plotkin SR, Jordan JT. Awareness and agreement with neurofibromatosis care guidelines among U.S. neurofibromatosis specialists. Orphanet J Rare Dis. 2022 Feb 10;17(1):44. doi: 10.1186/s13023-022-02196-x.
- Background: PubMed 29119424Merker VL, McDannold S, Riklin E, Talaei-Khoei M, Sheridan MR, Jordan JT, Plotkin SR, Vranceanu AM. Health literacy assessment in adults with neurofibromatosis: electronic and short-form measurement using FCCHL and Health LiTT. J Neurooncol. 2018 Jan;136(2):335-342. doi: 10.1007/s11060-017-2657-8. Epub 2017 Nov 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Merker, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NF1 Educational Videos, Peer Navigator and Letters about NF1 Care in people with Neurofibromatosis 1, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulina Arias Hernandez, MSW (617-724-5321, pahernandez@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide (time frame: 2 weeks after PCP visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.