50 Participants Needed

Online Platform for Neurofibromatosis

PA
AC
Overseen ByAnnika Coleman, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with Neurofibromatosis 1 (NF1) better understand their condition and care options. Researchers seek to evaluate the effectiveness and user-friendliness of two approaches: educational videos about NF1 and support from a peer navigator, who guides and advises others with the same condition. Participants will also receive personalized care letters for themselves and their doctors. The trial seeks adults in the U.S. with NF1, low health literacy, and an upcoming wellness visit with their primary care provider.

As an unphased trial, this study offers participants a unique opportunity to gain valuable insights and support in managing their condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational support rather than medication changes.

What prior data suggests that these approaches are safe for NF1 patients?

A previous study on the PEERS intervention, similar to the Peer Navigator program, showed promise in helping teenagers with Neurofibromatosis Type 1 (NF1) improve their social skills. This suggests that the Peer Navigator might also be helpful and safe for adults. Reports have not indicated any serious side effects from these peer support programs.

Regarding the NF1 Educational Videos, direct safety data is unavailable. However, educational videos are generally considered safe as they provide information rather than medical treatment. These videos aim to help people understand their condition better, potentially improving how they manage their health.

Overall, both interventions are non-invasive and have not shown any safety concerns in similar contexts. This study focuses on educating and supporting people with NF1 rather than testing a new drug or medical procedure.12345

Why are researchers excited about this trial?

Researchers are excited about the Online Platform for Neurofibromatosis because it introduces innovative methods like NF1 Educational Videos and a Peer Navigator to support individuals with NF1. Unlike traditional treatments that focus primarily on medical interventions, this platform emphasizes education and peer support, helping patients understand their condition better and connect with others facing similar challenges. These approaches can empower patients by providing easily accessible information and a community network, potentially enhancing their overall quality of life and self-management skills.

What evidence suggests that this trial's treatments could be effective for improving understanding of NF1 symptoms and care?

This trial will compare different methods to enhance understanding of NF1 care. Research has shown that educational videos, one method tested in this trial, can simplify complex health information. Specifically, one study found that videos in a telehealth program improved social skills in teenagers with NF1, suggesting that videos might also enhance adults' understanding of NF1 care.

For the peer navigator approach, another method tested in this trial, earlier studies show it can assist people with NF1 in understanding and managing their condition. Peer navigators, trained guides who offer support, have successfully taught social skills to teenagers with NF1. This success indicates they could also help adults manage their healthcare more effectively. Both methods aim to make NF1 care information more accessible for those with limited health knowledge.56789

Who Is on the Research Team?

VM

Vanessa Merker, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults in the U.S. with Neurofibromatosis 1 (NF1) who have low health literacy and an upcoming annual wellness visit with their primary care provider. Eligibility will be determined through a prescreening survey.

Inclusion Criteria

Speaks English
Has low health literacy as ascertained by standardized instruments
Has an in-person, well-person visit with their primary care provider (PCP) scheduled within the 3 months following their consent
See 3 more

Exclusion Criteria

Unwilling or unable to give informed consent
I am able to understand and complete study questionnaires.
Was enrolled in or is the parent or guardian of a participant enrolled in randomized clinical trial NCT06262113

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline survey assessments online before their PCP visit

1 week

Intervention

Participants are randomized to receive either NF1 educational videos or a call with an NF1 peer navigator, along with personalized NF1 care letters

2 weeks

Follow-up

Participants complete an online follow-up survey and a small subsample participates in a virtual qualitative interview

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Letters about NF1 Care
  • NF1 Educational Videos
  • Peer Navigator
Trial Overview The study compares two methods to help NF1 patients understand their condition better: one group receives educational videos, while another gets personalized care letters and a call from an NF1 peer navigator.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Peer NavigatorExperimental Treatment2 Interventions
Group II: NF1 Educational VideosExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Study Details | NCT07233408 | Tailoring an Online ...To address this gap, researchers are evaluating two interventions to promote understanding of NF1 care within adults with low health literacy.
NF Forum 2020: The Impact of NF1 on Relationships ...This NF Forum virtual session was presented on Sept 17, 2020, and discussed the impact of neurofibromatosis on school and learning, ...
Visual spatial learning outcomes for clinical trials in ...We leveraged a large, international cognitive study in affected children with NF1 treated with lovastatin to assess spatial learning using the “Arena Maze”.
Pilot study of the effectiveness of a telehealth group for ...In this pilot study, the effectiveness of a 14-week telehealth PEERS® intervention with nineteen adolescents with NF1 (Mage=13.79 years, SD = ...
Pilot study of the effectiveness of a telehealth group for ...The PEERS® intervention is promising to support the social and friendship skills of adolescents with NF1 who have social difficulties.
Learning with NF1LEARNING with NF1. About half of those diagnosed with neurofibromatosis type 1 (NF1) experience some form of learning disability. Imagine how confusing.
10 Things Everyone Should Know About Their NF1The NF Network invites you to join us for an NF1 webinar "10 Things Everyone Should Know About Their NF1" presented by Doug Stewart, MD, ...
Study Details | NCT07233408 | Tailoring an Online ...To address this gap, researchers are evaluating two interventions to promote understanding of NF1 care within adults with low health literacy.
in Neurofibromatosis Type 1,This educational activity may contain discussions of published and/or investigational uses of agents that are not indicated by the FDA.
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