Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04051333
Brief Summary:
This is phase IIa feasibility and tolerability study of a mobile health (mHealth) application designed to study the effects of remote dietary counseling on disease progression and quality of life. The study will consist of two phases: Part I will consist of building and beta-testing the ALS Nutrition app and Part II will consist of enrolling a larger cohort of users into the app.
Detailed Description:
The investigators' prior work has shown that nutrition is an important modifiable prognostic factor for ALS disease progression and survival. In the recently completed E-Health Application To Measure Outcomes Remotely (EAT MORE) clinical trial (sponsored by the ALS Association), the investigators found that nutritional counseling supported by a mobile health (mHealth) app was associated with 0.5 points/month slower ALSFRS-R progression (p=0.17) and improved quality of life (p=0.09).
The investigators are now designing an ALS-specific app that can be used by everyone with ALS, including those who do not live near ALS Centers. The app would help to address gaps in the delivery of ALS care by providing nutritional counseling, helping patients to manage and track their disease symptoms, and communicating with their providers. After the initial design has been tested by a group of NEALS patients and their caregivers, the study will advertise the app widely to recruit a larger group of ALS patients to measure nutrition and outcomes.
Study:
NCT04051333
Study Brief:
Protocol Section:
NCT04051333