Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04051333
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.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We have designed a mobile health app to provide nutritional counseling and to measure disease outcomes both through self-reported questionnaires and through passive data collection.
Time frame: Change over time over 6 months
Patient Reported Global Health Questionnaire where the higher the T score the better
Time frame: Change over time over 6 months
The ALSFRS-R total score ranges from 0-40 with higher scores better
Massachusetts General Hospital
Other
Acronym: EAT MORE2
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