The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2) (EAT MORE2)
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|ClinicalTrials.gov Identifier: NCT04051333|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment|
|Amyotrophic Lateral Sclerosis||Device: ALS Nutrition App (MyDataHelps platform)|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)|
|Actual Study Start Date :||March 30, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Device: ALS Nutrition App (MyDataHelps platform)
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.
- Patient Reported Outcome Measurement Information System Short Form v1.0 [ Time Frame: Change over time over 6 months ]Patient Reported Global Health Questionnaire where the higher the T score the better
- ALS Functional Rating Scale-Revised [ Time Frame: Change over time over 6 months ]The ALSFRS-R total score ranges from 0-40 with higher scores better
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051333
|Contact: Mansi Sharma||617.643.2400||mghALSapp@partners.org|
|Contact: Anne-Marie Wills, MD MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Mansi Sharma, BA 617-643-2400 mghALSapp@partners.org|