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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
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Device: ALS Nutrition App (MyDataHelps platform)

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with ALS without dysphagia, diabetes or cardiovascular disease
Criteria

Inclusion Criteria:

  1. Participants with a diagnosis of ALS (self-reported)
  2. Male or female subjects aged 18 years or older.
  3. Participants must be capable of providing informed consent and complying with trial procedures.
  4. Participants must have access to an iOS or Android device to allow the to download the apps.

Exclusion criteria:

  1. Use of a feeding tube (G-tube or J-tube)
  2. BMI>30 kg/m2 regardless of weight loss history
  3. A history of cardiovascular disease (stroke, myocardial infarction, peripheral vascular disease)
  4. A history of diabetes (self-reported)

Information from the National Library of Medicine

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


Contacts
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Contact: Mansi Sharma 617.643.2400 mghALSapp@partners.org
Contact: Anne-Marie Wills, MD MPH 6176432643 awills@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mansi Sharma, BA    617-643-2400    mghALSapp@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
ALS Association
Publications:
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Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04051333    
Other Study ID Numbers: 2019P001649
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases