Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Massachusetts General Hospital
Boston, Massachusetts, United States
Full Study Summary:
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.
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 Sponsor:
Massachusetts General Hospital
Estimated Enrollment:
87
Estimated Study Start Date:
03 / 30 / 2020
Estimated Study Completion Date:
12 / 31 / 2021
Posting Last Modified Date:
02 / 08 / 2022
Date Study Added to neals.org:
08 / 09 / 2019
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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)
Massachusetts General Hospital
Boston, Massachusetts
02114
United States