Electronic-health Application To Measure Outcomes REmotely Clinical Trial
Completed · Not applicable
Conditions studied: Neurodegenerative Disease, Weight Loss, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Huntington's Disease, Cachexia
In brief
This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.
Key facts
- Study ID
- NCT02418546
- Run by
- Massachusetts General Hospital
- People needed
- 78
- Starts
- 2015-04-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2020-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
- Male or female subjects aged 18 years or older.
- Participants must be capable of providing informed consent and complying with trial procedures.
- Participants must have an MGH swallowing screening tool score>5 at the time of the screening visit
- Participants or a designated caregiver must be able to obtain home weights and communicate to their RD
You may not qualify if…
- Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
- BMI > 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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