CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
In-Person Nutritional Counseling by a Registered Dietitian +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02418546
NCT02418546N/ACompleted

Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Massachusetts General Hospital·interventional·Posted Apr 16, 2015·Updated Apr 20, 2020

In Brief

A clinical study evaluating In-Person Nutritional Counseling by a Registered Dietitian and Nutritional counseling using an e-Health Application for Neurodegenerative Disease and 5 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsALS Association

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 16, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.2 years ago

Interventions

In-Person Nutritional Counseling by a Registered Dietitianbehavioral

Nutritional counseling using an e-Health Applicationbehavioral