Electronic-health Application To Measure Outcomes REmotely Clinical Trial

Not Applicable

Completed

• Conditions: Huntington's Disease; Cachexia; Neurodegenerative Disease; Weight Loss; Parkinson's Disease; Amyotrophic Lateral Sclerosis

• Registration Number: NCT02418546
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

This is a single center, randomized, open-label, placebo controlled, parallel group study. The study treatment period is approximately 6 months and observation period is approximately 7 months. There are three parallel treatment groups: in-person nutritional counseling, nutritional counseling using an e-Health App, and standard care. Subjects will be randomly assigned in a 1:1:1 ratio using a computer-generated randomization scheme. Subjects in the two intervention arms will be given caloric recommendations designed to cause weight stability or modest weight gain, depending on their current BMI and weight loss history. All participants in the intervention arms will receive counseling either in-person or remotely through the App by registered dietitians (RD) working in the Bionutrition department of the Clinical Research Center at MGH. At MGH, approximately 150 ALS subjects (50 per treatment group) will be enrolled. Approximately 75-150 PD and HD subjects will enroll.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Results First Submitted: 2019-08-14
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Results First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Adults with neurodegenerative diseases such as ALS, PD or HD with or without a history of unintentional weight loss.
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 an MGH swallowing screening tool score>5 at the time of the screening visit
5. Participants or a designated caregiver must be able to obtain home weights and communicate to their RD

Exclusion Criteria

1. Clinical evidence of unstable medical or psychiatric illness, in the investigator's judgment, which would prevent the participant from completing their assessments.
2. BMI > 35 combined with a history of cardiovascular disease; or a history of diabetes regardless of BMI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Estimated Mean Change in Weight From Baseline to 6 Months	Change over time from Baseline to 6 months	The Primary Aim is to study the feasibility and efficacy to maintain or increase body weight of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. Weights were measured in the clinic every 3 months.

Secondary Outcome Measures

Name	Time	Method
Change in Calorie Intake Over Time	Change from baseline over 6 months	Secondary aims include measuring the number of calories required to maintain or increase body weight in patients with neurodegenerative diseases. Total daily energy intake was calculated using 4 day food records at baseline, 3 months and 6 months
Safety: Frequency of Adverse Events	From baseline to month 7 (one month after 6 month end of study visit)	To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.
Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions	Baseline, 3 months and 6 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States