Electronic-health Application To Measure Outcomes REmotely Clinical Trial
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Parkinsons Disease, Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 2015 |
| End Date: | March 2018 |
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.
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.
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.
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.
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.
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