Parkinson's Disease Clinical Trial
— EAT MOREOfficial title:
Electronic-health Application To Measure Outcomes REmotely Clinical Trial
NCT number | NCT02418546 |
Other study ID # | 2015P000258 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | March 2018 |
Verified date | April 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | ALS Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Efficacy Measure: Survival | Vital status will be measured until the last subject last visit. | baseline to 18 months | |
Other | Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R) | Disease progression will be measured using disease-specific outcome measures (the ALSFRS-R scale). The range of the ALSFRS-R is 0-40 with higher scores indicating better function. Change in ALSFRS-R is reported as units/month. | Change over time from Baseline to 6 months | |
Other | Exploratory Efficacy Measure: Quality of Life | Quality of life will be measured using the PROMIS SF 1.1 in units. | 18 months | |
Primary | Estimated Mean Change in Weight 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. | Change over time from Baseline to 6 months | |
Secondary | Change in Calorie Intake Over Time | 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 | Change from baseline over 6 months | |
Secondary | Safety: Frequency of Adverse Events | To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. | From baseline to month 7 (one month after 6 month end of study visit) | |
Secondary | 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 |
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