Trial Outcomes & Findings for Electronic-health Application To Measure Outcomes REmotely Clinical Trial (NCT NCT02418546)
NCT ID: NCT02418546
Last Updated: 2020-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Change over time from Baseline to 6 months
Results posted on
2020-04-20
Participant Flow
Participant milestones
| Measure |
In-Person Nutritional Counseling
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
26
|
|
Overall Study
COMPLETED
|
19
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electronic-health Application To Measure Outcomes REmotely Clinical Trial
Baseline characteristics by cohort
| Measure |
In-Person Nutritional Counseling
n=26 Participants
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
n=26 Participants
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
n=26 Participants
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
ALS Functional Rating Scale-Revised
|
34.9 Total score in points
STANDARD_DEVIATION 6.67 • n=5 Participants
|
37.4 Total score in points
STANDARD_DEVIATION 6.19 • n=7 Participants
|
36.7 Total score in points
STANDARD_DEVIATION 5.36 • n=5 Participants
|
36.4 Total score in points
STANDARD_DEVIATION 6.21 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change over time from Baseline to 6 monthsPopulation: Please note that these are Parameter Estimates rather than "means"
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.
Outcome measures
| Measure |
In-Person Nutritional Counseling
n=26 Participants
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
n=26 Participants
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
n=26 Participants
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
|---|---|---|---|
|
Estimated Mean Change in Weight From Baseline to 6 Months
|
-0.1 kg
Interval -2.1 to 2.0
|
-0.2 kg
Interval -2.4 to 2.1
|
-1.2 kg
Interval -3.2 to 0.7
|
SECONDARY outcome
Timeframe: Change from baseline over 6 monthsSecondary 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 18 monthsVital status will be measured until the last subject last visit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change over time from Baseline to 6 monthsPopulation: Change over time of continuous, longitudinal measures was analyzed using a shared-baseline, mixed effect model with fixed effects for visit and an interaction between post-baseline visit and study arm and with a random slope and intercept for each subject with unstructured covariance.
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.
Outcome measures
| Measure |
In-Person Nutritional Counseling
n=26 Participants
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
n=26 Participants
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
n=26 Participants
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
|---|---|---|---|
|
Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R)
|
-5.8 units per month
Interval -8.2 to -3.4
|
-2.6 units per month
Interval -5.1 to -0.1
|
-5.2 units per month
Interval -7.6 to -2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsQuality of life will be measured using the PROMIS SF 1.1 in units.
Outcome measures
Outcome data not reported
Adverse Events
In-Person Nutritional Counseling
Serious events: 4 serious events
Other events: 9 other events
Deaths: 4 deaths
E-Health App for Nutritional Counseling
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Standard Care
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
In-Person Nutritional Counseling
n=26 participants at risk
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
n=26 participants at risk
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
n=26 participants at risk
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Deep Venous Thrombosis
|
7.7%
2/26 • Number of events 2 • 7 months
|
0.00%
0/26 • 7 months
|
0.00%
0/26 • 7 months
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Number of events 2 • 7 months
|
0.00%
0/26 • 7 months
|
7.7%
2/26 • Number of events 2 • 7 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
|
Nervous system disorders
Lacunar Stroke
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's Sarcoma
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
Other adverse events
| Measure |
In-Person Nutritional Counseling
n=26 participants at risk
Participants in the in-person nutritional counseling arm will meet with a Registered Dietitian at every clinic visit and will also receive regular phone calls to monitor weight and food intake. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level.
In-Person Nutritional Counseling by a Registered Dietitian
|
E-Health App for Nutritional Counseling
n=26 participants at risk
Participants randomized to the e-Health App arm with receive nutritional counseling using the e-Health Application. Participants will enter weights at home and complete electronic food records using the App. Participants' individual dietary needs will be calculated using baseline calorie consumption, weight history, disease status and current activity level. Participants will receive these calorie recommendations through the Application.
Nutritional counseling using an e-Health Application
|
Standard Care
n=26 participants at risk
Participants are allowed to receive all usual treatments and medications. Participation in other research studies is allowed.
|
|---|---|---|---|
|
Gastrointestinal disorders
sialorrhea
|
15.4%
4/26 • Number of events 4 • 7 months
|
0.00%
0/26 • 7 months
|
7.7%
2/26 • Number of events 2 • 7 months
|
|
General disorders
Fatigue
|
0.00%
0/26 • 7 months
|
7.7%
2/26 • Number of events 2 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
|
Injury, poisoning and procedural complications
Falls
|
26.9%
7/26 • Number of events 8 • 7 months
|
34.6%
9/26 • Number of events 13 • 7 months
|
34.6%
9/26 • Number of events 13 • 7 months
|
|
Gastrointestinal disorders
Choking
|
3.8%
1/26 • Number of events 1 • 7 months
|
0.00%
0/26 • 7 months
|
7.7%
2/26 • Number of events 2 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26 • 7 months
|
3.8%
1/26 • Number of events 1 • 7 months
|
7.7%
2/26 • Number of events 2 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place