Trial Outcomes & Findings for Low Indexes of Metabolism - Information to Teams (LIMIT) (NCT NCT02476578)
NCT ID: NCT02476578
Last Updated: 2020-04-09
Results Overview
Impact on overall-survival
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8584 participants
Primary outcome timeframe
1 year
Results posted on
2020-04-09
Participant Flow
Some of the participants may fit more than one criterion, as explained in the Eligibility section. Hence 7 subgroups are created: A) Fit only alert 1. B) Fit only alert 2. C) Fit only alert 3. D) Fit both alert 1. and alert 2. E) Fit both alert 1. and alert 3. F) Fit both alert 2. and alert 3. G) Fit all alerts: 1. , 2. and 3.
Participant milestones
| Measure |
Intervention Email
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
|
Control
No email is sent.
|
|---|---|---|
|
Overall Study
STARTED
|
4310
|
4274
|
|
Overall Study
Died Before Email Was Sent
|
35
|
43
|
|
Overall Study
Left Before End of Trial
|
6
|
13
|
|
Overall Study
COMPLETED
|
4269
|
4218
|
|
Overall Study
NOT COMPLETED
|
41
|
56
|
Reasons for withdrawal
| Measure |
Intervention Email
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
|
Control
No email is sent.
|
|---|---|---|
|
Overall Study
Died before Email was sent (<9.11.2015)
|
35
|
43
|
|
Overall Study
Lost to Follow-up
|
6
|
13
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Email
n=4269 Participants
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
|
Control
n=4218 Participants
No email is sent.
|
Total
n=8487 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.6 years
STANDARD_DEVIATION 4.7 • n=4269 Participants
|
80.8 years
STANDARD_DEVIATION 4.9 • n=4218 Participants
|
80.7 years
STANDARD_DEVIATION 4.8 • n=8487 Participants
|
|
Sex: Female, Male
Female
|
2484 Participants
n=4269 Participants
|
2445 Participants
n=4218 Participants
|
4929 Participants
n=8487 Participants
|
|
Sex: Female, Male
Male
|
1785 Participants
n=4269 Participants
|
1773 Participants
n=4218 Participants
|
3558 Participants
n=8487 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
4269 participants
n=4269 Participants
|
4218 participants
n=4218 Participants
|
8487 participants
n=8487 Participants
|
|
Body Mass Index (BMI)
|
28.7 kg/m^2
STANDARD_DEVIATION 5.9 • n=4269 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.9 • n=4218 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.9 • n=8487 Participants
|
|
HbA1c% Mean (Standard Deviation)
|
6.51 %
STANDARD_DEVIATION 1.05 • n=3185 Participants • Baseline HbA1c% in known for all participants in groups B,D,F,G. However, it is known only for some participants in groups A,C,E. (See: Eligibility section)
|
6.46 %
STANDARD_DEVIATION 1.00 • n=3117 Participants • Baseline HbA1c% in known for all participants in groups B,D,F,G. However, it is known only for some participants in groups A,C,E. (See: Eligibility section)
|
6.49 %
STANDARD_DEVIATION 1.02 • n=6302 Participants • Baseline HbA1c% in known for all participants in groups B,D,F,G. However, it is known only for some participants in groups A,C,E. (See: Eligibility section)
|
|
Total Cholesterol Mean (Standard Deviation)
|
154.61 mg/dL
STANDARD_DEVIATION 33.88 • n=4262 Participants • Baseline Cholesterol is known for all participants in groups C,E,F,G. However, it is known only for some participants in groups A,B,D. See: Eligibility section.
|
154.23 mg/dL
STANDARD_DEVIATION 33.60 • n=4209 Participants • Baseline Cholesterol is known for all participants in groups C,E,F,G. However, it is known only for some participants in groups A,B,D. See: Eligibility section.
|
154.42 mg/dL
STANDARD_DEVIATION 33.74 • n=8471 Participants • Baseline Cholesterol is known for all participants in groups C,E,F,G. However, it is known only for some participants in groups A,B,D. See: Eligibility section.
|
PRIMARY outcome
Timeframe: 1 yearImpact on overall-survival
Outcome measures
| Measure |
Intervention Email
n=4269 Participants
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
|
Control
n=4218 Participants
No email is sent.
|
|---|---|---|
|
Death From Any Cause
|
285 Participants
|
245 Participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage of patients evaluated by a nurse and counseled by a dietitian
Outcome measures
| Measure |
Intervention Email
n=4269 Participants
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Email: Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
|
Control
n=4218 Participants
No email is sent.
|
|---|---|---|
|
Impact on Evaluation Rate
|
3387 Participants
|
3337 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected
Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data were not collected.
A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Email
Serious events: 0 serious events
Other events: 0 other events
Deaths: 285 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 245 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place