Trial Outcomes & Findings for Electronic Strategies for Tailored Exercise to Prevent FallS (NCT NCT04993781)
NCT ID: NCT04993781
Last Updated: 2026-07-08
Results Overview
To determine the effect of the eSTEPS intervention on all falls per 100 patient years
COMPLETED
NA
11945 participants
Up to 23 months
2026-07-08
Participant Flow
Unit of analysis: Practice sites
Participant milestones
| Measure |
eSTEPS Clinical Decision Support
Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.
|
Usual Care
Usual primary care practices regarding exercise-related fall prevention planning
|
|---|---|---|
|
Overall Study
STARTED
|
5681 12
|
6264 12
|
|
Overall Study
COMPLETED
|
5221 11
|
5841 11
|
|
Overall Study
NOT COMPLETED
|
460 1
|
423 1
|
Reasons for withdrawal
| Measure |
eSTEPS Clinical Decision Support
Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.
|
Usual Care
Usual primary care practices regarding exercise-related fall prevention planning
|
|---|---|---|
|
Overall Study
Death
|
433
|
402
|
|
Overall Study
Lost to Follow-up
|
27
|
21
|
Baseline Characteristics
The rows are showing the data broken down by sex (male or female)
Baseline characteristics by cohort
| Measure |
eSTEPS Clinical Decision Support
n=5681 Participants
Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.
|
Usual Care
n=6264 Participants
Usual primary care practices regarding exercise-related fall prevention planning
|
Total
n=11945 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.7 Years
STANDARD_DEVIATION 7.5 • n=5681 Participants
|
77.3 Years
STANDARD_DEVIATION 7.4 • n=6264 Participants
|
77.1 Years
STANDARD_DEVIATION 7.4 • n=11945 Participants
|
|
Sex: Female, Male
Female
|
3853 Participants
n=5681 Participants • The rows are showing the data broken down by sex (male or female)
|
4191 Participants
n=6264 Participants • The rows are showing the data broken down by sex (male or female)
|
8044 Participants
n=11945 Participants • The rows are showing the data broken down by sex (male or female)
|
|
Sex: Female, Male
Male
|
1828 Participants
n=5681 Participants • The rows are showing the data broken down by sex (male or female)
|
2073 Participants
n=6264 Participants • The rows are showing the data broken down by sex (male or female)
|
3901 Participants
n=11945 Participants • The rows are showing the data broken down by sex (male or female)
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
480 Participants
n=5681 Participants
|
567 Participants
n=6264 Participants
|
1047 Participants
n=11945 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4987 Participants
n=5681 Participants
|
5436 Participants
n=6264 Participants
|
10423 Participants
n=11945 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
214 Participants
n=5681 Participants
|
261 Participants
n=6264 Participants
|
475 Participants
n=11945 Participants
|
|
Race/Ethnicity, Customized
White
|
4436 Participants
n=5681 Participants
|
4992 Participants
n=6264 Participants
|
9428 Participants
n=11945 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
585 Participants
n=5681 Participants
|
360 Participants
n=6264 Participants
|
945 Participants
n=11945 Participants
|
|
Race/Ethnicity, Customized
Other
|
131 Participants
n=5681 Participants
|
299 Participants
n=6264 Participants
|
430 Participants
n=11945 Participants
|
|
Race/Ethnicity, Customized
Missing
|
529 Participants
n=5681 Participants
|
613 Participants
n=6264 Participants
|
1142 Participants
n=11945 Participants
|
|
Falls Self-efficacy (fear of falling)
|
8.6 Score
STANDARD_DEVIATION 1.6 • n=351 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
8.8 Score
STANDARD_DEVIATION 1.4 • n=308 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
8.7 Score
STANDARD_DEVIATION 1.5 • n=659 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
|
Self-efficacy for exercise
|
6.9 Score
STANDARD_DEVIATION 2.4 • n=349 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
7.3 Score
STANDARD_DEVIATION 2.2 • n=307 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
7.1 Score
STANDARD_DEVIATION 2.3 • n=656 Participants • This measures was collected from a pre-planned subsample of participants, so there are fewer participants than in the overall trial
|
PRIMARY outcome
Timeframe: Up to 23 monthsTo determine the effect of the eSTEPS intervention on all falls per 100 patient years
Outcome measures
| Measure |
eSTEPS Intervention
n=5681 Participants
Intervention group that was provided access to the eSTEPS fall exercise prevention clinical decision support tool
|
Control Group
n=6264 Participants
Received usual care
|
|---|---|---|
|
To Determine the Effect of the eSTEPS Intervention on the Rate of Falls
|
19.3 Falls per 100 person years
Interval 18.6 to 20.1
|
21.2 Falls per 100 person years
Interval 20.2 to 22.1
|
SECONDARY outcome
Timeframe: Change from initial assessment to 6 monthsPopulation: This outcome was collected on a pre-planned randomly selected subgroup of participants who provided consent for telephone interviews
Falls self-efficacy (fear of falling) will be measured using the Modified Falls Efficacy Scale (mFES). This scale assesses confidence with completing a list of activities without falling and contains 14 items each measured on a scale of 0 to 10. 0 means "not confident at all", 5 means "fairly confident", and 10 means "completely confident." he total score is the average of all of the item scores and ranges from zero to ten. A higher score reflects more confidence and less fear of falling. Participants are classified as either fearful (MFES score \< 8) or not fearful (MFES greater than or equal to 8). The total score range is 0 to 10.
Outcome measures
| Measure |
eSTEPS Intervention
n=300 Participants
Intervention group that was provided access to the eSTEPS fall exercise prevention clinical decision support tool
|
Control Group
n=273 Participants
Received usual care
|
|---|---|---|
|
To Determine the Effect of the eSTEPS Intervention on Falls Self-efficacy (Fear of Falling)
|
0.0 Change in Mean Score
Standard Deviation 1.1
|
-0.04 Change in Mean Score
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Change from initial visit to 6 monthsPopulation: This outcome was collected on a pre-planned randomly selected subgroup of participants who provided consent for telephone interviews
Self-efficacy for exercise will be measured using the Self-Efficacy for Exercise (SEE) Scale. This scale consists of nine situations that may affect participation in exercise and ask participants to describe their current level of confidence that they could exercise 3 times a week for 20 minutes each time. 0 means "not confident", 5 means "fairly confident", and 10 means "very confident." The total score for the SEE scale is calculated by taking the numerical ratings for each statement and dividing by number of responses. The score indicates the strength of self-efficacy for exercise expectations. The higher the average score, the greater the participant's self-efficacy for exercise. The total score range is 0 to 10.
Outcome measures
| Measure |
eSTEPS Intervention
n=300 Participants
Intervention group that was provided access to the eSTEPS fall exercise prevention clinical decision support tool
|
Control Group
n=273 Participants
Received usual care
|
|---|---|---|
|
To Determine the Effect of the eSTEPS Intervention on Self-efficacy for Exercise
|
-0.15 Change in Mean score
Standard Deviation 2.1
|
-0.35 Change in Mean score
Standard Deviation 2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 23 monthsTo explore the effect of the esteps intervention on the rate of death (mortality) in the intervention versus control groups
Outcome measures
| Measure |
eSTEPS Intervention
n=5681 Participants
Intervention group that was provided access to the eSTEPS fall exercise prevention clinical decision support tool
|
Control Group
n=6264 Participants
Received usual care
|
|---|---|---|
|
To Explore the Effect of the eSTEPS Intervention on Death
|
5.9 Death per 100 person years
Interval 5.0 to 7.0
|
5.6 Death per 100 person years
Interval 5.1 to 6.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 23 monthsTo determine the effect of the eSTEPS intervention on the rate of fall injuries calculated as fall-related injuries per 100 person years
Outcome measures
| Measure |
eSTEPS Intervention
n=5681 Participants
Intervention group that was provided access to the eSTEPS fall exercise prevention clinical decision support tool
|
Control Group
n=6264 Participants
Received usual care
|
|---|---|---|
|
To Determine the Effect of the eSTEPS Intervention the Rate of Fall-related Injuries
|
15.7 Fall-related injuries /100 person years
Interval 15.0 to 16.5
|
16.7 Fall-related injuries /100 person years
Interval 16.1 to 17.4
|
Adverse Events
eSTEPS Clinical Decision Support
Usual Care
Serious adverse events
| Measure |
eSTEPS Clinical Decision Support
n=5681 participants at risk
Use of clinical decision support to assist in exercise-related fall prevention care planning will be compared to usual care.
|
Usual Care
n=6264 participants at risk
Usual primary care practices regarding exercise-related fall prevention planning
|
|---|---|---|
|
General disorders
Hospitalization and/or death
|
31.1%
1767/5681 • Number of events 4130 • Baseline to 23 months
In this pragmatic trial, only serious adverse were monitored
|
28.5%
1787/6264 • Number of events 4073 • Baseline to 23 months
In this pragmatic trial, only serious adverse were monitored
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place