Trial · NCT02475850

Strategies to Reduce Injuries and Develop Confidence in Elders

NCT02475850, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2021-03-03

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Strategies to Reduce Injuries and Develop Confidence in Elders. Trials, record NCT02475850. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02475850

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Strategies to Reduce Injuries and Develop Confidence in Elders
NCT number: NCT02475850
Status: Completed
Phases: Phase 3
Enrollment: 5,451 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Accidental Falls, Wounds and Injuries
Interventions: Evidence-based tailored fall prevention, Usual care
First posted: 2015-06-19
Last updated: 2021-03-03
Results first posted: 2021-03-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	First Adjudicated Serious Fall-Related Injury	Enrollment through last completed follow-up or death interview (max 44 months)	Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.
Secondary	First Self-reported Fall-related Injury	Enrollment through last completed follow-up or death interview (max 44 months)	Number of first self-reported fall-related injuries per 100 per years of follow-up
Secondary	Time to Self-reported Falls	these data were not collected	\\ data for this outcome was not collected
Secondary	Physical Function	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores	Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
Secondary	Disability	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores	Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
Secondary	Anxiety	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.
Secondary	Depression	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.
Secondary	Fear of Falling	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	First Adjudicated Serious Fall-Related Injury	Enrollment through last completed follow-up or death interview (max 44 months)		events per 100 person years of follow-up	NUMBER
SECONDARY	First Self-reported Fall-related Injury	Enrollment through last completed follow-up or death interview (max 44 months)		events per 100 person years of follow-up	NUMBER
SECONDARY	Time to Self-reported Falls	these data were not collected	These data were not collected
SECONDARY	Physical Function	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores	subsample selected for well-being measures with completed baseline LL-FDI	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Disability	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores	subsample selected for well-being measures with completed baseline LL-FDI	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Anxiety	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	subsample selected for well-being measures and with completed baseline PROMIS Anxiety	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Depression	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	subsample selected for well-being measures and with completed baseline PROMIS dep	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Fear of Falling	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.	subsample selected for well-being measures and with completed baseline FES	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
First Adjudicated Serious Fall-Related Injury	Intervention - Fall Prevention Standard of Care	4.87	95% Confidence Interval 4.31 to 5.43	events per 100 person years of follow-up
First Adjudicated Serious Fall-Related Injury	Control	5.34	95% Confidence Interval 4.55 to 6.13	events per 100 person years of follow-up
First Self-reported Fall-related Injury	Intervention - Fall Prevention Standard of Care	25.64	99% Confidence Interval 24.19 to 27.08	events per 100 person years of follow-up
First Self-reported Fall-related Injury	Control	28.62	99% Confidence Interval 26.53 to 30.72	events per 100 person years of follow-up
Physical Function	Intervention - Fall Prevention Standard of Care	58.45	Standard Error 0.48	units on a scale
Physical Function	Control	57.73	Standard Error 0.51	units on a scale
Disability	Intervention - Fall Prevention Standard of Care	55.16	Standard Error 0.63	units on a scale
Disability	Control	54.57	Standard Error 0.67	units on a scale
Anxiety	Fall Prevention Standard of Care	11.63	Standard Error 0.29	units on a scale
Anxiety	Control	12.53	Standard Error 0.30	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention - Fall Prevention Standard of Care	2,802
Overall Study	STARTED	Control	2,649
Overall Study	COMPLETED	Intervention - Fall Prevention Standard of Care	2,209
Overall Study	COMPLETED	Control	2,165
Overall Study	NOT COMPLETED	Intervention - Fall Prevention Standard of Care	593
Overall Study	NOT COMPLETED	Control	484

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	hospitalization	Blood and lymphatic system disorders	Intervention - Fall Prevention Standard of Care	24	2,802	29
serious	hospitalization	Blood and lymphatic system disorders	Control	29	2,649	34
serious	hospitalization	Cardiac disorders	Intervention - Fall Prevention Standard of Care	199	2,802	270
serious	hospitalization	Cardiac disorders	Control	199	2,649	259
serious	hospitalization	Congenital, familial and genetic disorders	Intervention - Fall Prevention Standard of Care	1	2,802	1
serious	hospitalization	Congenital, familial and genetic disorders	Control	2	2,649	2
serious	hospitalization	Ear and labyrinth disorders	Intervention - Fall Prevention Standard of Care	7	2,802	7
serious	hospitalization	Ear and labyrinth disorders	Control	3	2,649	3
serious	hospitalization	Endocrine disorders	Intervention - Fall Prevention Standard of Care	7	2,802	7
serious	hospitalization	Endocrine disorders	Control	7	2,649	8

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention - Fall Prevention Standard of Care	235	2,802
Total, all-cause mortality	Control	220	2,649
Total, other adverse events	Intervention - Fall Prevention Standard of Care	0	0
Total, other adverse events	Control	0	0
Total, serious adverse events	Intervention - Fall Prevention Standard of Care	1,139	2,802
Total, serious adverse events	Control	1,108	2,649

Source ClinicalTrials.gov

Papers10

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30020415	DERIVED	PubMed
31245263	DERIVED	PubMed
32212395	DERIVED	PubMed
32408769	DERIVED	PubMed
32640131	DERIVED	PubMed
33037632	DERIVED	PubMed
33678038	DERIVED	PubMed
35932279	DERIVED	PubMed
37533073	DERIVED	PubMed
38740298	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AG048270	Randomized Trial of a Multifactorial Fall Injury Prevention Strategy	BHASIN, SHALENDER; GILL, THOMAS MICHAEL; REUBEN, DAVID B.	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL INSTITUTE ON AGING	2014 to 2019

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention - Fall Prevention Standard of Care vs Control: deaths from any cause	Trial comparisons
Intervention - Fall Prevention Standard of Care vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02475850

GET https://conductscience.org/api/trials/v1/NCT02475850/events?page=2

API reference For AI assistants