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Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475850
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborators:
Yale University
University of California, Los Angeles
Healthcare Partners
The University of Texas Medical Branch, Galveston
University of Pittsburgh Medical Center
Johns Hopkins University
Mt Sinai Health System
Reliant Medical Group
Partners HealthCare
University of Michigan
University of Iowa Health Alliance
Essentia Health
Wake Forest University
National Institute on Aging (NIA)
Patient-Centered Outcomes Research Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy Latham, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Accidental Falls
Wounds and Injuries
Interventions Other: Evidence-based tailored fall prevention
Other: Usual care
Enrollment 5451
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Period Title: Overall Study
Started 2802 2649
Completed 2209 2165
Not Completed 593 484
Reason Not Completed
Death             155             141
Lost to Follow-up             217             188
Withdrawal by Subject             221             155
Arm/Group Title Control Intervention Total
Hide Arm/Group Description

Usual fall prevention care

Usual care

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Total of all reporting groups
Overall Number of Baseline Participants 2649 2802 5451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2649 participants 2802 participants 5451 participants
79.5  (5.8) 79.9  (5.7) 79.7  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
Female
1629
  61.5%
1752
  62.5%
3381
  62.0%
Male
1020
  38.5%
1050
  37.5%
2070
  38.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
Hispanic or Latino
211
   8.0%
196
   7.0%
407
   7.5%
Not Hispanic or Latino
2428
  91.7%
2592
  92.5%
5020
  92.1%
Unknown or Not Reported
10
   0.4%
14
   0.5%
24
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
American Indian or Alaska Native
4
   0.2%
4
   0.1%
8
   0.1%
Asian
26
   1.0%
44
   1.6%
70
   1.3%
Native Hawaiian or Other Pacific Islander
1
   0.0%
5
   0.2%
6
   0.1%
Black or African American
164
   6.2%
128
   4.6%
292
   5.4%
White
2394
  90.4%
2571
  91.8%
4965
  91.1%
More than one race
22
   0.8%
16
   0.6%
38
   0.7%
Unknown or Not Reported
38
   1.4%
34
   1.2%
72
   1.3%
Positive on Fall Risk Screening Questions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
Fallen 2 or more times in past year
896
  33.8%
1015
  36.2%
1911
  35.1%
Fallen and hurt yourself in past year
1031
  38.9%
1089
  38.9%
2120
  38.9%
Fear of falling because of balance or walking problems
2274
  85.8%
2405
  85.8%
4679
  85.8%
Educational Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
High school graduate or less
643
  24.3%
602
  21.5%
1245
  22.8%
Some college or equivalent
659
  24.9%
697
  24.9%
1356
  24.9%
College graduate or higher
1343
  50.7%
1502
  53.6%
2845
  52.2%
Unknown
4
   0.2%
1
   0.0%
5
   0.1%
Chronic coexisting conditions - number per participant  
Mean (Standard Deviation)
Unit of measure:  Number chronic conditions per subject
Number Analyzed 2649 participants 2802 participants 5451 participants
2.1  (1.3) 2.1  (1.3) 2.1  (1.3)
Clinically significant cognitive impairment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
75
   2.8%
85
   3.0%
160
   2.9%
[1]
Measure Description: Four or more errors on 6-item Callahan cognitive screener OR the interview was completed entirely by proxy
Use of mobility aid or inability to ambulate  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
909
  34.3%
972
  34.7%
1881
  34.5%
Number of positive responses to screening questions regarding fall injuries  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
1
1571
  59.3%
1634
  58.3%
3205
  58.8%
2
605
  22.8%
629
  22.4%
1234
  22.6%
3
473
  17.9%
539
  19.2%
1012
  18.6%
History of fracture other than of the hip after 50 yr of age  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
876
  33.1%
918
  32.8%
1794
  32.9%
History of hip fracture after 50 years of age  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2649 participants 2802 participants 5451 participants
119
   4.5%
132
   4.7%
251
   4.6%
1.Primary Outcome
Title First Adjudicated Serious Fall-Related Injury
Hide Description Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.
Time Frame Enrollment through last completed follow-up or death interview (max 44 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 2802 2649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 100 person years of follow-up
4.87
(4.31 to 5.43)
5.34
(4.55 to 6.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments p<0.05 threshold (primary outcome)
Method Regression, Cox
Comments multistate model accounting for death as a semi-competing risk
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.80 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title First Self-reported Fall-related Injury
Hide Description Number of first self-reported fall-related injuries per 100 per years of follow-up
Time Frame Enrollment through last completed follow-up or death interview (max 44 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 2802 2649
Measure Type: Number
Number (99% Confidence Interval)
Unit of Measure: events per 100 person years of follow-up
25.64
(24.19 to 27.08)
28.62
(26.53 to 30.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments p< 0.01 threshold (secondary outcome)
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.90
Confidence Interval (2-Sided) 99%
0.83 to 0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Self-reported Falls
Hide Description ** data for this outcome was not collected
Time Frame these data were not collected
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Physical Function
Hide Description 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
Time Frame measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Hide Outcome Measure Data
Hide Analysis Population Description
subsample selected for well-being measures with completed baseline LL-FDI
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 380 358
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
58.45  (0.48) 57.73  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.309
Comments p < 0.01 threshold (secondary outcome)
Method Mixed Models Analysis
Comments random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
Method of Estimation Estimation Parameter Difference in least-squared means across
Estimated Value 0.72
Confidence Interval (2-Sided) 99%
-1.10 to 2.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.71
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Disability
Hide Description 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
Time Frame measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Hide Outcome Measure Data
Hide Analysis Population Description
subsample selected for well-being measures with completed baseline LL-FDI
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 380 358
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
55.16  (0.63) 54.57  (0.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments p < 0.01 threshold (secondary outcome)
Method Mixed Models Analysis
Comments random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
Method of Estimation Estimation Parameter Least squares means
Estimated Value 0.59
Confidence Interval (2-Sided) 99%
-1.80 to 0.93
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Anxiety
Hide Description Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.
Time Frame Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Hide Outcome Measure Data
Hide Analysis Population Description
subsample selected for well-being measures and with completed baseline PROMIS Anxiety
Arm/Group Title Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 371 350
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.63  (0.29) 12.53  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments p < 0.01 threshold (secondary outcome)
Method Mixed Models Analysis
Comments random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
Method of Estimation Estimation Parameter Least squares means
Estimated Value -0.90
Confidence Interval (2-Sided) 99%
-2.00 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.43
Estimation Comments Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)
7.Secondary Outcome
Title Depression
Hide Description PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.
Time Frame Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Hide Outcome Measure Data
Hide Analysis Population Description
subsample selected for well-being measures and with completed baseline PROMIS dep
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 372 350
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.75  (0.31) 12.94  (0.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments p<0.01 threshold (secondary outcome)
Method Mixed Models Analysis
Comments random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
Method of Estimation Estimation Parameter Least squares means
Estimated Value -1.19
Confidence Interval (2-Sided) 99%
-2.36 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.45
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Fear of Falling
Hide Description Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.
Time Frame Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Hide Outcome Measure Data
Hide Analysis Population Description
subsample selected for well-being measures and with completed baseline FES
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description:

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

Overall Number of Participants Analyzed 372 351
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
16.03  (0.35) 16.10  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention - Fall Prevention Standard of Care, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments p <0.01 threshold (secondary outcome)
Method Mixed Models Analysis
Comments random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness
Method of Estimation Estimation Parameter Least squares means
Estimated Value -0.07
Confidence Interval (2-Sided) 99%
-1.38 to 1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)
Time Frame Enrollment through death, withdrawal, or end of study (max 44 months)
Adverse Event Reporting Description Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
 
Arm/Group Title Intervention - Fall Prevention Standard of Care Control
Hide Arm/Group Description

An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach

Evidence-based tailored fall prevention

Usual fall prevention care

Usual care

All-Cause Mortality
Intervention - Fall Prevention Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%)
Total   235/2802 (8.39%)      220/2649 (8.31%)    
Hide Serious Adverse Events
Intervention - Fall Prevention Standard of Care Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1139/2802 (40.65%)      1108/2649 (41.83%)    
Blood and lymphatic system disorders     
hospitalization  1  24/2802 (0.86%)  29 29/2649 (1.09%)  34
Cardiac disorders     
hospitalization  1  199/2802 (7.10%)  270 199/2649 (7.51%)  259
Congenital, familial and genetic disorders     
hospitalization  1  1/2802 (0.04%)  1 2/2649 (0.08%)  2
Ear and labyrinth disorders     
hospitalization  1  7/2802 (0.25%)  7 3/2649 (0.11%)  3
Endocrine disorders     
hospitalization  1  7/2802 (0.25%)  7 7/2649 (0.26%)  8
Eye disorders     
hospitalization  1  4/2802 (0.14%)  4 5/2649 (0.19%)  5
Gastrointestinal disorders     
hospitalization  1  161/2802 (5.75%)  208 135/2649 (5.10%)  176
General disorders     
hospitalization  1  159/2802 (5.67%)  194 152/2649 (5.74%)  168
Hepatobiliary disorders     
hospitalization  1  11/2802 (0.39%)  13 17/2649 (0.64%)  19
Immune system disorders     
hospitalization  1  4/2802 (0.14%)  4 1/2649 (0.04%)  1
Infections and infestations     
hospitalization  1  252/2802 (8.99%)  324 231/2649 (8.72%)  298
Injury, poisoning and procedural complications     
hospitalization  1  187/2802 (6.67%)  225 196/2649 (7.40%)  242
Investigations     
hospitalization  1  21/2802 (0.75%)  22 32/2649 (1.21%)  35
Metabolism and nutrition disorders     
hospitalization  1  54/2802 (1.93%)  59 55/2649 (2.08%)  70
Musculoskeletal and connective tissue disorders     
hospitalization  1  173/2802 (6.17%)  205 156/2649 (5.89%)  182
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
hospitalization  1  51/2802 (1.82%)  59 52/2649 (1.96%)  58
Nervous system disorders     
hospitalization  1  178/2802 (6.35%)  230 153/2649 (5.78%)  192
Pregnancy, puerperium and perinatal conditions     
hospitalization  1  0/2802 (0.00%)  0 1/2649 (0.04%)  1
Psychiatric disorders     
hospitalization  1  26/2802 (0.93%)  31 24/2649 (0.91%)  30
Renal and urinary disorders     
hospitalization  1  51/2802 (1.82%)  54 55/2649 (2.08%)  67
Reproductive system and breast disorders     
hospitalization  1  8/2802 (0.29%)  8 6/2649 (0.23%)  6
Respiratory, thoracic and mediastinal disorders     
hospitalization  1  156/2802 (5.57%)  196 119/2649 (4.49%)  156
Skin and subcutaneous tissue disorders     
hospitalization  1  5/2802 (0.18%)  6 6/2649 (0.23%)  6
Social circumstances     
hospitalization  1  5/2802 (0.18%)  6 2/2649 (0.08%)  2
Vascular disorders     
hospitalization  1  101/2802 (3.60%)  116 119/2649 (4.49%)  135
hospitalization  1  63/2802 (2.25%)  72 77/2649 (2.91%)  91
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention - Fall Prevention Standard of Care Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Erich Greene PhD
Organization: Yale University
Phone: 203-737-3636
EMail: erich.greene@yale.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nancy Latham, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02475850    
Other Study ID Numbers: U01AG048270 ( U.S. NIH Grant/Contract )
1U01AG048270-01 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2015
First Posted: June 19, 2015
Results First Submitted: January 13, 2021
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021