Trial Outcomes & Findings for Communication Bridge 2 (NCT NCT03371706)
NCT ID: NCT03371706
Last Updated: 2024-10-17
Results Overview
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 months
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Communication Bridge™ (Persons With Primary Progressive Aphasia)
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Communication Bridge™ (Care Partners
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Persons With Primary Progressive Aphasia)
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Care Partners)
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
39
|
39
|
|
Overall Study
COMPLETED
|
50
|
50
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Communication Bridge 2
Baseline characteristics by cohort
| Measure |
Communication Bridge™ (Persons With Primary Progressive Aphasia)
n=56 Participants
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Persons With Primary Progressive Aphasia)
n=39 Participants
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age at baseline
|
66.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Years of education
|
16.2 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
16.4 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsPopulation: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.
Communication Confidence Rating Scale in Aphasia, a 0-100 numeric rating scale with 0 representing 'not confident' and 100 representing 'very confident'. Higher scores indicate greater confidence.
Outcome measures
| Measure |
Communication Bridge™ (Person With Primary Progressive Aphasia)
n=56 Participants
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)
n=39 Participants
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Change in Communication Confidence (CCRSA)
Baseline
|
72.6 units on a scale
Standard Error 1.8
|
72.9 units on a scale
Standard Error 2.6
|
|
Change in Communication Confidence (CCRSA)
Post Intervention 1 (3 months)
|
73.7 units on a scale
Standard Error 1.9
|
74.5 units on a scale
Standard Error 2.4
|
|
Change in Communication Confidence (CCRSA)
Six Months
|
72.1 units on a scale
Standard Error 2.1
|
73.1 units on a scale
Standard Error 2.5
|
|
Change in Communication Confidence (CCRSA)
Post Intervention 2 (9 months)
|
72.2 units on a scale
Standard Error 2.2
|
71.6 units on a scale
Standard Error 2.5
|
|
Change in Communication Confidence (CCRSA)
12 Months
|
69.1 units on a scale
Standard Error 2.7
|
70.1 units on a scale
Standard Error 2.5
|
PRIMARY outcome
Timeframe: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsPopulation: the number analyzed in some rows differs from the overall number analyzed due to participant withdrawal and missing data.
Communication Participation Item Bank is a 4-point rating scale with 0 representing 'very much' and 3 representing 'not at all'. Higher scores indicate greater severity of communication challenges. We are reporting on change in CPIB scores using T-scores. The Communicative Participation Item Bank (CPIB) T-score range is as follows: T57.5 and above: Represents a "normal" experience of communicative participation or "minimal problems" T57.5-T45: Represents mild challenges T45-T35: Represents moderate challenges T35 and below: Represents severe challenges The CPIB is a patient-reported instrument that measures communicative participation. The mean T-score is 50, and the standard deviation is 10. Higher scores are more favorable, indicating less interference in participation. The ideal score, or someone who reports no problems with communicative participation, would be a T-score of 74.3
Outcome measures
| Measure |
Communication Bridge™ (Person With Primary Progressive Aphasia)
n=56 Participants
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)
n=39 Participants
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Change in Communication Participation Item Bank (CPIB)
Baseline
|
46.0 units on a scale
Standard Error 0.8
|
47.1 units on a scale
Standard Error 1.0
|
|
Change in Communication Participation Item Bank (CPIB)
Post Intervention 1 (3 months)
|
47.4 units on a scale
Standard Error 0.9
|
47.7 units on a scale
Standard Error 1.9
|
|
Change in Communication Participation Item Bank (CPIB)
Six Months
|
45.6 units on a scale
Standard Error 1.0
|
46.8 units on a scale
Standard Error 1.1
|
|
Change in Communication Participation Item Bank (CPIB)
Post Intervention 2 (9 months)
|
46.0 units on a scale
Standard Error 0.9
|
46.3 units on a scale
Standard Error 1.0
|
|
Change in Communication Participation Item Bank (CPIB)
12 Months
|
45.5 units on a scale
Standard Error 1.0
|
45.0 units on a scale
Standard Error 1.0
|
PRIMARY outcome
Timeframe: 4 assessment time points through study completion - Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsThis measure assesses progress toward communication participation goals using Goal Attainment Scaling (GAS). Participants developed personalized goals, each set to a baseline value of '0'. Progress was tracked using a 7-point scale, where -3 represents 'no longer participating' and +3 represents 'exceeded goal'. Higher scores indicate better progress toward goal achievement. Goals were evaluated at 3, 6, 9, and 12 months, with the results reported as the percentage of goals that: Worsened (scores of -1, -2, or -3) No change (score remained at 0) Improved (scores of +1, +2, or +3), including getting close to, reaching, or exceeding the goal. The table below presents the percentage of goals falling into each of these categories at each assessment point.
Outcome measures
| Measure |
Communication Bridge™ (Person With Primary Progressive Aphasia)
n=159 Number of Goals
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)
n=116 Number of Goals
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Change in Communication Participation Person Centered Goals
Post Intervention 1 - (Worse than baseline)
|
3.8 percentage of goals
|
6.9 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Post Intervention 1 - (No change from baseline)
|
29.6 percentage of goals
|
44.0 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Post Intervention 1 - (Getting close to, reached, or exceed) goal
|
66.7 percentage of goals
|
49.1 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Six Months - (Worse than baseline)
|
16.3 percentage of goals
|
18.0 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Six Months - (No change from baseline)
|
23.5 percentage of goals
|
35.0 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Six Months - (Getting close to , reached, or exceeded expected goal)
|
60.1 percentage of goals
|
47.0 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Post Intervention 2 - (Worse than baseline)
|
16.0 percentage of goals
|
18.8 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Post Intervention 2 - (No change from baseline)
|
22.0 percentage of goals
|
26.5 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
Post Intervention 2 - (Getting close to, reached or exceeded expected goal)
|
62.0 percentage of goals
|
54.7 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
12 Months (Worse than baseline)
|
21.3 percentage of goals
|
20.2 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
12 Months - (No change from baseline)
|
18.0 percentage of goals
|
23.7 percentage of goals
|
|
Change in Communication Participation Person Centered Goals
12 Months - (Getting close to, reached or exceeded expected goal)
|
60.7 percentage of goals
|
56.1 percentage of goals
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsproportion of participants accuracy on trained words. Higher values indicate greater number of words produced after first prompt. Range 0 - 30
Outcome measures
| Measure |
Communication Bridge™ (Person With Primary Progressive Aphasia)
n=56 Participants
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)
n=39 Participants
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Change in Word Accuracy (Trained Words)
Baseline
|
18.2 words
Standard Error 1.0
|
13.6 words
Standard Error 1.1
|
|
Change in Word Accuracy (Trained Words)
Post Intervention 1 (PIE1) (3 months)
|
25.2 words
Standard Error 0.8
|
25.1 words
Standard Error 1.0
|
|
Change in Word Accuracy (Trained Words)
Six Months
|
23.6 words
Standard Error 1.0
|
23.5 words
Standard Error 1.0
|
|
Change in Word Accuracy (Trained Words)
Post Intervention 2 (PIE2) (9 months)
|
25.1 words
Standard Error 0.9
|
23.7 words
Standard Error 1.1
|
|
Change in Word Accuracy (Trained Words)
12 months
|
22.7 words
Standard Error 1.1
|
21.8 words
Standard Error 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 assessment time points through study completion - Baseline, Post Intervention 1 (3 months), Six months, Post Intervention 2 (9 months), and 12 monthsproportion of participants accuracy on trained scripts. Higher values indicate greater level of script performance as a proportion. Range 0 - 1.
Outcome measures
| Measure |
Communication Bridge™ (Person With Primary Progressive Aphasia)
n=56 Participants
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused (Person With Primary Progressive Aphasia)
n=39 Participants
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Change in Script Accuracy (Trained Scripts)
Post Intervention 2 (PIE2) (9 months)
|
0.66 proportion of accuracy
Standard Error 0.04
|
0.70 proportion of accuracy
Standard Error 0.05
|
|
Change in Script Accuracy (Trained Scripts)
Baseline
|
0.23 proportion of accuracy
Standard Error 0.03
|
0.27 proportion of accuracy
Standard Error 0.03
|
|
Change in Script Accuracy (Trained Scripts)
Post Intervention 1 (PIE1) (3 months)
|
0.59 proportion of accuracy
Standard Error 0.05
|
0.64 proportion of accuracy
Standard Error 0.06
|
|
Change in Script Accuracy (Trained Scripts)
Six Months
|
0.60 proportion of accuracy
Standard Error 0.05
|
0.62 proportion of accuracy
Standard Error 0.06
|
|
Change in Script Accuracy (Trained Scripts)
12 Months
|
0.60 proportion of accuracy
Standard Error 0.05
|
0.55 proportion of accuracy
Standard Error 0.06
|
Adverse Events
Communication Bridge™
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Evidence-Based Impairment Focused
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Communication Bridge™
n=56 participants at risk
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused
n=39 participants at risk
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Surgical and medical procedures
Medical event
|
10.7%
6/56 • Number of events 6 • 1 year
|
10.3%
4/39 • Number of events 6 • 1 year
|
|
Social circumstances
Psychosocial events
|
1.8%
1/56 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
Other adverse events
| Measure |
Communication Bridge™
n=56 participants at risk
Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.
Communication Bridge™: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
Evidence-Based Impairment Focused
n=39 participants at risk
The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.
Evidence-Based Impairment Focused: Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
|
|---|---|---|
|
Social circumstances
Frustration/Fatigue due to cognitive testing
|
1.8%
1/56 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Social circumstances
Frustration/Fatigue due to therapy sessions
|
1.8%
1/56 • Number of events 1 • 1 year
|
0.00%
0/39 • 1 year
|
|
Social circumstances
Psychosocial events
|
5.4%
3/56 • Number of events 3 • 1 year
|
17.9%
7/39 • Number of events 10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place