Trial Outcomes & Findings for Me & My Wishes: An Efficacy Trial Using Videos (NCT NCT03861429)
NCT ID: NCT03861429
Last Updated: 2024-06-26
Results Overview
At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point. Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions. Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
Baseline, time of sharing (3 months from baseline), and 90 days post sharing video
Results posted on
2024-06-26
Participant Flow
Unit of analysis: nursing homes, assisted living
Participant milestones
| Measure |
Me & My Wishes Intervention/Group 1
In Group 1 (early intervention group) NHs, families, and staff video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2
In Group 2 (delayed sharing) NHs, residents, families, and staff will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Overall Study
STARTED
|
64 4
|
74 4
|
|
Overall Study
Residents
|
17 4
|
19 4
|
|
Overall Study
Family
|
25 4
|
25 4
|
|
Overall Study
Staff
|
13 4
|
25 4
|
|
Overall Study
COMPLETED
|
55 4
|
69 4
|
|
Overall Study
NOT COMPLETED
|
9 0
|
5 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age not reported for two participants (e.g., left blank)
Baseline characteristics by cohort
| Measure |
Me & My Wishes Intervention/Group 1 Residents
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Residents
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Intervention/Group 1 Family
n=25 Participants
In Group 1 (early intervention group) NHs, resident's video will be shared within three months of baseline.
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared.
|
Me & My Wishes Wait-list Control/Group 2 Family
n=25 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be shared with family within three months.
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared.
|
Me & My Wishes Intervention/Group 1 Staff
n=13 Participants
In Group 1 (early intervention group) NHs, resident's video will be shared with staff within three months of baseline.
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared.
|
Me & My Wishes Wait-list Control/Group 2 Staff
n=25 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be shared with staff within three months.
Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Videos are then shared.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=19 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=12 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=24 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=122 Participants • Age not reported for two participants (e.g., left blank)
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=17 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=19 Participants • Age not reported for two participants (e.g., left blank)
|
17 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
13 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
12 Participants
n=12 Participants • Age not reported for two participants (e.g., left blank)
|
21 Participants
n=24 Participants • Age not reported for two participants (e.g., left blank)
|
63 Participants
n=122 Participants • Age not reported for two participants (e.g., left blank)
|
|
Age, Categorical
>=65 years
|
17 Participants
n=17 Participants • Age not reported for two participants (e.g., left blank)
|
19 Participants
n=19 Participants • Age not reported for two participants (e.g., left blank)
|
8 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
12 Participants
n=25 Participants • Age not reported for two participants (e.g., left blank)
|
0 Participants
n=12 Participants • Age not reported for two participants (e.g., left blank)
|
3 Participants
n=24 Participants • Age not reported for two participants (e.g., left blank)
|
59 Participants
n=122 Participants • Age not reported for two participants (e.g., left blank)
|
|
Age, Continuous
|
64.77 years
STANDARD_DEVIATION 17.31 • n=17 Participants
|
57.75 years
STANDARD_DEVIATION 18.24 • n=19 Participants
|
59.84 years
STANDARD_DEVIATION 10.15 • n=25 Participants
|
61.56 years
STANDARD_DEVIATION 12.88 • n=25 Participants
|
47.33 years
STANDARD_DEVIATION 10.97 • n=13 Participants
|
41.58 years
STANDARD_DEVIATION 16.83 • n=25 Participants
|
60.86 years
STANDARD_DEVIATION 18.11 • n=124 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=17 Participants
|
13 Participants
n=19 Participants
|
15 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
12 Participants
n=13 Participants
|
20 Participants
n=25 Participants
|
90 Participants
n=124 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=17 Participants
|
6 Participants
n=19 Participants
|
10 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
1 Participants
n=13 Participants
|
5 Participants
n=25 Participants
|
34 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=17 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
5 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=17 Participants
|
17 Participants
n=19 Participants
|
24 Participants
n=25 Participants
|
24 Participants
n=25 Participants
|
13 Participants
n=13 Participants
|
23 Participants
n=25 Participants
|
117 Participants
n=124 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=124 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=17 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
6 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=25 Participants
|
2 Participants
n=124 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=17 Participants
|
18 Participants
n=19 Participants
|
25 Participants
n=25 Participants
|
24 Participants
n=25 Participants
|
13 Participants
n=13 Participants
|
19 Participants
n=25 Participants
|
113 Participants
n=124 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=124 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=124 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=17 Participants
|
19 Participants
n=19 Participants
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
13 Participants
n=13 Participants
|
25 Participants
n=25 Participants
|
124 Participants
n=124 Participants
|
PRIMARY outcome
Timeframe: Baseline, time of sharing (3 months from baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities
At each specified time point, a chart review was conducted to obtain whether goals of care discussions occurred (change in documentation in medical record, e.g. social work note), yes/no. Reported values indicated residents who had a documented GOC in chart (yes) at any time point. Goal of Care Conversations encompass two parts. A) some sharing of disease status / prognosis + B) discussion of a choice of goals/treatment decisions. Examples of Part A include disease understanding, disease state, disease progression, prognosis/life expectancy, documentation that the clinician tried to discuss prognosis but the patient/family refused
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Number of Participants With a Documented Discussion of Goals of Care
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, time of sharing (3 months from baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
Confidence in expressing or communicating about resident preferences. Self-efficacy items, range 1-5, higher is more confident.
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Self-efficacy for Communicating Preferences
Baseline
|
4.26 score on a scale
Standard Error .13
|
4.26 score on a scale
Standard Error .13
|
|
Self-efficacy for Communicating Preferences
Time of sharing
|
4.37 score on a scale
Standard Error .15
|
3.77 score on a scale
Standard Error .26
|
|
Self-efficacy for Communicating Preferences
90 day
|
4.38 score on a scale
Standard Error .16
|
3.96 score on a scale
Standard Error .25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched.
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Concordance of Psychosocial Preferences Between Video and Staff
Baseline
|
47.87 percentage of agreement
Standard Deviation 29.87
|
44.87 percentage of agreement
Standard Deviation 31.82
|
|
Concordance of Psychosocial Preferences Between Video and Staff
Time of Sharing
|
77.50 percentage of agreement
Standard Deviation 19.45
|
87.25 percentage of agreement
Standard Deviation 18.28
|
|
Concordance of Psychosocial Preferences Between Video and Staff
90 days
|
68.60 percentage of agreement
Standard Deviation 24.45
|
60.29 percentage of agreement
Standard Deviation 30.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and staff member response matched.
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Concordance of End of Life Preferences, Video and Staff
Baseline
|
29.79 percentage of agreement
Standard Deviation 24.98
|
27.18 percentage of agreement
Standard Deviation 25.37
|
|
Concordance of End of Life Preferences, Video and Staff
Time of Sharing
|
63.50 percentage of agreement
Standard Deviation 22.59
|
55.29 percentage of agreement
Standard Deviation 28.17
|
|
Concordance of End of Life Preferences, Video and Staff
90 days
|
60.93 percentage of agreement
Standard Deviation 23.07
|
46.27 percentage of agreement
Standard Deviation 28.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
Psychosocial preferences include having family at the bedside; engaging in faith practices, such as prayer; having a pet at bedside; and engaging in activities such as being read to or listening to music. Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched.
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Concordance of Psychosocial Preferences, Video and Family
Baseline
|
67.31 percentage of agreement
Standard Deviation 24.26
|
64.13 percentage of agreement
Standard Deviation 30.92
|
|
Concordance of Psychosocial Preferences, Video and Family
Time of Sharing
|
72.00 percentage of agreement
Standard Deviation 22.03
|
83.70 percentage of agreement
Standard Deviation 23.37
|
|
Concordance of Psychosocial Preferences, Video and Family
90 days
|
71.74 percentage of agreement
Standard Deviation 24.20
|
85.53 percentage of agreement
Standard Deviation 19.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, time of sharing (within 3 months of baseline), and 90 days post sharing videoPopulation: persons living with dementia (PLWD) in long-term care (LTC) settings, such as nursing homes and assisted living communities.
EOL preferences include treatment preferences (cardiopulmonary resuscitation, or CPR; breathing machine; tube feeding; life support; and pain treatment). Preferences from the videos and surveys were coded as yes, no, don't know, or missing. Concordance occurred when the coded preferences in the resident's video and family member response matched.
Outcome measures
| Measure |
Me & My WishesIntervention/Group 1 Resident
n=17 Participants
In Group 1 (early intervention group) NHs, video recording, editing, and viewing will occur within three months of baseline.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
Me & My Wishes Wait-list Control/Group 2 Resident
n=19 Participants
In Group 2 (delayed sharing) NHs, residents will be on a wait-list; after the delayed start, their video will be produced and viewed within three months.
Me \& My Wishes: Me \& My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me \& My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
|
|---|---|---|
|
Concordance of End of Life Preferences, Video and Family
Baseline
|
48.15 percentage of agreement
Standard Deviation 23.04
|
38.26 percentage of agreement
Standard Deviation 35.63
|
|
Concordance of End of Life Preferences, Video and Family
Time of Sharing
|
60.80 percentage of agreement
Standard Deviation 23.44
|
62.61 percentage of agreement
Standard Deviation 26.49
|
|
Concordance of End of Life Preferences, Video and Family
90 days
|
53.91 percentage of agreement
Standard Deviation 17.51
|
52.63 percentage of agreement
Standard Deviation 24.23
|
Adverse Events
Me & My Wishes Intervention/Group 1 Resident
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Me & My Wishes Wait-list Control/Group 2 Resident
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Me & My Wishes Intervention/Group 1 Family
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Me & My Wishes Wait-list Family
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Me & My Wishes Intervention Group 1 Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Me & My Wishes Control/Group 2 Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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