Trial Outcomes & Findings for Develop and Validation of Measurement-Based Transition Assistance (NCT NCT05384171)

NCT ID: NCT05384171

Last Updated: 2024-10-09

Results Overview

Participation in the study will be evaluated to assess feasibility of the study procedures. To determine feasibility, at the end of data collection the investigators will calculate the following: 1. Percentage of veterans who enroll in the study out of those invited (baseline; T1) 2. Percentage of veterans who complete both T1 and T2 surveys (baseline \[T1\] and three-month follow-up \[T2\] data) 3. Percentage of veterans who access the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 4. Percentage of veterans who complete the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 5. Percentage of veterans who review the personalized well-being report (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

baseline (T1) and three-month follow-up (T2)

Results posted on

2024-10-09

Participant Flow

Potential participants were recruited through invitations via mail between November 2022 and December 2022. 500 invitations were mailed (25 were undeliverable). Forty-six veterans accessed the study website URL and consented to participate.

Potential participants were randomly assigned to a group prior to mailing (250 to Intervention Group arm and 250 to Active Control Group arm)

Participant milestones

Participant milestones
Measure
Intervention Group
MBTA, MBTA satisfaction measures, and other assessment measures at T1; MBTA and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Overall Study
STARTED
27
19
Overall Study
COMPLETED
15
10
Overall Study
NOT COMPLETED
12
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Group
MBTA, MBTA satisfaction measures, and other assessment measures at T1; MBTA and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Overall Study
Lost to Follow-up
9
9
Overall Study
Withdrawal by Subject
3
0

Baseline Characteristics

Not all participants provided data related to their age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Group
n=24 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1; MBTA and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=19 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Total
n=43 Participants
Total of all reporting groups
Age, Continuous
41.71 years
STANDARD_DEVIATION 11.12 • n=17 Participants • Not all participants provided data related to their age
35.16 years
STANDARD_DEVIATION 8.73 • n=19 Participants • Not all participants provided data related to their age
38.25 years
STANDARD_DEVIATION 10.33 • n=36 Participants • Not all participants provided data related to their age
Sex/Gender, Customized
Male
15 Participants
n=21 Participants • Not all participants provided data related to their gender
13 Participants
n=19 Participants • Not all participants provided data related to their gender
28 Participants
n=40 Participants • Not all participants provided data related to their gender
Sex/Gender, Customized
Female
5 Participants
n=21 Participants • Not all participants provided data related to their gender
6 Participants
n=19 Participants • Not all participants provided data related to their gender
11 Participants
n=40 Participants • Not all participants provided data related to their gender
Sex/Gender, Customized
Other or prefer not to say
1 Participants
n=21 Participants • Not all participants provided data related to their gender
0 Participants
n=19 Participants • Not all participants provided data related to their gender
1 Participants
n=40 Participants • Not all participants provided data related to their gender
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=24 Participants
5 Participants
n=19 Participants
8 Participants
n=43 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=24 Participants
14 Participants
n=19 Participants
34 Participants
n=43 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=24 Participants
0 Participants
n=19 Participants
1 Participants
n=43 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=24 Participants
2 Participants
n=19 Participants
2 Participants
n=43 Participants
Race (NIH/OMB)
Asian
1 Participants
n=24 Participants
0 Participants
n=19 Participants
1 Participants
n=43 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=24 Participants
0 Participants
n=19 Participants
1 Participants
n=43 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=24 Participants
4 Participants
n=19 Participants
9 Participants
n=43 Participants
Race (NIH/OMB)
White
17 Participants
n=24 Participants
12 Participants
n=19 Participants
29 Participants
n=43 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=24 Participants
0 Participants
n=19 Participants
0 Participants
n=43 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=24 Participants
1 Participants
n=19 Participants
1 Participants
n=43 Participants
Region of Enrollment
United States
24 Participants
n=24 Participants
19 Participants
n=19 Participants
43 Participants
n=43 Participants

PRIMARY outcome

Timeframe: baseline (T1) and three-month follow-up (T2)

Population: 500 letters mailed; number analyzed varies per row because of number of eligible participants within each category/row

Participation in the study will be evaluated to assess feasibility of the study procedures. To determine feasibility, at the end of data collection the investigators will calculate the following: 1. Percentage of veterans who enroll in the study out of those invited (baseline; T1) 2. Percentage of veterans who complete both T1 and T2 surveys (baseline \[T1\] and three-month follow-up \[T2\] data) 3. Percentage of veterans who access the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 4. Percentage of veterans who complete the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 5. Percentage of veterans who review the personalized well-being report (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group)

Outcome measures

Outcome measures
Measure
Intervention Group
n=250 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=250 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Number of Participants Assessed for the Feasibility of Study Procedures
Percent of veterans who enroll in the study out of those invited (T1; baseline)
27 Participants
19 Participants
Number of Participants Assessed for the Feasibility of Study Procedures
Percent of veterans who complete both baseline and three-month follow-up surveys (T1 and T2 data)
15 Participants
10 Participants
Number of Participants Assessed for the Feasibility of Study Procedures
Percent who access MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)
22 Participants
10 Participants
Number of Participants Assessed for the Feasibility of Study Procedures
Percent who complete MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)
21 Participants
10 Participants
Number of Participants Assessed for the Feasibility of Study Procedures
Percent who review the personal report (Intervention:baseline; Active Control:three-month follow-up)
21 Participants
10 Participants

PRIMARY outcome

Timeframe: baseline assessment (T1 only for intervention group)

Population: 16 Veterans in the intervention group provided data for open-ended questions at T1 (baseline). T1 (baseline) was the only timeframe when these questions were administered for this group.

For the intervention group at the baseline assessment (T1), the investigators assessed satisfaction with the MBTA tool with items developed specifically for this pilot study. T1 (baseline) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Outcome measures

Outcome measures
Measure
Intervention Group
n=16 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Satisfaction With MBTA Tool
Provided positive feedback about MBTA prototype
14 Participants
Satisfaction With MBTA Tool
Provided a critique about MBTA prototype
5 Participants
Satisfaction With MBTA Tool
Provided constructive feedback about MBTA prototype
4 Participants

PRIMARY outcome

Timeframe: three-month follow-up (T2 only for active control group)

Population: 7 Veterans in the active control group provided data for open-ended questions at T2 (three-month follow-up). T2 (three-month follow-up) was the only timeframe when these questions were administered for this group

For the active control group, they were asked at the three-month follow-up (T2) their satisfaction with the MBTA tool with items developed specifically for this pilot study. T2 (three-month follow-up) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Outcome measures

Outcome measures
Measure
Intervention Group
n=7 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Satisfaction With MBTA Tool
Provided positive feedback about MBTA prototype
7 Participants
Satisfaction With MBTA Tool
Provided a critique about MBTA prototype
3 Participants
Satisfaction With MBTA Tool
Provided constructive feedback about MBTA prototype
2 Participants

SECONDARY outcome

Timeframe: measured at T1(baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: An overall readiness to change score was calculated at T1 (baseline) and T2 (three-month follow-up). Using ANCOVAs, data values represent three-month follow-up adjusted mean scores after controlling for baseline scores and age.

The investigators administered the University of Rhode Island Change Assessment Scale (URICA; DiClemente et al., 2004) to measure movement in the stages of change. Questions in the URICA were slightly modified to focus on well-being. To score the URICA, the investigators will calculate a readiness to change score based on the four stages of change (precontemplation, contemplation, action, and maintenance). The investigators will calculate means for precontemplation responses, contemplation responses, action responses and maintenance responses and subtract the mean from the precontemplation score from the summation of the other three stages. This sum score represents an individual's readiness to change. Possible readiness to change scores range from -2 to +14, with higher scores indicating higher levels of readiness to change.

Outcome measures

Outcome measures
Measure
Intervention Group
n=8 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=9 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
University of Rhode Island Change Assessment Scale (URICA) - Readiness to Change
11.20 score on a scale
Standard Error 0.72
10.69 score on a scale
Standard Error 0.68

SECONDARY outcome

Timeframe: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; challenges reported are from baseline (T1) and if they were were taking action to address these challenges are data from three-month follow-up

Population: Data were collected for intervention and active control group at baseline and three-month follow-up. Among participants who identified a challenge within a domain. Then within that subgroup of those with challenges, we examined the number that moved forward at least one stage/were taking action to work on their challenges between baseline (T1) and the three-month follow-up (T2).

The investigators administered the Stages Algorithm (DiClemente et al., 1991) to measure movement in the stages of change from baseline to the three-month follow-up. Questions were modified slightly to assess for willingness to work on resolving problems or challenges related to areas of well-being (i.e., mental health/emotional well-being, physical health, vocation, social life, and finances). This measure is designed as a decision tree based on reported challenges, and is scored based on where participants fall within the decision tree. It classifies participants according to the following stages of change: precontemplation, contemplation, preparation, action, and maintenance stages.

Outcome measures

Outcome measures
Measure
Intervention Group
n=15 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=10 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Stages Algorithm
Vocation (reported challenges at T1; baseline)
7 Participants
5 Participants
Stages Algorithm
Vocation(of those reporting challenges at T1, # that were taking action to work on challenges at T2)
7 Participants
5 Participants
Stages Algorithm
Finances (reported challenges at T1; baseline)
5 Participants
3 Participants
Stages Algorithm
Finances(of those reporting challenges at T1, # that were taking action to work on challenges at T2)
5 Participants
2 Participants
Stages Algorithm
Social (reported challenges at T1; baseline)
11 Participants
5 Participants
Stages Algorithm
Social (of those reporting challenges at T1, # that were taking action to work on challenges at T2)
10 Participants
4 Participants
Stages Algorithm
Mental Health (reported challenges at T1; baseline)
9 Participants
7 Participants
Stages Algorithm
Mental Health(of those with challenges at T1, # that were taking action to work on challenges at T2)
7 Participants
6 Participants
Stages Algorithm
Physical Health (reported challenges at T1; baseline)
13 Participants
7 Participants
Stages Algorithm
Physical Health(of those with T1 challenges, # that were taking action to work on challenges at T2)
10 Participants
7 Participants

SECONDARY outcome

Timeframe: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: Scores were calculated at T1 (baseline) and T2 (three-month follow-up) for intervention and active control group. Scores could range from 1 to 7 with higher scores indicating a more positive response. Number of participants analyzed for each row varies based on the number of participants that provided data for that construct at both time points. Using ANCOVAs, data values represent three-month follow-up adjusted mean (follow-up) scores after controlling for baseline scores and age.

The investigators used Theory of Planned Behavior Questionnaire (Ajzen, 1991) to assess movement from baseline to the three-month follow-up in the constructs from the theory of planned behavior (intention, attitude toward the behavior, subjective norm, perceived behavioral control). Questions were slightly modified to focus on well-being. The investigators scored each of the aforementioned constructs/subscales separately. For each subscale, the investigators calculated the the mean of the items. Scores could range from 1 to 7 with higher scores indicating a more positive response.

Outcome measures

Outcome measures
Measure
Intervention Group
n=11 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=10 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Theory of Planned Behavior Constructs
Intentions
4.95 score on a scale
Standard Error 0.35
5.61 score on a scale
Standard Error 0.36
Theory of Planned Behavior Constructs
Attitudes
5.97 score on a scale
Standard Error 0.31
6.03 score on a scale
Standard Error 0.31
Theory of Planned Behavior Constructs
Social norms
5.14 score on a scale
Standard Error 0.33
4.68 score on a scale
Standard Error 0.36
Theory of Planned Behavior Constructs
Perceived behavioral control
5.53 score on a scale
Standard Error 0.32
5.05 score on a scale
Standard Error 0.34

SECONDARY outcome

Timeframe: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: Possible scores ranged from 0 to 30, with higher scores indicating more positive attitudes toward seeking professional help. Using ANCOVAs, data values represent three-month follow-up adjusted mean (follow-up) scores after controlling for baseline scores and age

The investigators assessed movement in support seeking perceptions from baseline (T1) to the three-month follow-up (T2) with the Attitudes Toward Seeking Professional Psychological Help - Short Form scale (Picco et al., 2016). Questions were slightly modified to focus on seeking support to address well-being challenges and problems. To calculate a total score, items 2, 4, 8, 9, and 10 were reverse scored. Scores were then summed together, with higher scores indicating more positive attitudes toward seeking professional help. Scores could range range for 0-30.

Outcome measures

Outcome measures
Measure
Intervention Group
n=11 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
n=10 Participants
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Attitudes Toward Seeking Professional Psychological Help-Short Form
19.24 score on a scale
Standard Error 0.95
19.04 score on a scale
Standard Error 1.00

SECONDARY outcome

Timeframe: Measured at T2 (three-month follow-up) for intervention group only

Population: 15 veterans in the intervention group provided data for support-seeking actions at T2 (three-month follow-up); number of participants analyzed is different because type of service percentage applies only to those that used services (n=10). These measures were only administered to the intervention group at T2 (three-month follow-up). These measures were not administered to the active control group at either time point.

For the intervention group, the investigators assessed support seeking behavior with items developed specifically for this pilot study at T2 (three-month follow-up). Questions asked about the extent to which the tool has helped increase awareness about well-being related challenges or problems, the extent to which the tool has helped encourage improving well-being related problems or challenges, and which types of resources the participant has used since using the tool. Items were examined separately. A response of moderately or higher on the two Likert scale items was considered a positive response.

Outcome measures

Outcome measures
Measure
Intervention Group
n=15 Participants
MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three-month follow-up) Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
Support-Seeking Actions to Improve Well-Being
Reported MBTA prototype increased awareness about their well-being related challenges or problems
6 Participants
Support-Seeking Actions to Improve Well-Being
Reported MBTA prototype helped encourage them to improve well-being related problems or challenges
7 Participants
Support-Seeking Actions to Improve Well-Being
Reported using a resource/service (not previously using before study) as a result the MBTA prototype
10 Participants
Support-Seeking Actions to Improve Well-Being
Used a mental health resource/service
5 Participants
Support-Seeking Actions to Improve Well-Being
Used a financial resource/service
2 Participants
Support-Seeking Actions to Improve Well-Being
Used a health behavior resource/service
1 Participants
Support-Seeking Actions to Improve Well-Being
Used other general health resource/service
1 Participants
Support-Seeking Actions to Improve Well-Being
Used a resource/service related to their social life
1 Participants
Support-Seeking Actions to Improve Well-Being
Used a resource/service under an 'other' category
3 Participants
Support-Seeking Actions to Improve Well-Being
Used a vocation-related resource/service
0 Participants

Adverse Events

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Control Group

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

Dr. Dawne Vogt

VA Boston Healthcare system

Phone: 857-364-5976

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place