CClinicalTrials.gg
CompletedNCT04515771PARTNER-MHUpdated Sep 19, 2024Results posted

Improving Patient-Provider Communication to Reduce Mental Health Disparities

An interventional study of PARTNER-MH in Healthcare Disparities and Mental Health, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to develop and pilot test an intervention to reduce mental health disparities for racially and ethnically minoritized Veterans receiving outpatient VA mental health services. The program was delivered by trained VA peer navigators. The specific aims of the program were to enhance navigation of mental health services, increase patient engagement, and improve patient-provider communication.

Study participants were randomized into one of two study groups, which determined when they received the study intervention. Regardless of study group, participants had the opportunity to receive services in addition to their regular mental health treatment (either immediately after enrollment into the study or after a 6-month waiting period).

Participants were asked to complete study questionnaires at different timepoints throughout the study to assess their overall satisfaction with the study program and the mental health services that they received. Some participants also completed an interview to discuss their experience in the program.

02

Conditions studied

  • Healthcare Disparities
  • Mental Health

Keywords

  • Social Determinants of Health
  • Minority Health
  • Veterans Health
  • Patient Participation
  • Patient Navigation
  • Mental Health Services
03

In context

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

To be eligible:

  • Must be a Veteran belonging to a racial/ethnic minoritized group
  • Must be actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
  • Must have started receiving mental health care as a new patient in the Outpatient Mental Health within 12 months prior to enrollment into the study

Exclusion criteria

Exclusion Criteria:

Not eligible if:

  • Is a Veteran not belonging to a racial/ethnic minoritized group
  • Not actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
  • Started receiving mental health care as a new patient in the Outpatient Mental Health outside of the 12-month window
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Active PARTNER-MH

    Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.

    Behavioral: PARTNER-MH

  • Other
    Waitlist Control

    The waitlist control arm participants received usual mental health services. They were offered to receive the intervention after the 6-month wait period.

    Behavioral: PARTNER-MH

Interventions

  • BehavioralPARTNER-MH

    The study intervention consisted of a 6-month, manualized, peer-led navigation program. It involved assessing and addressing patients' unmet social needs and barriers to care, delivery of peer support services, navigation to VA mental health services, and psychoeducation.

06

What researchers measure

Primary outcomes

  1. Patient Activation Measure- Mental Health (PAM-MH)

    Measure Description: The PAM-MH is a 13-item questionnaire that measures an individual's perceived ability to manage illness and health behaviors. The questions are rated on a 4-point Likert-type scale (1= strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores are then converted using Rasch analysis to a 100-point scale. Raw scores range from 13 to 52 and converted activation scores range from 0-100. Higher activation scores indicate higher level of patient activation.

    Time frame: Change from Baseline to 6 months

  2. Altarum Consumer Engagement (ACE) Change

    The ACE is administered as a 5-level Likert scale. The subscale scores range from 5 to 25, and the total engagement score is computed by adding the 3 subscale scores and multiplying the sum by 4/3 to obtain a possible range score of 20 to 100. Higher scores represent higher patient engagement.

    Time frame: Change from Baseline to 6 months

  3. SDM-Q9 PARTNER-MH

    The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s SDM-Q-9 informed decision-making scale. The original, validated scale, the SDM-Q-9, has 9 items measured on a 6-point Likert Scale, ranging from 0=completely disagree to 5=completely agree. The total score is calculated by summing the scores of the nine items, range from 0 to 45. A higher score indicates a greater level of perceived SDM.

    Time frame: Change from Baseline to 6 months

  4. Peer Coaching Experience Satisfaction Questionnaire

    Peer Coaching Experience Satisfaction Questionnaire is designed to collect feedback on a respondent's overall experience with a peer coach at the end of a 6-month period. Only participants in active PARTNER-MH were administered this questionnaire. This questionnaire was developed for the study. Question 1: Overall, how satisfied are you with PARTNER-MH program? Question 2: How satisfied are you with your assigned peer. Answers are rated on a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied).

    Time frame: Administered after completion of the study program (6 months for Active PARTNER-MH )

  5. Trust and Satisfaction Survey Responses Change

    The Trust and Satisfaction Survey is a 5-item scale which assess a respondent's degree of trust toward the VA, VA mental health care services, and the study program. Respondents are asked to rate how much they agree with each of the 5 items. Items are rated on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The survey yields final scores ranging from 5 (minimum) to 25 (maximum) with higher scores representing greater trust and satisfaction. No subscale.

    Time frame: Change from Baseline to 6 months

Secondary outcomes

  1. Veteran's RAND 12-item Health Survey (VR-12) Change

    The Veterans Rand 12-item Health Survey (VR-12) is a 12-item scale that assesses Veterans' report of health-related quality of life. It measures mental and physical functioning. The VR-12 uses five-point ordinal response choices and provides two scores: the Physical Component Summary Score and the Mental Health Summary Score, ranging from 0 to 100. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. The scores are compared to the population average, measured in standard deviations. The United States population average PCS and MCS are 50 points each. The United States population standard deviation is 10 points. Higher scores indicate better self-reported health. Lower VR-12 MCS scores indicate worse psychological distress/functioning. Clinically significant scores vary based on the condition or disease population.

    Time frame: Change from Baseline to 6 months

  2. Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change

    The Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) is 5-item scale rated on a 10-point Likert scale ranging from 1 (not confident at all) to 10 (very confident) and the total score, which is the sum of all item ratings, range from 0 (minimum) to 50 (maximum). Higher scores indicate higher levels of self-efficacy. There is no subscale.

    Time frame: Change from Baseline to 6 months

  3. Working Alliance Inventory Short-Revised (WAI-SR) Change

    Working Alliance Inventory -Short Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their mental health providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= seldom to 5= always. The WAI-SR has 3 subscales: The Goal, Task, and Bond subscales each have 4 items and scores ranging from 4 to 20. For research purposes, use of the overall mean scores of the WAI-SR rather than its subscales have been recommended. The scale total scores range from 12 (minimum) to 60 (maximum). Higher scores indicate higher level of working alliance. There is no cut off score for this scale.

    Time frame: Change from Baseline to 6 months

  4. UCLA Loneliness Scale (ULS-6) Change

    The UCLA Loneliness Scale Short Form, (ULS-6), is a 6-item scale that assesses loneliness and is rated on a 4-point Likert Scale, ranging from 1=never to 4= often. The scale has a total summed score ranging from 6 (minimum) to 24 (maximum), with higher scores indicate higher level of loneliness.

    Time frame: Change from Baseline to 6 months

  5. Patient Health Questionnaire (PHQ-9) Change

    Measure Description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It includes 9 items, ranging in scores from 0 to 27. Higher scores indicate more severe symptoms of depression.

    Time frame: Change from Baseline to 6 months

Other outcomes

  1. Lubben Social Network Scale-6

    The Lubben Social Network Scale (LSNS-6) is a self-report measure consisting of 6 items, rated on a 6-point Likert scale ranging 0 to 5. The total score is the sum of all 6 items ranging from 0 to 30. A score of 12 indicates at risk of social isolation and scores less than 12 indicate social isolation.

    Time frame: change in scores from baseline to 6 months

  2. Perceived Discrimination in Healthcare Responses

    Measure Description: Respondents are asked to rate their experiences on a 5-point Likert-type scale, with answers ranging from 0 (never) to 4 (always). Higher scores indicate more frequent experiences of discrimination in healthcare.

    Time frame: Change in score from baseline to 6 months

07

Results

Posted Sep 19, 2024
Limitations and caveats
The study had some limitations that should be considered. The study was conducted with a small sample at one VHA site. It was not powered to detect significant changes. Therefore, findings should be interpreted with caution. The retention rate in the study was also moderate and differed by study group. Future evaluation of PARTNER-MH should also examine outcomes over a longer period to assess patients' health services utilization and engagement in mental health treatment.

Participant flow

Period 1: 6 Month Randomized Period
Participant flow — Period 1: 6 Month Randomized Period
MilestoneActive PARTNER-MHWaitlist Control
Started3020
Completed1818
Not completed122
Withdrew: Lost to follow-up91
Withdrew: Withdrawal by subject31
Period 2. 6 Month Waitlist Crossover
Participant flow — Period 2. 6 Month Waitlist Crossover
MilestoneActive PARTNER-MHWaitlist Control
Started012
Completed07
Not completed05
Withdrew: Lost to follow-up05

Outcome measures

PrimaryPatient Activation Measure- Mental Health (PAM-MH)

Measure Description: The PAM-MH is a 13-item questionnaire that measures an individual's perceived ability to manage illness and health behaviors. The questions are rated on a 4-point Likert-type scale (1= strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores are then converted using Rasch analysis to a 100-point scale. Raw scores range from 13 to 52 and converted activation scores range from 0-100. Higher activation scores indicate higher level of patient activation.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Patient Activation Measure- Mental Health (PAM-MH)
score on a scaleActive PARTNER-MHWaitlist Control
Patient Activation Measure- Mental Health (PAM-MH)5.7 ± 16.59.1 ± 11.7
PrimaryAltarum Consumer Engagement (ACE) Change

The ACE is administered as a 5-level Likert scale. The subscale scores range from 5 to 25, and the total engagement score is computed by adding the 3 subscale scores and multiplying the sum by 4/3 to obtain a possible range score of 20 to 100. Higher scores represent higher patient engagement.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Altarum Consumer Engagement (ACE) Change
score on a scaleActive PARTNER-MHWaitlist Control
Altarum Consumer Engagement (ACE) Change5.5 ± 11.52.9 ± 10.4
PrimarySDM-Q9 PARTNER-MH

The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s SDM-Q-9 informed decision-making scale. The original, validated scale, the SDM-Q-9, has 9 items measured on a 6-point Likert Scale, ranging from 0=completely disagree to 5=completely agree. The total score is calculated by summing the scores of the nine items, range from 0 to 45. A higher score indicates a greater level of perceived SDM.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · units on a scale
SDM-Q9 PARTNER-MH
units on a scaleActive PARTNER-MHWaitlist Control
SDM-Q9 PARTNER-MH1.9 ± 13.51.3 ± 7.1
PrimaryPeer Coaching Experience Satisfaction Questionnaire

Peer Coaching Experience Satisfaction Questionnaire is designed to collect feedback on a respondent's overall experience with a peer coach at the end of a 6-month period. Only participants in active PARTNER-MH were administered this questionnaire. This questionnaire was developed for the study. Question 1: Overall, how satisfied are you with PARTNER-MH program? Question 2: How satisfied are you with your assigned peer. Answers are rated on a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied).

Time frame:
Administered after completion of the study program (6 months for Active PARTNER-MH )
Reported as:
Number · participants
Peer Coaching Experience Satisfaction Questionnaire
participantsActive PARTNER-MH
Question 1 Very satisified6
Question 1 Satisified4
Question 1 Neutral2
Question 1 Dissatisfied1
Question 1 Very dissatisfied1
Question 2 Very satisfied11
Question 2 Satisfied1
Question 2 Neutral1
Question 2 Dissatisfied1
Question 2 Very dissatisfied0
PrimaryTrust and Satisfaction Survey Responses Change

The Trust and Satisfaction Survey is a 5-item scale which assess a respondent's degree of trust toward the VA, VA mental health care services, and the study program. Respondents are asked to rate how much they agree with each of the 5 items. Items are rated on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The survey yields final scores ranging from 5 (minimum) to 25 (maximum) with higher scores representing greater trust and satisfaction. No subscale.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Trust and Satisfaction Survey Responses Change
score on a scaleActive PARTNER-MHWaitlist Control
Trust the VA0.05 ± 0.85-0.13 ± 0.83
Trust the Mental Health Clinic0.03 ± 0.69-0.03 ± 0.65
Would recommend MH clinic0.16 ± 0.87-0.19 ± 0.64
Satisfied with the care I received at MH clinic0.24 ± 0.72-0.53 ± 0.72
SecondaryVeteran's RAND 12-item Health Survey (VR-12) Change

The Veterans Rand 12-item Health Survey (VR-12) is a 12-item scale that assesses Veterans' report of health-related quality of life. It measures mental and physical functioning. The VR-12 uses five-point ordinal response choices and provides two scores: the Physical Component Summary Score and the Mental Health Summary Score, ranging from 0 to 100. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. The scores are compared to the population average, measured in standard deviations. The United States population average PCS and MCS are 50 points each. The United States population standard deviation is 10 points. Higher scores indicate better self-reported health. Lower VR-12 MCS scores indicate worse psychological distress/functioning. Clinically significant scores vary based on the condition or disease population.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Veteran's RAND 12-item Health Survey (VR-12) Change
score on a scaleActive PARTNER-MHWaitlist Control
VR-12 Physical Function-4.4 ± 6.8-0.3 ± 7.8
VR-12 Mental Function8.3 ± 6.5-2.8 ± 6.8
SecondaryPerceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change

The Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) is 5-item scale rated on a 10-point Likert scale ranging from 1 (not confident at all) to 10 (very confident) and the total score, which is the sum of all item ratings, range from 0 (minimum) to 50 (maximum). Higher scores indicate higher levels of self-efficacy. There is no subscale.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
score on a scaleActive PARTNER-MHWaitlist Control
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change6.5 ± 11.51.2 ± 10.2
SecondaryWorking Alliance Inventory Short-Revised (WAI-SR) Change

Working Alliance Inventory -Short Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their mental health providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= seldom to 5= always. The WAI-SR has 3 subscales: The Goal, Task, and Bond subscales each have 4 items and scores ranging from 4 to 20. For research purposes, use of the overall mean scores of the WAI-SR rather than its subscales have been recommended. The scale total scores range from 12 (minimum) to 60 (maximum). Higher scores indicate higher level of working alliance. There is no cut off score for this scale.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · score on a scale
Working Alliance Inventory Short-Revised (WAI-SR) Change
score on a scaleActive PARTNER-MHWaitlist Control
BOND subscale0.7 ± 3.40.7 ± 3.6
GOAL subscale1.6 ± 5.71.6 ± 4.0
TASK Subscale1.4 ± 2.70.7 ± 5.5
Summed scores3.8 ± 9.92.9 ± 10.9
SecondaryUCLA Loneliness Scale (ULS-6) Change

The UCLA Loneliness Scale Short Form, (ULS-6), is a 6-item scale that assesses loneliness and is rated on a 4-point Likert Scale, ranging from 1=never to 4= often. The scale has a total summed score ranging from 6 (minimum) to 24 (maximum), with higher scores indicate higher level of loneliness.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · units on a scale
UCLA Loneliness Scale (ULS-6) Change
units on a scaleActive PARTNER-MHWaitlist Control
UCLA Loneliness Scale (ULS-6) Change-0.6 ± 4.1-0.3 ± 3.9
SecondaryPatient Health Questionnaire (PHQ-9) Change

Measure Description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It includes 9 items, ranging in scores from 0 to 27. Higher scores indicate more severe symptoms of depression.

Time frame:
Change from Baseline to 6 months
Reported as:
Mean · units on a scale
Patient Health Questionnaire (PHQ-9) Change
units on a scaleActive PARTNER-MHWaitlist Control
Patient Health Questionnaire (PHQ-9) Change-3.6 ± 6.70.1 ± 5.2
Other pre-specifiedLubben Social Network Scale-6

The Lubben Social Network Scale (LSNS-6) is a self-report measure consisting of 6 items, rated on a 6-point Likert scale ranging 0 to 5. The total score is the sum of all 6 items ranging from 0 to 30. A score of 12 indicates at risk of social isolation and scores less than 12 indicate social isolation.

Time frame:
change in scores from baseline to 6 months
Reported as:
Mean · score on a scale
Lubben Social Network Scale-6
score on a scaleActive PARTNER-MHWaitlist Control
Lubben Social Network Scale-66.3 ± 7.00.0 ± 2.6
Other pre-specifiedPerceived Discrimination in Healthcare Responses

Measure Description: Respondents are asked to rate their experiences on a 5-point Likert-type scale, with answers ranging from 0 (never) to 4 (always). Higher scores indicate more frequent experiences of discrimination in healthcare.

Time frame:
Change in score from baseline to 6 months
Reported as:
Mean · score on a scale
Perceived Discrimination in Healthcare Responses
score on a scaleActive PARTNER-MHWaitlist Control
Perceived Discrimination in Healthcare Responses-1.9 ± 5.3-1.6 ± 4.5
Post-hocCollaboRATE

CollaboRATE consists of 3-items, each scored on a scale of 0-9. Scores range from 0-100. Higher scores indicate more shared decision.

Time frame:
Change in score from baseline to 6-months
Reported as:
Mean · score on a scale
CollaboRATE
score on a scaleActive PARTNER-MHWaitlist Control
CollaboRATE1.8 ± 8.80.4 ± 6.0

Adverse events

Collected over Adverse events were monitored and assessed from the time of study entry at baseline until the end of study participation at 6 months (primary endpoint), or 12 months for those who were in the waitlist control arm and opted to receive the intervention.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active PARTNER-MH0/30 (0%)0/30 (0%)1/30 (3.3%)
Waitlist Control0/20 (0%)0/20 (0%)0/20 (0%)
Most frequent other events
Most frequent other events
EventActive PARTNER-MHWaitlist Control
non-serious adverse eventPsychiatric disorders1/300/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Active PARTNER-MHWaitlist ControlTotal
<=18 years000
Between 18 and 65 years282048
>=65 years202
Sex: Female, Male
Sex: Female, Male(Participants)Active PARTNER-MHWaitlist ControlTotal
Female81119
Male22931
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Active PARTNER-MHWaitlist ControlTotal
White (Hispanic)303
Black201535
Asian011
Other235
Multiracial516
Hispanic426
Region of Enrollment
Region of Enrollment(Participants)Active PARTNER-MHWaitlist ControlTotal
United States302050
Altarum Consumer Engagement (ACE)
Altarum Consumer Engagement (ACE)(units on a scale)Active PARTNER-MHWaitlist ControlTotal
ACE Commitment subscale13.7 ± 4.713.6 ± 5.913.7 ± 5.2
ACE Informed Choice Subscale10.6 ± 4.810.4 ± 5.410.5 ± 5.0
ACE Navigation Subscale15.5 ± 4.414.8 ± 2.815.2 ± 3.8
Patient Activation Measure (PAM-MH)
Patient Activation Measure (PAM-MH)(units on a scale)Active PARTNER-MHWaitlist ControlTotal
Mean51.5 ± 11.349.6 ± 11.851.5 ± 11.3
Shared-Decision-Making-9 (SDM-Q-9)
Shared-Decision-Making-9 (SDM-Q-9)(units on a scale)Active PARTNER-MHWaitlist ControlTotal
Mean25.8 ± 9.128.3 ± 9.726.8 ± 9.4
Communication Self-Efficacy (PEPPI-5)
Communication Self-Efficacy (PEPPI-5)(units on a scale)Active PARTNER-MHWaitlist ControlTotal
Mean35.2 ± 10.636.4 ± 11.435.7 ± 10.8

9 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    Indianapolis, Indiana 46202-2884, United States
09

References and documents

Publications

  • Eliacin J, Burgess DJ, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Slaven JE, O'Connor C, Walker K, Zou DS, Austin E, Akins J, Miller J, Chinman M, Matthias MS. Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 Sep 6;11(9):e37712. doi: 10.2196/37712. PubMed 36066967 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 7, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Final research datasets underlying all publications reporting results of VA research can be made available, upon FOIA request. Upon request, a limited dataset will be made available for other researchers for the purposes of validation of findings. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent findings and view supplemental details that might not be included in publications.

Supporting information: Study protocol, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04515771
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 17, 2020
Start date
Aug 17, 2020
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

Johanne Eliacin, PhD
principal investigator · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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