EPIC: Point-of-care Health Literacy and Activation Information to Improve Diabetes Care

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01876485
Collaborator
(none)
280
3
2
30.9
93.3
3

Study Details

Study Description

Brief Summary

This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, the investigators will evaluate the process of implementing a collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care [EPIC]) personalized to self-reported patient activation and functional health literacy (FHL) levels into routine primary care practices. In Phase 2, the investigators will conduct a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC). In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of

= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a one-on-one session between a designated PACT member and patient participants will focus on collaborative goal-setting. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Study measurements using self-reported questionnaires and blood tests to assess blood sugar control will be obtained at baseline, post-intervention, and post-six month maintenance period.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Empowering Patients in Chronic Care (EPIC)
  • Behavioral: Enhanced Usual Care (EUC)
N/A

Detailed Description

Project Background: Diabetes mellitus is a highly prevalent chronic condition, affecting one in four Veterans who use the Veterans Affairs (VA) health care system. Self-management skills are critical for controlling diabetes and reducing its cardiovascular sequela. Providing diabetic patients with effective self-management training and support can be challenging due to time constraints at primary care encounters and limited clinician training with behavior change. The investigators have previously demonstrated that a group-based, VA primary care intervention to help patients set highly effective, evidence-based diabetes goals had a positive impact on both diabetes self-efficacy and hemoglobin (Hb) A1c levels. This study aims to evaluate the process of implementing a collaborative goal-setting intervention personalized to patient activation and health literacy levels (i.e. Empowering Patients in Chronic Care [EPIC]) into routine PACT care and to evaluate the effectiveness of this intervention relative to usual care.

Project Objectives: Specific Aim 1: Assess effective processes for and costs associated with implementing a collaborative diabetes goal-setting intervention personalized to patient activation and FHL (i.e., EPIC) into the routine workflows of PACTs. H1: Formative measures within the PARIHS framework (evidence, context, facilitation) will be associated with implementation of EPIC (defined by reach, adoption, cost effectiveness, and fidelity measures) into routine PACT care. Specific Aim 2: Evaluate the effectiveness of delivering collaborative goal-setting personalized to patient activation and FHL on clinical (HbA1c) and patient-centered (Diabetes Distress Scale) outcomes among eligible patients in enrolled PACTs. H2: Patients receiving collaborative goal-setting personalized to activation and FHL levels will have significant improvements in a) HbA1c and b) Diabetes Distress Scale levels, respectively, at post-intervention compared with patients receiving enhanced usual care. H3: Patients receiving collaborative goal-setting personalized to activation and FHL levels will maintain significant improvements in a) HbA1c and b) Diabetes Distress Scale levels at post-maintenance follow-up, respectively, compared with patients receiving enhanced usual care.

Project Methods: In Phase 1 of the study, the investigators will implement EPIC into routine PACT care. The investigators will conduct a mixed-methods formative evaluation that includes 33-48 key informant interviews with VA leadership, clinicians, and staff and an assessment of organizational readiness for change. This evaluation will identify how group and one-on-one sessions of EPIC can best be implemented into routine workflows of PACT. In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 patients with poorly controlled diabetes defined by average hemoglobin A1c of 8% to receive EPIC or enhanced usual care. The patient will serve as the unit of randomization. EPIC consists of six 1-hour group sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a one-on-one session between a designated PACT member and patient participants will focus on collaborative goal-setting. Designated PACT members will be trained to personalize goal-setting using patient-reported activation and health literacy data. The investigators will collect laboratory and survey data at baseline, post-intervention, and post-maintenance phase. The investigators will evaluate the effectiveness of personalized goal-setting compared to enhanced usual care on clinical (e.g., hemoglobin A1c) and patient-centered (e.g., Diabetes Distress Scale) outcomes.

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Actual Study Start Date :
Jul 13, 2015
Actual Primary Completion Date :
Feb 9, 2018
Actual Study Completion Date :
Feb 9, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Empowering Patients in Chronic Care (EPIC)

Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.

Behavioral: Empowering Patients in Chronic Care (EPIC)
EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.

Active Comparator: Arm 2: Enhanced Usual Care (EUC)

The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.

Behavioral: Enhanced Usual Care (EUC)
Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.

Outcome Measures

Primary Outcome Measures

  1. Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention [HbA1c levels will be measured at baseline, four months, and ten months.]

    Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.

  2. Change in Diabetes Specific Quality of Life [Diabetes specific quality of life will be measured at baseline, four months, and ten months.]

    The Diabetes Distress Scale (DDS) will be used to assess diabetes quality of life throughout the study. Minimum value: 1; Maximum value: 6. Higher scores indicate a higher level of diabetes distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Veterans receiving primary care at VA study sites who are enrolled in the panels of participating primary care teams

  • Veterans with ICD-9-CM and/or ICD-10 codes indicating a diagnosis of diabetes

  • Veterans with an average HbA1c level > 8% in the prior 6 months

Exclusion Criteria:

The investigators will exclude Veterans with the following clinical conditions that would render participation in a group clinic inappropriate:

  • metastatic cancer or receiving hospice care

  • limited life expectancy

  • clinician recommendations to not titrate therapy due to prior history of significant hypoglycemic events

  • age <18 years

  • active bipolar or psychotic disorder

The investigators will also exclude Veterans, who at the time of screening:
  • cannot attend monthly group clinic sessions due to transportation or availability barriers

  • have significant cognitive impairment

  • have active substance-abuse disorders

  • are not comfortable discussing their health and health care in a peer-group setting Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jesse Brown VA Medical Center, Chicago, IL Chicago Illinois United States 60612
2 Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois United States 60141-5000
3 Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas United States 77030

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: LeChauncy D. Woodard, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01876485
Other Study ID Numbers:
  • CRE 12-426
First Posted:
Jun 12, 2013
Last Update Posted:
Jun 19, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Arm/Group Description Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the Patient Aligned Care Team (PACT) Registered Nurse (RN) Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Period Title: Overall Study
STARTED 140 140
Post-Intervention 125 129
Maintenance 116 114
COMPLETED 116 114
NOT COMPLETED 24 26

Baseline Characteristics

Arm/Group Title Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC) Total
Arm/Group Description Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Total of all reporting groups
Overall Participants 140 140 280
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
46
32.9%
49
35%
95
33.9%
>=65 years
94
67.1%
91
65%
185
66.1%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
67.39
(8.57)
66.94
(8.34)
67.17
(8.44)
Sex: Female, Male (Count of Participants)
Female
9
6.4%
7
5%
16
5.7%
Male
131
93.6%
133
95%
264
94.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
22
15.7%
11
7.9%
33
11.8%
Not Hispanic or Latino
116
82.9%
125
89.3%
241
86.1%
Unknown or Not Reported
2
1.4%
4
2.9%
6
2.1%
Region of Enrollment (Count of Participants)
United States
140
100%
140
100%
280
100%
Percent Glycosylated Hemoglobin (HbA1c) (Percent/DCCT) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent/DCCT]
9.11
(1.60)
9.06
(1.32)
9.08
(1.46)
Diabetes Distress Scale (DDS) (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]
2.41
(1.05)
2.45
(1.02)
2.43
(1.03)

Outcome Measures

1. Primary Outcome
Title Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention
Description Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.
Time Frame HbA1c levels will be measured at baseline, four months, and ten months.

Outcome Measure Data

Analysis Population Description
Although not all of the 140 per group with HbA1c at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full 140 across time points.
Arm/Group Title Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Arm/Group Description Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Measure Participants 140 140
Baseline
9.11
(1.60)
9.06
(1.32)
4 Months
8.61
(1.27)
9.04
(1.70)
10 Months
8.68
(1.53)
8.79
(1.55)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Empowering Patients in Chronic Care (EPIC), Arm 2: Enhanced Usual Care (EUC)
Comments We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate. Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method proc mixed in SAS (multilevel modeling)
Comments Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Empowering Patients in Chronic Care (EPIC), Arm 2: Enhanced Usual Care (EUC)
Comments We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate. Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .60
Comments
Method proc mixed in SAS (multilevel modeling)
Comments Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .11
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Change in Diabetes Specific Quality of Life
Description The Diabetes Distress Scale (DDS) will be used to assess diabetes quality of life throughout the study. Minimum value: 1; Maximum value: 6. Higher scores indicate a higher level of diabetes distress.
Time Frame Diabetes specific quality of life will be measured at baseline, four months, and ten months.

Outcome Measure Data

Analysis Population Description
Seven participants did not complete the DDS at baseline. Therefore, sample sizes for DDS are lower than for HbA1c. Although not all of the 138/135 per group with DDS at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full number across time points.
Arm/Group Title Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Arm/Group Description Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Measure Participants 138 135
Baseline
2.41
(1.05)
2.45
(1.02)
4 Months
2.02
(0.81)
2.30
(0.99)
10 Months
1.96
(0.76)
2.27
(1.05)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Empowering Patients in Chronic Care (EPIC), Arm 2: Enhanced Usual Care (EUC)
Comments We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method proc mixed in SAS (multilevel modeling)
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Empowering Patients in Chronic Care (EPIC), Arm 2: Enhanced Usual Care (EUC)
Comments We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .003
Comments
Method proc mixed in SAS (multilevel modeling)
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .32
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame Adverse event data were collected from 7/13/2015 to 2/9/2018 (from study initiation to study completion).
Adverse Event Reporting Description
Arm/Group Title Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Arm/Group Description Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans. The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
All Cause Mortality
Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/140 (0%) 4/140 (2.9%)
Serious Adverse Events
Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/140 (0%) 0/140 (0%)
Other (Not Including Serious) Adverse Events
Arm 1: Empowering Patients in Chronic Care (EPIC) Arm 2: Enhanced Usual Care (EUC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/140 (0%) 0/140 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. LeChauncy Woodard
Organization Department of Veterans Affairs
Phone (713) 440-4441
Email woodard.lechauncy@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01876485
Other Study ID Numbers:
  • CRE 12-426
First Posted:
Jun 12, 2013
Last Update Posted:
Jun 19, 2019
Last Verified:
Mar 1, 2019