Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
Study NCT ID:
NCT01122394
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Risk of Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.friedberg@va.gov', 'phone': '212-951-3314', 'title': 'Jennifer Friedberg, Ph.D.', 'organization': 'VA New York Harbor Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model', 'otherNumAtRisk': 66, 'otherNumAffected': 9, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)', 'otherNumAtRisk': 74, 'otherNumAffected': 9, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Broken bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Torn Ligament', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone/Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Bypass Graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored intervention based on the transtheoretical model\n\nTI: Tailored intervention based on the transtheoretical model'}, {'id': 'OG001', 'title': 'Attention Placebo (AP)', 'description': 'Attention Placebo\n\nAP: Attention placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '130.83', 'groupId': 'OG000', 'lowerLimit': '119.5', 'upperLimit': '144.83'}, {'value': '133.67', 'groupId': 'OG001', 'lowerLimit': '114.5', 'upperLimit': '144.0'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Robust regressions were performed', 'statisticalMethod': 'robust regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'controlling for provider clustering', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment'}, {'type': 'SECONDARY', 'title': 'Dietary Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'OG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}], 'classes': [{'title': 'pre-action', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Action or Maintenance', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'This analysis includes participants in pre-action and action/maintenance', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol/High Density Lipoprotein Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'OG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.47', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.25'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.81'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Exercise Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'OG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '5.25'}, {'value': '2.75', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Measured by 7-day Physical Activity Recall', 'unitOfMeasure': 'hours per week of cardio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antihypertensive/ Lipid-lowering Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'OG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.58', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'FG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from a prior American Heart Association-funded study testing the effectiveness of a 6-mo TI vs. AP. Participants were recruited at completion of the AHA study to participate in the current study for an additional 6 months. They continued to receive the intervention to which they were originally assigned in the AHA study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored Intervention (TI)', 'description': 'Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model'}, {'id': 'BG001', 'title': 'Attention Placebo (AP)', 'description': 'General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.38', 'spread': '9.86', 'groupId': 'BG000'}, {'value': '68.73', 'spread': '10.30', 'groupId': 'BG001'}, {'value': '67.62', 'spread': '10.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White (non-Hispanic)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American (non-Hispanic)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Refused', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2010-05-10', 'resultsFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-26', 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Dietary Sodium', 'timeFrame': '6 months', 'description': 'self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)'}, {'measure': 'Total Cholesterol/High Density Lipoprotein Ratio', 'timeFrame': '6 months'}, {'measure': 'Exercise Adherence', 'timeFrame': '6 months', 'description': 'Measured by 7-day Physical Activity Recall'}, {'measure': 'Antihypertensive/ Lipid-lowering Medication Adherence', 'timeFrame': '6 months', 'description': 'Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'recurrence', 'blood pressure', 'prevention'], 'conditions': ['Stroke', 'TIA', 'Hypertension', 'Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for having a second serious event, especially if they have uncontrolled blood pressure or cholesterol. However, many patients have difficulty following treatment recommendations for lowering blood pressure and cholesterol. The purpose of this research project is to evaluate the effect of 2 booster sessions of an educational counseling intervention on how well adults who have already participated in a 6-month clinical trial had a stroke or transient ischemic attack (TIA) are able to follow a treatment plan and control their blood pressure and cholesterol levels. We will also examine how effective this intervention is in improving adherence to diet, medication, and physical activity recommendations for adults who have had a prior stroke or TIA.', 'detailedDescription': 'National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to \\<120 mm Hg systolic BP and \\<80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. We will determine whether a telephone-delivered behaviorally tailored intervention (TI) can lead to sustained change resulting in (a) BP and lipid control and (b) improved adherence to diet, medication, and exercise recommendations in veterans with a history of stroke or TIA compared to an attention placebo (AP) in veterans who have completed 6 months of a clinical trial. In this CDA project, we evaluate the long-term effectiveness of booster sessions in a randomized manner. One arm will receive 6 months of a tailored intervention (TI) followed by two booster TI sessions at 8 and 10 months, and one arm will receive 6 months of an attention placebo (AP) followed by two booster AP sessions at 8 and 10 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment;\n* Age 21 years or older;\n* Continuity of care in the VAMC primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year;\n* On hypertensive and/or lipid-lowering agents;\n* A score of \\>16 on the Mini-Mental Status Exam;\n* ability to exercise (assessed by 6-minute walk or timed get up and go).\n\nExclusion Criteria:\n\n* Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer;\n* No telephone number at which patient can be reached;\n* Plans to relocate outside of the NYC area within the next 6 months;\n* Inability to communicate over the telephone due to severe cognitive impairment or aphasia.'}, 'identificationModule': {'nctId': 'NCT01122394', 'acronym': 'RRR', 'briefTitle': 'Reducing Risk of Recurrence', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)', 'orgStudyIdInfo': {'id': 'CDP 09-414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Intervention (TI)', 'description': 'Tailored intervention based on the transtheoretical model', 'interventionNames': ['Behavioral: TI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Attention Placebo (AP)', 'description': 'Attention Placebo', 'interventionNames': ['Behavioral: AP']}], 'interventions': [{'name': 'TI', 'type': 'BEHAVIORAL', 'description': 'Tailored intervention based on the transtheoretical model', 'armGroupLabels': ['Tailored Intervention (TI)']}, {'name': 'AP', 'type': 'BEHAVIORAL', 'description': 'Attention placebo', 'armGroupLabels': ['Attention Placebo (AP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jennifer P Friedberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}