Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT01020851
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2009-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D002545', 'term': 'Brain Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083362', 'term': 'Transtheoretical Model'}], 'ancestors': [{'id': 'D000083342', 'term': 'Health Belief Model'}, {'id': 'D008962', 'term': 'Models, Theoretical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008960', 'term': 'Models, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'cholesterol', 'timeFrame': '6 months'}, {'measure': 'dietary adherence', 'timeFrame': '6 months'}, {'measure': 'exercise adherence', 'timeFrame': '6 months'}, {'measure': 'medication adherence', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'stroke', 'cholesterol', 'adherence'], 'conditions': ['Stroke', 'Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': '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. By a randomized controlled trial, the investigators will test whether a tailored, telephone-delivered transtheoretical model-based behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo.\n\nThe primary specific aims of this project are to:\n\n* determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA\n* assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA.\n\nSecondary aims are to\n\n* assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months\n* evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA\n* determine whether the TI is effective in improving adherence to exercise recommendations after 6 months.\n\nTo answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 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': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Well-documented history of stroke or TIA\n* Age 21 years or older\n* Continuity of care in the 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 time to 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 within the next 6 months\n* Inability to communicate over the telephone due to severe cognitive impairment or aphasia'}, 'identificationModule': {'nctId': 'NCT01020851', 'acronym': 'PREVENTS', 'briefTitle': 'The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial', 'organization': {'class': 'OTHER', 'fullName': 'Narrows Institute for Biomedical Research'}, 'officialTitle': 'The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial', 'orgStudyIdInfo': {'id': 'AHA0835195N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tailored intervention', 'description': 'Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.', 'interventionNames': ['Behavioral: tailored intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'attention placebo', 'description': 'Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics', 'interventionNames': ['Behavioral: attention placebo']}], 'interventions': [{'name': 'tailored intervention', 'type': 'BEHAVIORAL', 'otherNames': ['stage-matched intervention', 'transtheoretical model'], 'description': '6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model', 'armGroupLabels': ['tailored intervention']}, {'name': 'attention placebo', 'type': 'BEHAVIORAL', 'description': '6 monthly telephone-delivered sessions focusing on general health topics', 'armGroupLabels': ['attention placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System, NY and Brooklyn Campuses', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Narrows Institute for Biomedical Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Jennifer Friedberg', 'investigatorAffiliation': 'Narrows Institute for Biomedical Research'}}}}