Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-24 @ 12:11 AM
Study NCT ID:
NCT03022669
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Strategies for Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in medication adherence over 12 months', 'timeFrame': '12 months', 'description': 'Medication Event Monitoring System (MEMS) which is an electronic pill bottle cap that captures medication taking patterns'}, {'measure': 'Change in medication adherence over 12 months', 'timeFrame': '12 months', 'description': 'Adherence to Refills and Medications Scale (ARMS)- There are two subscale scores for medication taking and medication refills. The total score is found by adding both subscales. Scores can range from 12 to 48 with 12 being completely medication adherent and 48 being completely non-adherent.'}, {'measure': 'Change in medication adherence at 12 months', 'timeFrame': '12 months', 'description': 'Medication recall questionnaire that will assess how many missed doses there were.'}, {'measure': 'Change in medication adherence at 12 months', 'timeFrame': '12 months', 'description': 'VA Corporate Data Warehouse refill data (Veteran participants)'}, {'measure': 'Change in medication adherence at 12 months', 'timeFrame': '12 months', 'description': 'Peoplechart Meds Incontext refill data (non-Veteran participants)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile health', 'veterans', 'cardiovascular disease', 'medication adherence'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '28720557', 'type': 'DERIVED', 'citation': 'Park LG, Collins EG, Shim JK, Whooley MA. Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2017 Jul 18;6(7):e134. doi: 10.2196/resprot.7327.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether text messages/messaging (TM) or a mobile application (app), compared with an educational website-control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome or percutaneous coronary intervention (ACS/PCI).', 'detailedDescription': 'Adherence to antiplatelet medications is critical to prevent life threatening complications (i.e., stent thrombosis); yet rates of non-adherence range from 21-57% by 12 months. Mobile technology through TM or mobile apps is a practical and inexpensive strategy to promote behavior change and enhance medication adherence. The three specific aims of this proposal are to: 1) determine preferences for content and frequency of TM to promote medication adherence through focus groups; 2) determine the most patient-centered app to promote adherence through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and 3) compare adherence to antiplatelet medications in 225 Veterans post ACS/PCI through a randomized controlled trial. Participants will be randomized to either TM, mobile app, or website-control group. The focus groups will be stratified by low/high mobile phone use and sex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 21 years of age,\n* recent ACS or PCI within 1 week\n* new antiplatelet (thienopyridine) prescription\n* owns a smartphone\n\nExclusion Criteria:\n\n* cognitive impairment\n* lack of English proficiency/literacy'}, 'identificationModule': {'nctId': 'NCT03022669', 'briefTitle': 'Mobile Health Strategies for Veterans', 'organization': {'class': 'FED', 'fullName': 'San Francisco Veterans Affairs Medical Center'}, 'officialTitle': 'Mobile Health Strategies for Veterans With Coronary Heart Disease', 'orgStudyIdInfo': {'id': 'NRI 15-455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text Message Group', 'description': 'The "TM group" will use the VA "Annie" text messaging program to remind patients to take antiplatelet medications. The content for the text messages will be determined through preliminary focus groups that will be conducted prior to the RCT.', 'interventionNames': ['Behavioral: Text Message', 'Other: Website']}, {'type': 'EXPERIMENTAL', 'label': 'Application Group', 'description': 'The "App group" will use a mobile application to remind patients to take antiplatelet medications. The commercially available mobile app will be selected by participants through preliminary focus groups that will be conducted prior to the RCT.', 'interventionNames': ['Behavioral: Mobile Application', 'Other: Website']}, {'type': 'EXPERIMENTAL', 'label': 'Website-Control', 'description': 'The "Website-Control group" will will be offered the American Heart Association patient education website (My Life Check - 7 Steps To Healthy Living) and will serve as an "attention-control." The website will be offered to participants in all three groups. The "7 small steps to big changes" are to manage blood pressure, control cholesterol, reduce blood sugar, get active, eat better, lose weight, and stop smoking.', 'interventionNames': ['Other: Website']}], 'interventions': [{'name': 'Text Message', 'type': 'BEHAVIORAL', 'description': 'Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)', 'armGroupLabels': ['Text Message Group']}, {'name': 'Mobile Application', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Application Group']}, {'name': 'Website', 'type': 'OTHER', 'description': 'American Heart Association patient education website', 'armGroupLabels': ['Application Group', 'Text Message Group', 'Website-Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94520', 'city': 'Concord', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'facility': 'John Muir Medical Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'facility': 'San Francisco Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'facility': 'North Florida/South Georgia Veterans Health System', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'facility': 'VA North Texas Health Care System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Linda Park, PhD, MS, FNP', 'role': 'CONTACT', 'email': 'Linda.Park@ucsf.edu'}, {'name': 'Julia von Oppenfeld', 'role': 'CONTACT', 'email': 'Julia.vonOppenfeld@va.gov', 'phone': '415-676-1153'}], 'overallOfficials': [{'name': 'Linda Park, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco Veterans Medical Center; University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'John Muir Medical Center', 'class': 'UNKNOWN'}, {'name': 'North Florida/South Georgia Veterans Health System', 'class': 'OTHER'}, {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Linda Park', 'investigatorAffiliation': 'University of California, San Francisco'}}}}