Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-02-06 @ 5:48 AM
Study NCT ID:
NCT02012712
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personal Health Records and Elder Medication Use Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean (SD) number of prescription drugs', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Mean (SD) number of over-the-counter drugs', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Any change in medication use in past 3 months', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Started prescription drug', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Stopped prescription drug', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Changed strength/dose of prescription drug', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Keep list of current medications', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Reason for medications on list', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Usually shows medication list to doctor', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Put over-the-counter drugs on list', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Updated list in past 3 months', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'At last doctor visit, asked whether keep a medication list', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'At last doctor visit, had medication list', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'At last doctor visit showed medication list', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Someone asked about medication strength at last doctor visit (for all medications)', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Someone asked about medication strength at last doctor visit (for some medications)', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'At last doctor visit, doctor compared records with what patient said they were taking', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'At last doctor visit, differences found between doctor and patient medication records', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Use of potentially inappropriate medications (ACOVE)', 'timeFrame': 'Baseline and 6 months', 'description': 'List of potentially inappropriate medications derived from the Assessing Care of Vulnerable Elders project (ACOVE-3)\n\nShrank WH, Polinski JM, Avorn J. Quality Indicators for Medication Use in Vulnerable Elders. J Am Geriatr Soc 2007;55:S373-S382.'}, {'measure': 'Taking 2 or more NSAIDS (including aspirin)', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Mean (SD) number of medication management problems', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Knows how to recognize side effects', 'timeFrame': '6 months'}, {'measure': 'Medication side effects in past 3 months', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Mean (SD) modified Morisky adherence score', 'timeFrame': 'Baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Personal health record', 'medication management', 'patient safety'], 'conditions': ['Adverse Reaction to Drug', 'Health Behavior', 'Medication Adherence', 'Physician-Patient Relations']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Hourcade, J.P., Chrischilles, E.A., Gryzlak, B.M., Hanson, B.M., Dunbar, D.E., Eichmann, D.A. and Lorentzen, R.R. (2011). Design Lessons for Older Adult Personal Health Records Software from Older Adults. Proceedings of 6th International Conference on Universal Access in Human-Computer Interaction, held as part of HCI International. Lecture Notes in Computer Science, 6766, 176-85.'}, {'pmid': '20697465', 'type': 'BACKGROUND', 'citation': 'Witry MJ, Doucette WR, Daly JM, Levy BT, Chrischilles EA. Family physician perceptions of personal health records. Perspect Health Inf Manag. 2010 Jan 1;7(Winter):1d.'}, {'pmid': '24326536', 'type': 'RESULT', 'citation': 'Chrischilles EA, Hourcade JP, Doucette W, Eichmann D, Gryzlak B, Lorentzen R, Wright K, Letuchy E, Mueller M, Farris K, Levy B. Personal health records: a randomized trial of effects on elder medication safety. J Am Med Inform Assoc. 2014 Jul-Aug;21(4):679-86. doi: 10.1136/amiajnl-2013-002284. Epub 2013 Dec 10.'}], 'seeAlsoLinks': [{'url': 'http://link.springer.com/chapter/10.1007%2F978-3-642-21663-3_19', 'label': '\\[Manuscript\\] Design Lessons for Older Adult Personal Health Records Software from Older Adults'}, {'url': 'http://healthit.ahrq.gov/ahrq-funded-projects/personal-health-records-and-elder-medication-use-quality', 'label': 'Project final report'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To examine the impact of a personal health record (PHR) on medication use safety among older adults.\n\nBackground: Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have.\n\nMethods: A PHR was designed and pretested with older adults and tested in a six-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Computer use within the past month.\n* Age 65+'}, 'identificationModule': {'nctId': 'NCT02012712', 'briefTitle': 'Personal Health Records and Elder Medication Use Quality', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Personal Health Records and Elder Medication Use Quality', 'orgStudyIdInfo': {'id': '200708714'}, 'secondaryIdInfos': [{'id': 'R18HS017034', 'link': 'https://reporter.nih.gov/quickSearch/R18HS017034', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personal Health Record (PHR)', 'description': 'Subjects were sent an invitation to use an online Personal Health Record (PHR)', 'interventionNames': ['Behavioral: Personal Health Record (PHR)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Subjects received usual care (no invitation or access to the study PHR)'}], 'interventions': [{'name': 'Personal Health Record (PHR)', 'type': 'BEHAVIORAL', 'description': 'Iowa PHR is a Web-based application that features a tabbed interface design. Users can enter, view, and print their current and past medicines, allergies, health conditions, and health event tracking over time. An embedded tutorial video provides assistance with the system. The PHR was developed and refined using participatory design and focus group sessions as well as evaluation in a usability laboratory. The resulting design emphasizes the reduction of physical and cognitive demands on users, focusing on simplicity, readability, and quick navigation.\n\nIowa PHR displayed a message when a user entered a medication with an associated Assessing Care of Vulnerable Elders project (ACOVE-3) safety concern. This included 16 safety issues for 12 drugs or drug classes with safety concerns. We also adapted four general medication use patient safety indicators from the ACOVE project and displayed them to all users on a rotating basis upon login.', 'armGroupLabels': ['Personal Health Record (PHR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Elizabeth A Chrischilles, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elizabeth A Chrischilles', 'investigatorAffiliation': 'University of Iowa'}}}}