Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT01730235
Status:
COMPLETED
Last Update Posted:
2012-11-21
First Post:
2012-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
My MediHealth: A Paradigm for Children-centered Medication Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-14', 'studyFirstSubmitDate': '2012-11-08', 'studyFirstSubmitQcDate': '2012-11-14', 'lastUpdatePostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline asthma self efficacy after 3 weeks', 'timeFrame': 'participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.', 'description': 'Will assess self-efficacy using the survey by Bursch and colleagues (1997)'}], 'secondaryOutcomes': [{'measure': 'Change in medication adherence after 3 weeks', 'timeFrame': 'Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks', 'description': 'At the end of the 2-week data collection period (following the 1-week test period), all participants (Control and Intervention) and their parents will be asked to complete a brief online survey, including the Asthma Control Test (ACT) and the weekly adherence survey(SDSCA). All responses collected from participants and their parents in the Time 2 Survey will be compared to those collected from the Baseline Survey, where applicable. Medication adherence will be measured by responses to ACT and SDSCA survey items for all participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '26661717', 'type': 'DERIVED', 'citation': 'Johnson KB, Patterson BL, Ho YX, Chen Q, Nian H, Davison CL, Slagle J, Mulvaney SA. The feasibility of text reminders to improve medication adherence in adolescents with asthma. J Am Med Inform Assoc. 2016 May;23(3):449-55. doi: 10.1093/jamia/ocv158. Epub 2015 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at least one daily medication.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Access to the internet Caregiver agrees to let child use the Internet for the project Internet service working properly Legal guardian approves of study Child with her or his own cell phone\n\nExclusion Criteria:\n\n* non English or spanish speaking family'}, 'identificationModule': {'nctId': 'NCT01730235', 'acronym': 'mymedihealth', 'briefTitle': 'My MediHealth: A Paradigm for Children-centered Medication Management', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'My MediHealth: A Paradigm for Children-centered Medication Management', 'orgStudyIdInfo': {'id': 'R18HS018168', 'link': 'https://reporter.nih.gov/quickSearch/R18HS018168', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Group', 'description': 'Group receiving access to MyMediHealth web site.'}, {'label': 'Control Group', 'description': 'Children completing baseline and week two measures, but without any additional intervention.', 'interventionNames': ['Other: MyMediHealth access']}], 'interventions': [{'name': 'MyMediHealth access', 'type': 'OTHER', 'description': 'Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Vandebilt Monroe Carell Children's Hospital", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Biomedical Informatics', 'investigatorFullName': 'Kevin Johnson', 'investigatorAffiliation': 'Vanderbilt University'}}}}