Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-09 @ 6:16 PM
Study NCT ID:
NCT02908893
Status:
UNKNOWN
Last Update Posted:
2016-10-21
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Flu Vaccination Through a Mobile Wellness Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77983}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-20', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in vaccination rate vs control', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Increase in vaccination rate of anyone messaged relative to the control condition'}, {'measure': 'Increase in vaccination rate of salient vs non-salient', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Increase in vaccination rate of those who received salient incentives messages vs those who received generic messages'}], 'secondaryOutcomes': [{'measure': 'Decrease in medically attended flu events of messaged vs control', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Decrease in observed flu rate for messaged users'}, {'measure': 'Increase in reporting of flu vaccination through wellness app of salient vs non-salient', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Increase in reporting vaccination through the wellness program app following messages'}, {'measure': 'Increase in vaccination rate for users messaged within 2 days before of an expected rx pick-up.', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Increase in vaccination rate of users messaged within 2 days before an expected Rx pick up from a pharmacy relative to their paired partners.'}, {'measure': 'Increase in message open rate of Salient vs Non-salient arm', 'timeFrame': 'Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)', 'description': 'Increase in open rate of sent messages through the wellness program app of salient vs non salient arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Not Condition-specific']}, 'referencesModule': {'references': [{'pmid': '31787410', 'type': 'DERIVED', 'citation': 'Lee WN, Stuck D, Konty K, Rivers C, Brown CR, Zbikowski SM, Foschini L. Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial. Vaccine. 2020 Apr 16;38(18):3508-3514. doi: 10.1016/j.vaccine.2019.11.053. Epub 2019 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among fully insured members of a national payer that participate in a wellness program offered by the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination rate as measured by the insurer and engagement with the campaign through the app.\n\nThe goal of the research is to assess the effectiveness of pervasive computing messaging in promoting preventative care treatments such as flu shots. An additional goal is that of quantifying the importance of emphasizing incentives to increase efficacy of the messages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* belongs to fully insured population\n* continuous health coverage between January 1, 2015 and June 1, 2016\n* has downloaded and installed the wellness platform app\n\nExclusion Criteria:\n\n* has declined the messaging from the platform'}, 'identificationModule': {'nctId': 'NCT02908893', 'briefTitle': 'Promoting Flu Vaccination Through a Mobile Wellness Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Evidation Health'}, 'officialTitle': 'Promoting Flu Vaccination Through a Mobile Wellness Program', 'orgStudyIdInfo': {'id': 'EH-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salient', 'description': 'Messages in the salient arm highlight the number of incentives (points) received by getting a flu shot and recording it through the wellness program app.\n\nAdditionally, messages mention that flu shots can be received at the pharmacy while picking up an Rx.\n\nUsers in the arm are matched up with a second user from the same arm, randomly. For each pair, the messages are sent to both users at the same time within the specified time window. Such time is picked to be the day in which the first user is most likely to pick up an Rx from a pharmacy.', 'interventionNames': ['Behavioral: In-app and push notification mobile messages']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NonSalient', 'description': 'Messages in the non-salient arm highlight the benefits of getting vaccinated against flu, but make no mention of incentives received for getting vaccinated.\n\nIncentives would still be earned through the wellness program if the vaccination is recorded. Messages mention that flu shots can be received at the pharmacy while picking up an Rx.\n\nUsers in the arm are matched up with a second user from the same arm, randomly. For each pair, the messages are sent to both users at the same time within the specified time window. Such time is picked to be the day in which the first user is most likely to pick up an Rx from a pharmacy', 'interventionNames': ['Behavioral: In-app and push notification mobile messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Users in this group will not receive any message promoting flu vaccination. Incentives would still be earned through the wellness program if the vaccination is recorded.'}], 'interventions': [{'name': 'In-app and push notification mobile messages', 'type': 'BEHAVIORAL', 'description': 'Short messages (100-250 characters) are to be delivered to a mobile app both by push notification (i.e., appearing on the phone dashboard like a text message if the user has allowed notifications from the app) and in-app messages (visible in the news feed of the wellness program app when the app is opened). Messages contain a short title (30 characters) and 2-3 lines of text in the body (30 characters each).', 'armGroupLabels': ['NonSalient', 'Salient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93101', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Evidation Health', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Aggregated outcome data may be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evidation Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Defense Advanced Research Projects Agency', 'class': 'FED'}, {'name': 'Army Research Office (ARO)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Data Scientist', 'investigatorFullName': 'Luca Foschini', 'investigatorAffiliation': 'Evidation Health'}}}}