Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT01722734
Status:
COMPLETED
Last Update Posted:
2014-03-21
First Post:
2012-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gfink@hsph.harvard.edu', 'phone': '6174327389', 'title': 'Dr Günther Fink', 'organization': 'Harvard School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Main outcome is self-reported adherence. Study was restricted to urban population with mobile phone ownership.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse effects were restricted to the 3 days monitoring period.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients in this group received only a generic malaria message at the end of the study.', 'otherNumAtRisk': 554, 'otherNumAffected': 0, 'seriousNumAtRisk': 554, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Short Message', 'description': 'Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.', 'otherNumAtRisk': 277, 'otherNumAffected': 0, 'seriousNumAtRisk': 277, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Long Message', 'description': 'Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.', 'otherNumAtRisk': 309, 'otherNumAffected': 0, 'seriousNumAtRisk': 309, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.'}, {'id': 'OG001', 'title': 'Short Message', 'description': 'Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.'}, {'id': 'OG002', 'title': 'Long Message', 'description': 'Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '57.39', 'upperLimit': '65.648'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '63.45', 'upperLimit': '74.60'}, {'value': '64.1', 'groupId': 'OG002', 'lowerLimit': '58.72', 'upperLimit': '69.56'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '70 hours', 'description': 'Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.'}, {'id': 'FG001', 'title': 'Short Message', 'description': 'Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.'}, {'id': 'FG002', 'title': 'Long Message', 'description': 'Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '554'}, {'groupId': 'FG001', 'numSubjects': '277'}, {'groupId': 'FG002', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '552'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were recruited at all private and public facilities distributing Artemisinin-combination Therapies (ACTs).', 'preAssignmentDetails': 'Only subjects from the Tamale area with cell phones were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '1140', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.'}, {'id': 'BG001', 'title': 'Short Message', 'description': 'Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.'}, {'id': 'BG002', 'title': 'Long Message', 'description': 'Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '666', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age is reported for the sick person in the household, which includes children in the care of adults, who were enrolled in the study and who received the message treatments.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '23', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '23.8', 'spread': '17.8', 'groupId': 'BG002'}, {'value': '24.3', 'spread': '17.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age reflects age of the patient. For patients of age 18 and younger, caregivers were enrolled and interviewed and thus primary study subjects.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '634', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '506', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ghana', 'categories': [{'measurements': [{'value': '554', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '1140', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2012-11-02', 'resultsFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment', 'timeFrame': '70 hours', 'description': 'Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malaria', 'ACTs'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '25350546', 'type': 'DERIVED', 'citation': 'Raifman JR, Lanthorn HE, Rokicki S, Fink G. The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial. PLoS One. 2014 Oct 28;9(10):e109032. doi: 10.1371/journal.pone.0109032. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system.\n\nStudy hypothesis: text message reminders increase adherence', 'detailedDescription': 'A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system. Patients were enrolled at clinics and pharmacies upon receipt of ACTs and enrolled in the automated system for 3 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-subjects acquiring ACTs in Tamale, Ghana\n\nExclusion Criteria:\n\n* subjects acquiring ACTs for non household members\n* subjects under the age of 18\n* subjects without access to cell phones\n* subjects living more than 30 minutes from pickup location'}, 'identificationModule': {'nctId': 'NCT01722734', 'acronym': 'PACT', 'briefTitle': 'Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment', 'orgStudyIdInfo': {'id': '19850-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control arm only got a generic health message at the end of the study.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short Message', 'description': 'Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.', 'interventionNames': ['Behavioral: Text message reminders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long message', 'description': 'Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.', 'interventionNames': ['Behavioral: Text message reminders']}], 'interventions': [{'name': 'Text message reminders', 'type': 'BEHAVIORAL', 'description': 'Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.', 'armGroupLabels': ['Long message', 'Short Message']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tamale', 'state': 'Northern Region', 'country': 'Ghana', 'facility': 'Study site', 'geoPoint': {'lat': 9.40079, 'lon': -0.8393}}], 'overallOfficials': [{'name': 'Gunther Fink, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of International Health Economics', 'investigatorFullName': 'Günther Fink', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}