Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-01-06 @ 4:29 PM
Study NCT ID:
NCT01823861
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2013-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Technology for Improved Family Planning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christopher.smith@lshtm.ac.uk', 'phone': '07974562199', 'title': 'Dr. Chris Smith', 'organization': 'London School of Hygiene and Tropical Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mobile Phone-based Intervention', 'description': 'Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.\n\nMobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.', 'otherNumAtRisk': 249, 'otherNumAffected': 0, 'seriousNumAtRisk': 249, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care', 'description': "Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.", 'otherNumAtRisk': 251, 'otherNumAffected': 0, 'seriousNumAtRisk': 251, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Use of a Effective Contraceptive Method at Four-months Post-abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Phone-based Intervention', 'description': 'Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.\n\nMobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.'}, {'id': 'OG001', 'title': 'Standard Care', 'description': "Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number."}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pregnancy', 'timeFrame': '4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Repeat Abortion', 'timeFrame': '4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Contraceptive Discontinuation', 'timeFrame': '4 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile Phone-based Intervention', 'description': 'Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.\n\nMobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.'}, {'id': 'FG001', 'title': 'Standard Care', 'description': "Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number."}], 'periods': [{'title': '4 Month Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}, {'title': '12 Month Follow up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '61'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile Phone-based Intervention', 'description': 'Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.\n\nMobile phone-based intervention: Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.'}, {'id': 'BG001', 'title': 'Standard Care', 'description': "Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<25', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': '≥25', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2013-03-30', 'resultsFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2013-03-30', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-02', 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of a Effective Contraceptive Method at Four-months Post-abortion', 'timeFrame': '4 months', 'description': 'Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': '4 months'}, {'measure': 'Repeat Abortion', 'timeFrame': '4 months'}, {'measure': 'Contraceptive Discontinuation', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception', 'Post-abortion Family Planning', 'mHealth']}, 'referencesModule': {'references': [{'pmid': '26668436', 'type': 'RESULT', 'citation': 'Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, Machiyama K, Slaymaker E, Warnock R, McCarthy O, Free C. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015 Dec 1;93(12):842-50A. doi: 10.2471/BLT.15.160267. Epub 2015 Oct 15.'}, {'pmid': '32130166', 'type': 'DERIVED', 'citation': 'Hill J, McGinn J, Cairns J, Free C, Smith C. A Mobile Phone-Based Support Intervention to Increase Use of Postabortion Family Planning in Cambodia: Cost-Effectiveness Evaluation. JMIR Mhealth Uhealth. 2020 Feb 25;8(2):e16276. doi: 10.2196/16276.'}, {'pmid': '29544520', 'type': 'DERIVED', 'citation': 'Smith C, Edwards P, Free C. Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Reprod Health. 2018 Mar 15;15(1):50. doi: 10.1186/s12978-018-0494-7.'}, {'pmid': '29191231', 'type': 'DERIVED', 'citation': 'Smith C, Jarvis C, Free C. Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Trials. 2017 Dec 1;18(1):577. doi: 10.1186/s13063-017-2316-6.'}, {'pmid': '25388660', 'type': 'DERIVED', 'citation': 'Smith C, Ngo TD, Edwards P, Free C. MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. Trials. 2014 Nov 12;15:440. doi: 10.1186/1745-6215-15-440.'}, {'pmid': '24330763', 'type': 'DERIVED', 'citation': 'Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Khut K, Edwards P, Rathavy T, Free C. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. Trials. 2013 Dec 12;14:427. doi: 10.1186/1745-6215-14-427.'}]}, 'descriptionModule': {'briefSummary': 'An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia.\n\nThe study seeks to address the research question: does a PAFP mHealth intervention increase use of contraception in Cambodia? STUDY RESULTS: http://www.who.int/bulletin/online\\_first/en/'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Client attending for abortion\n* Client does not want to have a child at the current time\n* Client aged 18 or over\n* Client owns a mobile phone\n* Client willing to receive simple voice messages relating to contraception from Marie Stopes in Khmer language\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria\n* Declined to participate'}, 'identificationModule': {'nctId': 'NCT01823861', 'acronym': 'MOTIF', 'briefTitle': 'Mobile Technology for Improved Family Planning', 'organization': {'class': 'OTHER', 'fullName': 'Marie Stopes International'}, 'orgStudyIdInfo': {'id': 'MarieStopes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile phone-based intervention', 'description': 'Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.', 'interventionNames': ['Behavioral: Mobile phone-based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': "Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number."}], 'interventions': [{'name': 'Mobile phone-based intervention', 'type': 'BEHAVIORAL', 'description': 'Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.', 'armGroupLabels': ['Mobile phone-based intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Marie Stopes International', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marie Stopes International', 'class': 'OTHER'}, 'collaborators': [{'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}