Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-31 @ 12:26 AM
Study NCT ID:
NCT05666050
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Intervention to Improve Neonatal Care Practice
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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessors will be masked about which group is intervention and control to avoid bias.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 784}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score).', 'timeFrame': 'Two weeks after intervention the outcome will be measured.', 'description': 'Principal component analysis will be done to create composite index (score) and respondents who will have scored above or equal to the mean/median value will be considered as having good neonatal care, while those who will score below the mean/median value were considered as poor neonatal care.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal care, Dessie, Kombolcha, Ethiopia'], 'conditions': ['Neonatal Care']}, 'referencesModule': {'references': [{'pmid': '34754945', 'type': 'BACKGROUND', 'citation': 'Cherie N, Abdulkerim M, Abegaz Z, Walle Baze G. Maternity continuum of care and its determinants among mothers who gave birth in Legambo district, South Wollo, northeast Ethiopia. Health Sci Rep. 2021 Nov 2;4(4):e409. doi: 10.1002/hsr2.409. eCollection 2021 Dec.'}, {'pmid': '39789852', 'type': 'DERIVED', 'citation': 'Cherie N, Wordofa MA, Debelew GT. The effect of an interactive mobile health intervention to improve community-based essential neonatal care practices among postpartum women in northeast Ethiopia: a cluster randomized controlled trial. Int Health. 2025 Sep 3;17(5):820-835. doi: 10.1093/inthealth/ihae080.'}]}, 'descriptionModule': {'briefSummary': 'Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.', 'detailedDescription': 'The main aim of this study is to determine effectiveness of mobile health intervention to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new intervention with existed health care practice and the control arm will take the existed current health care practice.\n\nThe intervention arm will receive sending message service (SMS) over a four month period (90 days pre-natal and 42 days post-partum) and the control arm will receive the existed health care practice. Participants in the intervention arm will receive mobile based health education and health communication messages as well as messages on neonatal care practice based on national maternal and child health care education and counseling guidelines. Participants in this study will be randomly assigned as intervention will receive sending message service from a trained professional; while participants assigned to control group will not receive phone based interventions but can contact their health care providers as routine health facility activity. Initially, study participants will receive one text message every two weeks with the frequency increasing to messages for 42 days following delivery.\n\nPregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post par-tum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.\n\nExclusion Criteria:\n\n* Pregnant women seriously ill and not able to respond.'}, 'identificationModule': {'nctId': 'NCT05666050', 'acronym': 'NCP', 'briefTitle': 'Mobile Health Intervention to Improve Neonatal Care Practice', 'organization': {'class': 'OTHER', 'fullName': 'Wollo University'}, 'officialTitle': 'Effectiveness of Interactive Mobile Health Intervention (IMHI) to Improve Neonatal Care Practice Among Postpartum Women in Dessie and Kombolcha Town Zones, North East Ethiopia: Behavioral Cluster Randomized Control Trial', 'orgStudyIdInfo': {'id': 'JUIH/IRB/230/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will receive mobile health intervention sending message service(SMS)', 'interventionNames': ['Behavioral: Mobile health intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive the existed current health delivery approach, no mobile health sending message service'}], 'interventions': [{'name': 'Mobile health intervention', 'type': 'BEHAVIORAL', 'description': 'Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and will be continued up to 6 weeks of post partum period for 4 months.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1145', 'city': 'Dessie', 'state': 'South Wollo', 'country': 'Ethiopia', 'facility': 'Dessie and Kombolcha', 'geoPoint': {'lat': 11.13333, 'lon': 39.63333}}], 'overallOfficials': [{'name': 'Niguss Cherie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wollo Universirty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data from the participants will be confidential.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wollo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jimma University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Niguss Cherie', 'investigatorAffiliation': 'Wollo University'}}}}