Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:35 PM
Study NCT ID:
NCT07430033
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Online-Based "Pregnant Women Care Cadres" Intervention on Husband Support in Early Detection of High Risk in Medan Maimun Area
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from Baseline in Husbands' Emotional, Informational, and Practical Support Score for Early Detection of High-Risk Pregnancy After 4 Weeks of Online-Based Intervention", 'timeFrame': 'From enrollment (baseline/pre-test) to the end of the online-based intervention at 4 weeks (post-test).', 'description': 'This outcome measures changes in husbands\' emotional, informational, and practical support for early detection of high-risk pregnancy following a 4-week online-based "Caring for Pregnant Women" intervention delivered by trained health cadres. Husbands\' support was assessed using a Family Support Questionnaire developed based on Friedman\'s Family Support Theory and high-risk pregnancy concepts. The questionnaire consists of 19 valid items covering emotional, informational, and practical support. Emotional, informational, and practical support were assessed separately, each with scores ranging from 10 to 50. Higher scores indicate greater support from husbands/families. The instrument showed good reliability (Cronbach\'s alpha = 0.879). The primary outcome was calculated as the difference between baseline (pre-intervention) and post-intervention scores at 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The goal of this quasi-experimental study is to evaluate whether an online-based "Caring for Pregnant Women" intervention delivered through community health cadres can improve husband support in the early detection of high-risk pregnancies among pregnant women and their husbands in the Medan Maimun area.\n\nThe main questions it aims to answer are:\n\nDoes the online-based "Caring for Pregnant Women" intervention increase emotional support from husbands in the early detection of high-risk pregnancies?\n\nDoes the intervention increase informational support from husbands in the early detection of high-risk pregnancies?\n\nDoes the intervention increase practical support from husbands in the early detection of high-risk pregnancies?\n\nThis study does not include a comparison group.\n\nParticipants will:\n\nComplete a pre-test questionnaire assessing emotional, informational, and practical support from husbands in the early detection of high-risk pregnancies\n\nParticipate in an online-based education program facilitated by trained health cadres for one month\n\nJoin a WhatsApp group involving husbands, pregnant women, and health cadres for education, monitoring, and communication related to high-risk pregnancy detection\n\nComplete a post-test questionnaire after the intervention to measure changes in husband support'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who lived with their families (husband/wife/children/inlaws)\n* Women who were able to communicate verbally\n* Registered in the Medan Maimun area with a Medan Maimun identity card\n* Registered with the neighborhood association\n* Had a health cadre responsible for the local area\n\nExclusion Criteria:\n\n* Pregnant women living alone\n* Unable to communicate verbally\n* Not registered in Medan Maimun\n* Without a Medan Maimun identity card\n* Not registered with the neighborhood association\n* Without an assigned health cadre'}, 'identificationModule': {'nctId': 'NCT07430033', 'briefTitle': 'Effectiveness of Online-Based "Pregnant Women Care Cadres" Intervention on Husband Support in Early Detection of High Risk in Medan Maimun Area', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sumatera Utara'}, 'officialTitle': 'Effectiveness of Online-Based "Pregnant Women Care Cadres" Intervention on Husband Support in Early Detection of High Risk in Medan Maimun Area', 'orgStudyIdInfo': {'id': 'No:22/KEPK/USU/2024'}, 'secondaryIdInfos': [{'id': '2837/UN5.1.R/SK/PPM/2023', 'type': 'OTHER_GRANT', 'domain': 'Talenta Universitas of Sumatera Utara 2837/UN5.1.R/SK/PPM/2023'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant Women Care Cadres Intervention', 'interventionNames': ['Behavioral: Online-Based "Caring for Pregnant Women" Intervention Through Community Health Cadres to Enhance Husband Support in Early Detection of High-Risk Pregnancy']}], 'interventions': [{'name': 'Online-Based "Caring for Pregnant Women" Intervention Through Community Health Cadres to Enhance Husband Support in Early Detection of High-Risk Pregnancy', 'type': 'BEHAVIORAL', 'description': 'The intervention consisted of an online-based educational program delivered by trained community health cadres. Education was provided through WhatsApp groups once per week for four consecutive weeks, including information on early detection of high-risk pregnancy and husband support.', 'armGroupLabels': ['Pregnant Women Care Cadres Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medan', 'country': 'Indonesia', 'facility': 'Universitas Sumatera Utara', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siti Saidah Nasution', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitas Sumatera Utara', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice Dean Faculty of Nursing', 'investigatorFullName': 'Siti Saidah Nasution', 'investigatorAffiliation': 'Universitas Sumatera Utara'}}}}