Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04208867
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality Improvement Project for Reproductive Health Services in India, Phase 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2989}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-19', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': 'Baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': '2-weeks post basline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': '4 weeks post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': '10 weeks post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': 'About 12 months post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': 'About 14 months post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': 'about 24 months after baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': 'About 24.5 months post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': '25 months post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Maternal Health Scale Score', 'timeFrame': '26.5 months past baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-100; higher the score the better the experience of care'}, {'measure': 'Person Centered Family Planning Scale Score', 'timeFrame': 'Baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care'}, {'measure': 'Person Centered Family Planning Scale Score', 'timeFrame': '4 weeks post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care'}, {'measure': 'Person Centered Family Planning Scale Score', 'timeFrame': '10 weeks post baseline', 'description': 'Survey conducted with women: self report of experiences of care. Possible range 0-43; higher the score the better the experience of care'}, {'measure': 'Attitude toward Person-Centered Care', 'timeFrame': 'About 12 months post baseline', 'description': 'Survey and in-depth interviews conducted with providers; perceptions of person-centered care'}, {'measure': 'Attitude toward Person-Centered Care', 'timeFrame': 'About 24 months post baseline', 'description': 'Survey and in-depth interviews conducted with providers; perceptions of person-centered care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maternal Health', 'Delivery', 'Person-centered Care', 'India', 'Family Planning'], 'conditions': ['Maternal Health', 'Delivery', 'Reproductive Health']}, 'referencesModule': {'references': [{'pmid': '33276773', 'type': 'DERIVED', 'citation': 'Montagu D, Giessler K, Nakphong MK, Green C, Roy KP, Sahu AB, Sharma K, Sudhinarset M. A comparison of intensive vs. light-touch quality improvement interventions for maternal health in Uttar Pradesh, India. BMC Health Serv Res. 2020 Dec 4;20(1):1121. doi: 10.1186/s12913-020-05960-6.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services.', 'detailedDescription': 'Evaluation of a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India aimed at improving person-centered care (PCC) for reproductive health (RH) services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Women:\n\n* Women aged 18-49\n* Agree/consent to participate\n* Delivered a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))\n\nExclusion Criteria for Women:\n\n* Not a women aged 18-49\n* Did not agree/consent to participate\n* Did not deliver a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))\n\nInclusion Criteria for Providers:\n\n* Agreed/consented to participate\n* Staff at facility\n\nExclusion Criteria for Provider:\n\n* Did not agree/consent to participate\n* Not Staff at facility'}, 'identificationModule': {'nctId': 'NCT04208867', 'acronym': 'SPARQ_QII1', 'briefTitle': 'Quality Improvement Project for Reproductive Health Services in India, Phase 1', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Strengthening People-centered Accessibility, Respect, and Quality for Reproductive Health Services in Uttar Pradesh, India, Phase 1', 'orgStudyIdInfo': {'id': '15-18008_IndiaQI1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - Women', 'description': 'Women who receive MH services from a facility participating in the QI collaborative to improve PCC', 'interventionNames': ['Behavioral: QI Collaborative']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Women', 'description': 'Women who receive MH services from a facility not participating in the QI collaborative to improve PCC'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention - Provider', 'description': 'Provider working at a facility participating in the QI collaborative to improve PCC', 'interventionNames': ['Behavioral: QI Collaborative']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Provider', 'description': 'Provider working at a facility not participating in the QI collaborative to improve PCC'}], 'interventions': [{'name': 'QI Collaborative', 'type': 'BEHAVIORAL', 'description': 'Facilities that participated in a QI collaborative to improve PCC for MH services', 'armGroupLabels': ['Intervention - Provider', 'Intervention - Women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Population Services International', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'overallOfficials': [{'name': 'Dominic Montagu, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Services International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}