Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT04279093
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2020-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Assessment of Well-being in New Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-18', 'size': 541749, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-16T07:44', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 408067, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-14T06:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase'}, {'measure': 'Percentage of eligible individuals recruited to the study', 'timeFrame': 'Baseline', 'description': 'Percentage of eligible individuals recruited to the study'}, {'measure': 'Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Percentage of participants who consent to take part in the study dropping out during the app use phase'}, {'measure': 'Percentage of participants completing at least a third of app-based assessments', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Percentage of participants completing at least a third of app-based assessments. The a priori "accept" criterion will be \\>33% data points completed'}, {'measure': 'Percentage of participants completing at least half of app-based assessments', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Percentage of participants completing at least half of app-based assessments. The a priori target criterion will be 50% of participants submitting at least 50% of app-based assessments.'}], 'secondaryOutcomes': [{'measure': 'Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app', 'timeFrame': '6 weeks postpartum', 'description': 'Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app'}, {'measure': 'abridged Mobile App Rating Scale', 'timeFrame': '6 weeks postpartum', 'description': 'abridged Mobile App Rating Scale score'}, {'measure': 'Edinburgh Postnatal Depression Scale - app-based version', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Edinburgh Postnatal Depression Scale - app-based version'}, {'measure': 'Edinburgh Postnatal Depression Scale - paper version', 'timeFrame': '36-37 weeks gestation; 5-6 weeks postpartum', 'description': 'Edinburgh Postnatal Depression Scale - paper version'}, {'measure': 'Number of adverse events occurring during the app-use phase of the study', 'timeFrame': '36 weeks gestation until 6 weeks postpartum', 'description': 'Number of adverse events occurring during the app-use phase of the study'}, {'measure': "Qualitative interview data on participants' experience of using the app.", 'timeFrame': '6 weeks postpartum', 'description': "Qualitative interview data on participants' experience of using the app."}, {'measure': 'Demographic questionnaire', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': "Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status."}, {'measure': 'BMI (from casenotes)', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': 'BMI (from casenotes)'}, {'measure': 'past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': 'past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)'}, {'measure': 'Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': 'Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)'}, {'measure': 'Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': 'Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)'}, {'measure': 'parity (total number of pregnancies reaching viable gestational age)', 'timeFrame': 'Baseline (36 weeks pregnant)', 'description': 'parity (total number of pregnancies reaching viable gestational age)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital screening', 'mental health', 'smartphone app', 'postnatal depression', 'maternal mental health', 'paternal mental health'], 'conditions': ['Postnatal Depression']}, 'referencesModule': {'references': [{'pmid': '35606731', 'type': 'DERIVED', 'citation': 'Eisner E, Lewis S, Stockton-Powdrell C, Agass R, Whelan P, Tower C. Digital screening for postnatal depression: mixed methods proof-of-concept study. BMC Pregnancy Childbirth. 2022 May 23;22(1):429. doi: 10.1186/s12884-022-04756-2.'}]}, 'descriptionModule': {'briefSummary': "The mental health of new parents around the time of the birth of their baby has been identified as a key priority in the NHS (National Health Service) Long Term plan. At present, there is no nationally implemented method for monitoring parents' mental health, although the use of the Edinburgh Postnatal Depression Scale (EPDS) has been recommended. This is a paper based questionnaire administered by health visitors in the postnatal period. For the purposes of this project, the investigators contacted health visitors in Manchester to find out how they use EPDS in practice. Currently, health visitors only use the questionnaire if they feel there is a need during visits, and the questionnaire is not kept (only the overall score). Since almost 20% of mums develop postnatal depression, more systematic and thorough screening is needed.\n\nThe investigators developed an app version of the EPDS which takes less than 2 minutes to complete on a smartphone. It is anticpated that this will be a more accessible and practical method of conducting this important assessment. This project is a feasibility study to find out whether an app would be a feasible, acceptable, valid and safe way to monitor perinatal mental health in women and their partners.\n\nThe investigators aim to recruit 20 women and their partners in late pregnancy (after 36 weeks gestation) and ask them to use the app. The app will prompt completion of the EPDS once per day until 6 weeks postnatally. Participants' responses on the app will be transferred to a secure server at the University of Manchester. Participants will be invited to complete a paper version of the EPDS at the beginning and end of the study to check validity. They will also be asked to complete a questionnaire measuring the acceptability of the app and to take part in a brief qualitative interview at the end of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.", 'healthyVolunteers': True, 'eligibilityCriteria': "The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.\n\nInclusion criteria for pregnant women:\n\n* after 36 weeks gestation\n* aged over 18 years\n* fluent in English\n* under the care of Manchester University NHS Foundation Trust\n\nExclusion criteria for pregnant women:\n\n* current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)\n* fetal abnormality\n* multiple pregnancy\n\nInclusion criteria for partners:\n\n* male or female partners of a mum participating in the study\n* aged over 18\n* fluent in English."}, 'identificationModule': {'nctId': 'NCT04279093', 'acronym': 'DAWN-P', 'briefTitle': 'Digital Assessment of Well-being in New Parents', 'organization': {'class': 'OTHER', 'fullName': 'Manchester Academic Health Science Centre'}, 'officialTitle': 'Digital Assessment of Well-being in New Parents (DAWN-P)', 'orgStudyIdInfo': {'id': '274007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant/postpartum women and their partners', 'description': "The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital. Their partners will be invited to participate where applicable.\n\nInclusion and exclusion criteria for pregnant women are as follows:\n\n* Inclusion: after 36 weeks gestation, aged over 18 years and fluent in English, under the care of Manchester University NHS Foundation Trust\n* Exclusion: current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study), fetal abnormality, or multiple pregnancy\n\nInclusion criteria for partners: male or female partners of a mum participating in the study, aged over 18 and fluent in English.", 'interventionNames': ['Other: No intervention, but participants will use a smartphone app daily to complete the EPDS']}], 'interventions': [{'name': 'No intervention, but participants will use a smartphone app daily to complete the EPDS', 'type': 'OTHER', 'description': 'No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale', 'armGroupLabels': ['Pregnant/postpartum women and their partners']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing of data beyond the research team will be on a per request basis; only that data which can be fully anonymised data will be shared.Qualitative data or full demographics will not be shared due to potential identifiability.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emily Eisner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Emily Eisner', 'investigatorAffiliation': 'Manchester Academic Health Science Centre'}}}}