Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:27 AM
Study NCT ID:
NCT07457957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 874}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Score', 'timeFrame': '6 months after enrollment', 'description': 'Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Menstrual bleeding related quality of life', 'timeFrame': '6, 12, 24 months after enrollment', 'description': 'The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (\\<18) or adult version of the questionnaire will be used as appropriate.'}, {'measure': 'Knowledge about menstrual health', 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.'}, {'measure': 'School-, work-, and leisure absences', 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app.'}, {'measure': 'Societal costs', 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ).'}, {'measure': 'Quality of Life for cost-effectiveness calculation', 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'To calculate the cost-effectiveness of the intervention, the quality of life assessed with the 5-level EQ-5D (EQ-5D-5L) and EQ-5D-Y-5L as appropriate as a measure for effectiveness.'}, {'measure': "Participants' experience of effectiveness", 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change.'}, {'measure': 'Dose of mobile menstrual tracking and education application', 'timeFrame': '6, 12 and 24 months', 'description': 'Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received.'}, {'measure': 'Menstrual disturbance', 'timeFrame': '6, 12 and 24 months after enrollment', 'description': 'The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['randomized clinical trial', 'mHealth', 'Menstrual health', 'Adolescent', 'Menstrual Tracker App'], 'conditions': ['Dysmenorrhea', 'Heavy Menstrual Bleeding', 'Menstrual Cramps', 'Menstrual Bleeding, Heavy', 'Menstrual Discomfort', 'Menstrual Cycle Abnormal', 'Menstrual Disorder', 'Menstrual Health', 'Mobile Application', 'mHealth', 'Menstrual Health Intervention', 'Adolescent']}, 'referencesModule': {'references': [{'pmid': '38104798', 'type': 'BACKGROUND', 'citation': 'Ozcan H, Burger NB, Dulmen-den Broeder EV, van Baal MW, den Boogaard EV, De Leeuw RA, Huirne JAF. Instruments to Identify Menstrual Complaints and Their Impact on Adolescents: A Systematic Review. J Pediatr Adolesc Gynecol. 2024 Apr;37(2):106-120. doi: 10.1016/j.jpag.2023.11.011. Epub 2023 Dec 16.'}, {'pmid': '38437753', 'type': 'BACKGROUND', 'citation': 'Ozcan H, Burger NB, Derksen ME, Peute LW, Huirne JAF, De Leeuw RA. The differences between adults and adolescents using a mobile health application for menstrual complaints: A usability and qualitative study. Int J Med Inform. 2024 May;185:105382. doi: 10.1016/j.ijmedinf.2024.105382. Epub 2024 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.', 'detailedDescription': "Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.\n\nPostmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (\\<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score \\<3 or ≥3).\n\nParticipants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.\n\nThe primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.\n\nAll outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dutch, English, Turkish or Moroccan-Arabic speaking\n* Post menarche\n* Access to a smartphone or tablet with iOS or Android operating system\n\nExclusion Criteria:\n\n* Amenorrhea\n* Pregnancy\n* No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.\n* Previously or currently under treatment by a health care provider for menstrual complaints'}, 'identificationModule': {'nctId': 'NCT07457957', 'acronym': 'MGA', 'briefTitle': 'Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'MGA-studie'}, 'secondaryIdInfos': [{'id': '10390032310035', 'type': 'OTHER_GRANT', 'domain': 'ZonMw'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'App group', 'description': "Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application.", 'interventionNames': ['Other: Menstrual Tracker and Education Application']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist group', 'description': "Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired."}], 'interventions': [{'name': 'Menstrual Tracker and Education Application', 'type': 'OTHER', 'description': "The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.", 'armGroupLabels': ['App group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'contacts': [{'name': 'Esther Domenie', 'role': 'CONTACT', 'email': 'MGA-studie@amsterdamumc.nl', 'phone': '+31 6 23997219'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Esther Domenie, MSc', 'role': 'CONTACT', 'email': 'MGA-studie@amsterdamumc.nl', 'phone': '+31 6 23997219'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD. Principal Investigator', 'investigatorFullName': 'Dr. Robert A. de Leeuw', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}