Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 5:56 AM
Study NCT ID:
NCT04674059
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Descriptive Study on Patients With Bipolar Disorder in Rwanda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnoses', 'timeFrame': '1 year', 'description': 'Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.'}, {'measure': 'Diagnostic delay', 'timeFrame': '1 year', 'description': 'Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.'}, {'measure': 'Number of previous psychiatric hospitalisations', 'timeFrame': '1 year', 'description': 'Numerical value of the previous psychiatric hospitalisations.'}, {'measure': 'Number of previous crises', 'timeFrame': '1 year', 'description': 'Numerical value of the previous crises defined as an episode of depression or mania or hypomania.'}, {'measure': 'Types of medical treatment provided', 'timeFrame': '1 year', 'description': 'What type of medical treatment is provided, including brand name, administration and dosage.'}, {'measure': 'Medical Adherence', 'timeFrame': '1 year', 'description': 'Medication Adherence Rating Scale (MARS) will be used to assess beliefs and barriers to medication adherence. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.'}, {'measure': 'The referral pathways', 'timeFrame': '1 year', 'description': 'Who initiated the first contact, who did you seek for help, what kind of help was provided, percent of patients who came in contact with traditional leaders.'}, {'measure': 'Degree of internal stigma', 'timeFrame': '1 year', 'description': 'Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) will be used to assess self-stigma. The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Disorder', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda', 'detailedDescription': 'The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda for patients with bipolar disorder.\n\nKnowing about the barriers to treatment, risk and protective factors as well as the current treatment offered for patients with bipolar disorder is essential for the development of therapeutic approaches and improvement in access to care. Up to now, no data on characteristics of patients with bipolar disorder in Rwanda and related risk and protective factors is available. For this purpose, all outpatients with bipolar disorder in Rwanda age \\> 18 years, will over a 1-year period be invited to participate in a survey on their experience living with bipolar disorder in Rwanda. Moreover, patients and relatives will be invited for in-depth interviews to explore their perceptions and experiences with the mental health system. Health care providers will meet for focus discussions on to assess the experience, knowledge and practice of caregiving for individuals with bipolar disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with bipolar disorder in Rwanda', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04674059', 'briefTitle': 'A Descriptive Study on Patients With Bipolar Disorder in Rwanda', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Descriptive Study on Patients With Bipolar Disorder in Rwanda', 'orgStudyIdInfo': {'id': 'AUUR2020DKRW_3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'patient survey', 'type': 'OTHER', 'description': "A questionnaire will be delivered by the health care providers at Ndera Hospital, Kigali, Rwanda or CHUK, Hospital, Kigali, Rwanda. The questions will explore the patient's clinical characteristics, the current treatment and their experience with the mental health care system."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caroline J Arnbjerg, Msc', 'role': 'CONTACT', 'email': 'caroline.arnbjerg@ph.au.dk', 'phone': '+250786917224'}, {'name': 'Emmanuel Musoni Rwililiza, Msc', 'role': 'CONTACT', 'email': 'rwimus@gmail.com', 'phone': '+250788568244'}], 'overallOfficials': [{'name': 'Per Kallestrup, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rwanda', 'class': 'OTHER'}, {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}