Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT03245593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode.', 'timeFrame': '12 months', 'description': 'Clinician Rating Scale (1-7)'}], 'secondaryOutcomes': [{'measure': 'Study the clinician-reported difference between the 2 groups in medication adherence', 'timeFrame': '3 months', 'description': 'Clinician Rating Scale (1-7)'}, {'measure': 'Study the clinician-reported difference between the 2 groups in medication adherence', 'timeFrame': '6 months', 'description': 'Clinician Rating Scale (1-7)'}, {'measure': 'Study the clinician-reported difference between the 2 groups in medication adherence', 'timeFrame': '9 months', 'description': 'Clinician Rating Scale (1-7)'}, {'measure': 'Study the self-reported difference between the 2 groups in medication adherence', 'timeFrame': '3 months', 'description': 'Medication Adherence Rating Scale( 0-10),'}, {'measure': 'Study the self-reported difference between the 2 groups in medication adherence', 'timeFrame': '6 months', 'description': 'Medication Adherence Rating Scale( 0-10),'}, {'measure': 'Study the self-reported difference between the 2 groups in medication adherence', 'timeFrame': '9 months', 'description': 'Medication Adherence Rating Scale( 0-10),'}, {'measure': 'Study the self-reported difference between the 2 groups in medication adherence', 'timeFrame': '12 months', 'description': 'Medication Adherence Rating Scale( 0-10),'}, {'measure': 'Clinical evaluation of the difference between the 2 groups in medication adherence', 'timeFrame': '3 months', 'description': 'Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants'}, {'measure': 'Clinical evaluation of the difference between the 2 groups in medication adherence', 'timeFrame': '6 months', 'description': 'Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants'}, {'measure': 'Clinical evaluation of the difference between the 2 groups in medication adherence', 'timeFrame': '9 months', 'description': 'Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants'}, {'measure': 'Clinical evaluation of the difference between the 2 groups in medication adherence', 'timeFrame': '12 months', 'description': 'Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants'}, {'measure': 'Compare difference in the adherence to personalized follow-up between groups', 'timeFrame': '3 months', 'description': 'percentage of consultations missed'}, {'measure': 'Compare difference in the adherence to personalized follow-up between groups', 'timeFrame': '6 months', 'description': 'percentage of consultations missed'}, {'measure': 'Compare difference in the adherence to personalized follow-up between groups', 'timeFrame': '9 months', 'description': 'percentage of consultations missed'}, {'measure': 'Compare difference in the adherence to personalized follow-up between groups', 'timeFrame': '12 months', 'description': 'percentage of consultations missed'}, {'measure': 'Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '3 months', 'description': 'decisional conflict scale (0-100)'}, {'measure': 'Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '6 months', 'description': 'decisional conflict scale (0-100)'}, {'measure': 'Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '9 months', 'description': 'decisional conflict scale (0-100)'}, {'measure': 'Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '12 months', 'description': 'decisional conflict scale (0-100)'}, {'measure': 'Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '3 months', 'description': 'adapted QSH-45: 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '6 months', 'description': 'adapted QSH-45: 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '9 months', 'description': 'adapted QSH-45: 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '12 months', 'description': 'adapted QSH-45: 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the decision-making process between groups', 'timeFrame': '3 months', 'description': 'Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the decision-making process between groups', 'timeFrame': '6 months', 'description': 'Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the decision-making process between groups', 'timeFrame': '9 months', 'description': 'Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5'}, {'measure': 'Compare difference in patient satisfaction concerning the decision-making process between groups', 'timeFrame': '12 months', 'description': 'Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5'}, {'measure': 'Compare difference in therapeutic alliance between groups', 'timeFrame': '3 months', 'description': '4-Point ordinal Alliance Scale'}, {'measure': 'Compare difference in therapeutic alliance between groups', 'timeFrame': '6 months', 'description': '4-Point ordinal Alliance Scale'}, {'measure': 'Compare difference in therapeutic alliance between groups', 'timeFrame': '9 months', 'description': '4-Point ordinal Alliance Scale'}, {'measure': 'Compare difference in therapeutic alliance between groups', 'timeFrame': '12 months', 'description': '4-Point ordinal Alliance Scale'}, {'measure': 'Compare difference in knowledge of disease and treatment necessary to making decisions between groups', 'timeFrame': '3 months', 'description': 'Knowledge questionnaire: % correct answers'}, {'measure': 'Compare difference in knowledge of disease and treatment necessary to making decisions between groups', 'timeFrame': '6 months', 'description': 'Knowledge questionnaire: % correct answers'}, {'measure': 'Compare difference in knowledge of disease and treatment necessary to making decisions between groups', 'timeFrame': '9 months', 'description': 'Knowledge questionnaire: % correct answers'}, {'measure': 'Compare difference in knowledge of disease and treatment necessary to making decisions between groups', 'timeFrame': '12 months', 'description': 'Knowledge questionnaire: % correct answers'}, {'measure': 'Compare difference in patient attitude towards the treatment between groups', 'timeFrame': '3 months', 'description': 'Beliefs about Medicines Questionnaire: 18 questions 1-5'}, {'measure': 'Compare difference in patient attitude towards the treatment between groups', 'timeFrame': '6 months', 'description': 'Beliefs about Medicines Questionnaire: 18 questions 1-5'}, {'measure': 'Compare difference in patient attitude towards the treatment between groups', 'timeFrame': '9 months', 'description': 'Beliefs about Medicines Questionnaire: 18 questions 1-5'}, {'measure': 'Compare difference in patient attitude towards the treatment between groups', 'timeFrame': '12 months', 'description': 'Beliefs about Medicines Questionnaire: 18 questions 1-5'}, {'measure': 'Compare number and duration of mood episodes between groups months', 'timeFrame': '3 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of mood episodes between groups months', 'timeFrame': '6 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of mood episodes between groups months', 'timeFrame': '9 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of mood episodes between groups months', 'timeFrame': '12 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of hospitalizations in psychiatric service between groups', 'timeFrame': '3 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of hospitalizations in psychiatric service between groups', 'timeFrame': '6 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of hospitalizations in psychiatric service between groups', 'timeFrame': '9 months', 'description': 'number of events; number of days'}, {'measure': 'Compare number and duration of hospitalizations in psychiatric service between groups', 'timeFrame': '12 months', 'description': 'number of events; number of days'}, {'measure': 'Compare manic symptomatology during evaluations between groups', 'timeFrame': '3 months', 'description': 'Young Mania Rating Scale'}, {'measure': 'Compare manic symptomatology during evaluations between groups', 'timeFrame': '6 months', 'description': 'Young Mania Rating Scale'}, {'measure': 'Compare manic symptomatology during evaluations between groups', 'timeFrame': '9 months', 'description': 'Young Mania Rating Scale'}, {'measure': 'Compare manic symptomatology during evaluations between groups', 'timeFrame': '12 months', 'description': 'Young Mania Rating Scale'}, {'measure': 'Compare the depressive symptomatology during evaluations between groups', 'timeFrame': '3 months', 'description': 'Montgomery-Asberg Depression Rating Scale'}, {'measure': 'Compare the depressive symptomatology during evaluations between groups', 'timeFrame': '6 months', 'description': 'Montgomery-Asberg Depression Rating Scale'}, {'measure': 'Compare the depressive symptomatology during evaluations between groups', 'timeFrame': '9 months', 'description': 'Montgomery-Asberg Depression Rating Scale'}, {'measure': 'Compare the depressive symptomatology during evaluations between groups', 'timeFrame': '12 months', 'description': 'Montgomery-Asberg Depression Rating Scale'}, {'measure': 'Compare severity and intensity of suicidal ideas between groups', 'timeFrame': '3 months', 'description': 'Columbia-Suicide Severity Rating Scale'}, {'measure': 'Compare severity and intensity of suicidal ideas between groups', 'timeFrame': '6 months', 'description': 'Columbia-Suicide Severity Rating Scale'}, {'measure': 'Compare severity and intensity of suicidal ideas between groups', 'timeFrame': '9 months', 'description': 'Columbia-Suicide Severity Rating Scale'}, {'measure': 'Compare severity and intensity of suicidal ideas between groups', 'timeFrame': '12 months', 'description': 'Columbia-Suicide Severity Rating Scale'}, {'measure': 'Compare the psychosocial functioning between groups', 'timeFrame': '3 months', 'description': 'Functioning Assessment Short Test (0-72)'}, {'measure': 'Compare the psychosocial functioning between groups', 'timeFrame': '6 months', 'description': 'Functioning Assessment Short Test (0-72)'}, {'measure': 'Compare the psychosocial functioning between groups', 'timeFrame': '9 months', 'description': 'Functioning Assessment Short Test (0-72)'}, {'measure': 'Compare the psychosocial functioning between groups', 'timeFrame': '12 months', 'description': 'Functioning Assessment Short Test (0-72)'}, {'measure': 'Compare quality of life between groups', 'timeFrame': '3 months', 'description': 'WHOQOL-BREF (0-100)'}, {'measure': 'Compare quality of life between groups', 'timeFrame': '6 months', 'description': 'WHOQOL-BREF (0-100)'}, {'measure': 'Compare quality of life between groups', 'timeFrame': '9 months', 'description': 'WHOQOL-BREF (0-100)'}, {'measure': 'Compare quality of life between groups', 'timeFrame': '12 months', 'description': 'WHOQOL-BREF (0-100)'}, {'measure': 'Compare length of consultations between groups', 'timeFrame': 'every consultation for 12 months', 'description': 'minutes'}, {'measure': 'Clinician satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '3 months', 'description': 'adapted QSH-45 doctor version 3 questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '6 months', 'description': 'adapted QSH-45 doctor version 3 questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '9 months', 'description': 'adapted QSH-45 doctor version 3 questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the therapeutic decisions taken between groups', 'timeFrame': '12 months', 'description': 'adapted QSH-45 doctor version 3 questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the decision-making process between groups', 'timeFrame': '3 months', 'description': 'Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the decision-making process between groups', 'timeFrame': '6 months', 'description': 'Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the decision-making process between groups', 'timeFrame': '9 months', 'description': 'Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5'}, {'measure': 'Clinician satisfaction concerning the decision-making process between groups', 'timeFrame': '12 months', 'description': 'Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5'}, {'measure': 'Clinician perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '3 months', 'description': 'decisional conflict scale doctor version (0-100)'}, {'measure': 'Clinician perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '6 months', 'description': 'decisional conflict scale doctor version (0-100)'}, {'measure': 'Clinician perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '9 months', 'description': 'decisional conflict scale doctor version (0-100)'}, {'measure': 'Clinician perceptions related to the uncertainty of the medical decisions taken between groups', 'timeFrame': '12 months', 'description': 'decisional conflict scale doctor version (0-100)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '29653535', 'type': 'DERIVED', 'citation': 'Samalin L, Honciuc M, Boyer L, de Chazeron I, Blanc O, Abbar M, Llorca PM. Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD). BMC Psychiatry. 2018 Apr 13;18(1):103. doi: 10.1186/s12888-018-1686-y.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient must be available for the 12 months of follow-up\n* The patient is at least 18 years old\n* Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria\n* Following resolution of a mood episode (manic or depressive according to DSM-5 criteria) according to the criteria of l'International Society for Bipolar Disorder (Recovery, clinical remission of at least 4 weeks)\n* Followed by at least one of the practitioner belonging to one of the participating centers\n* Without comprehension problems of fluent French\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months\n* The subject is in a period of exclusion determined by a previous study\n* The patient is under safeguard of justice or state guardianship\n* It is impossible to give the subject informed information, or the subject refuses to sign the consent\n* The subject has already participated in this study\n* The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5)\n* The patient has a revision of the initial diagnosis of bipolar disorder"}, 'identificationModule': {'nctId': 'NCT03245593', 'acronym': 'ShareD-BD', 'briefTitle': 'Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder', 'orgStudyIdInfo': {'id': 'PREPS/2016/LS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shared Decision making for care', 'interventionNames': ['Other: Shared-decision making process']}, {'type': 'OTHER', 'label': 'Standard decision making for care', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'Shared-decision making process', 'type': 'OTHER', 'description': 'Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available', 'armGroupLabels': ['Shared Decision making for care']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'Care of patients according to standard practice of managing patients with bipolar disorder', 'armGroupLabels': ['Standard decision making for care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Béziers', 'country': 'France', 'facility': 'Ch Beziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CH Charles Perrens', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69678', 'city': 'Bron', 'country': 'France', 'facility': 'CH le Vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont Ferrand - Hôpital Gabriel-Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Chu Gabriel Montpied Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63037', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CH Sainte-Marie de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'APHP - Centre Hospitalier Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hôpital Albert Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '87025', 'city': 'Limoges', 'country': 'France', 'facility': 'CH Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital Sainte-Marguerite', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'Clinique des troubles thymiques', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Ludovic Samalin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}