Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
- Conditions
- Bipolar Disorder
- Interventions
- Other: standard careOther: Shared-decision making process
- Registration Number
- NCT03245593
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient must be available for the 12 months of follow-up
- The patient is at least 18 years old
- Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria
- 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)
- Followed by at least one of the practitioner belonging to one of the participating centers
- Without comprehension problems of fluent French
- The subject is participating in an interventional study, or has participated in another interventional study within the previous 3 months
- The subject is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice or state guardianship
- It is impossible to give the subject informed information, or the subject refuses to sign the consent
- The subject has already participated in this study
- The patient has troubles linked to the usage of severe intensive substances (such as those defined by the DMS-5)
- The patient has a revision of the initial diagnosis of bipolar disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard decision making for care standard care - Shared Decision making for care Shared-decision making process -
- Primary Outcome Measures
Name Time Method 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. 12 months Clinician Rating Scale (1-7)
- Secondary Outcome Measures
Name Time Method Compare the depressive symptomatology during evaluations between groups 12 months Montgomery-Asberg Depression Rating Scale
Study the clinician-reported difference between the 2 groups in medication adherence 9 months Clinician Rating Scale (1-7)
Compare difference in therapeutic alliance between groups 12 months 4-Point ordinal Alliance Scale
Compare difference in knowledge of disease and treatment necessary to making decisions between groups 12 months Knowledge questionnaire: % correct answers
Clinician satisfaction concerning the decision-making process between groups 12 months Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
Study the self-reported difference between the 2 groups in medication adherence 12 months Medication Adherence Rating Scale( 0-10),
Clinical evaluation of the difference between the 2 groups in medication adherence 12 months Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
Compare difference in patient attitude towards the treatment between groups 12 months Beliefs about Medicines Questionnaire: 18 questions 1-5
Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups 12 months adapted QSH-45: 3 questions scored 1-5
Compare difference in patient satisfaction concerning the decision-making process between groups 12 months Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
Compare severity and intensity of suicidal ideas between groups 12 months Columbia-Suicide Severity Rating Scale
Compare difference in the adherence to personalized follow-up between groups 12 months percentage of consultations missed
Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups 12 months decisional conflict scale (0-100)
Compare number and duration of mood episodes between groups months 12 months number of events; number of days
Compare manic symptomatology during evaluations between groups 12 months Young Mania Rating Scale
Compare number and duration of hospitalizations in psychiatric service between groups 12 months number of events; number of days
Compare quality of life between groups 12 months WHOQOL-BREF (0-100)
Clinician satisfaction concerning the therapeutic decisions taken between groups 12 months adapted QSH-45 doctor version 3 questions scored 1-5
Clinician perceptions related to the uncertainty of the medical decisions taken between groups 12 months decisional conflict scale doctor version (0-100)
Compare the psychosocial functioning between groups 12 months Functioning Assessment Short Test (0-72)
Compare length of consultations between groups every consultation for 12 months minutes
Trial Locations
- Locations (16)
Ch Beziers
🇫🇷Beziers, France
CH Charles Perrens
🇫🇷Bordeaux, France
CH le Vinatier
🇫🇷Bron, France
Chu Gabriel Montpied Clermont Ferrand
🇫🇷Clermont Ferrand, France
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
🇫🇷Clermont-Ferrand, France
CH Sainte-Marie de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
APHP - Centre Hospitalier Henri Mondor
🇫🇷Créteil, France
CHU de Grenoble - Hôpital Albert Michallon
🇫🇷Grenoble, France
CH Limoges
🇫🇷Limoges, France
APHM - Hôpital Sainte-Marguerite
🇫🇷Marseille, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France
CHU Nancy
🇫🇷Nancy, France
CHU Nantes
🇫🇷Nantes, France
Clinique des troubles thymiques
🇫🇷Nîmes, France
CHU Nimes
🇫🇷Nîmes, France
APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal
🇫🇷Paris, France