Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

N/AActive Not RecruitingNCT03245593

Centre Hospitalier Universitaire de Nīmes300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Bipolar Disorder

Interventions

Shared-decision making processOTHER

Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available

standard careOTHER

Care of patients according to standard practice of managing patients with bipolar disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (16)

Ch Beziers

Béziers, France

CH Charles Perrens

Bordeaux, France

CH le Vinatier

Bron, France

Outcomes

Primary Outcomes

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.

Clinician Rating Scale (1-7)

Time frame: 12 months

Secondary Outcomes

Study the clinician-reported difference between the 2 groups in medication adherence

Clinician Rating Scale (1-7)

Time frame: 3 months

Study the clinician-reported difference between the 2 groups in medication adherence

Clinician Rating Scale (1-7)

Time frame: 6 months

Study the clinician-reported difference between the 2 groups in medication adherence

Clinician Rating Scale (1-7)

Time frame: 9 months

Study the self-reported difference between the 2 groups in medication adherence

Medication Adherence Rating Scale( 0-10),

Time frame: 3 months

Study the self-reported difference between the 2 groups in medication adherence

Medication Adherence Rating Scale( 0-10),

Time frame: 6 months

Study the self-reported difference between the 2 groups in medication adherence

Medication Adherence Rating Scale( 0-10),

Time frame: 9 months

Study the self-reported difference between the 2 groups in medication adherence

Data from ClinicalTrials.gov

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CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, France

Chu Gabriel Montpied Clermont Ferrand

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

...and 6 more locations

Medication Adherence Rating Scale( 0-10),

Time frame: 12 months

Clinical evaluation of the difference between the 2 groups in medication adherence

Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

Time frame: 3 months

Clinical evaluation of the difference between the 2 groups in medication adherence

Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

Time frame: 6 months

Clinical evaluation of the difference between the 2 groups in medication adherence

Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

Time frame: 9 months

Clinical evaluation of the difference between the 2 groups in medication adherence

Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants

Time frame: 12 months

Compare difference in the adherence to personalized follow-up between groups

percentage of consultations missed

Time frame: 3 months

Compare difference in the adherence to personalized follow-up between groups

percentage of consultations missed

Time frame: 6 months

Compare difference in the adherence to personalized follow-up between groups

percentage of consultations missed

Time frame: 9 months

Compare difference in the adherence to personalized follow-up between groups

percentage of consultations missed

Time frame: 12 months

Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

decisional conflict scale (0-100)

Time frame: 3 months

Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

decisional conflict scale (0-100)

Time frame: 6 months

Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

decisional conflict scale (0-100)

Time frame: 9 months

Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups

decisional conflict scale (0-100)

Time frame: 12 months

Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

adapted QSH-45: 3 questions scored 1-5

Time frame: 3 months

Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

adapted QSH-45: 3 questions scored 1-5

Time frame: 6 months

Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

adapted QSH-45: 3 questions scored 1-5

Time frame: 9 months

Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups

adapted QSH-45: 3 questions scored 1-5

Time frame: 12 months

Compare difference in patient satisfaction concerning the decision-making process between groups

Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

Time frame: 3 months

Compare difference in patient satisfaction concerning the decision-making process between groups

Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

Time frame: 6 months

Compare difference in patient satisfaction concerning the decision-making process between groups

Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

Time frame: 9 months

Compare difference in patient satisfaction concerning the decision-making process between groups

Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5

Time frame: 12 months

Compare difference in therapeutic alliance between groups

4-Point ordinal Alliance Scale

Time frame: 3 months

Compare difference in therapeutic alliance between groups

4-Point ordinal Alliance Scale

Time frame: 6 months

Compare difference in therapeutic alliance between groups

4-Point ordinal Alliance Scale

Time frame: 9 months

Compare difference in therapeutic alliance between groups

4-Point ordinal Alliance Scale

Time frame: 12 months

Compare difference in knowledge of disease and treatment necessary to making decisions between groups

Knowledge questionnaire: % correct answers

Time frame: 3 months

Compare difference in knowledge of disease and treatment necessary to making decisions between groups

Knowledge questionnaire: % correct answers

Time frame: 6 months

Compare difference in knowledge of disease and treatment necessary to making decisions between groups

Knowledge questionnaire: % correct answers

Time frame: 9 months

Compare difference in knowledge of disease and treatment necessary to making decisions between groups

Knowledge questionnaire: % correct answers

Time frame: 12 months

Compare difference in patient attitude towards the treatment between groups

Beliefs about Medicines Questionnaire: 18 questions 1-5

Time frame: 3 months

Compare difference in patient attitude towards the treatment between groups

Beliefs about Medicines Questionnaire: 18 questions 1-5

Time frame: 6 months

Compare difference in patient attitude towards the treatment between groups

Beliefs about Medicines Questionnaire: 18 questions 1-5

Time frame: 9 months

Compare difference in patient attitude towards the treatment between groups

Beliefs about Medicines Questionnaire: 18 questions 1-5

Time frame: 12 months

Compare number and duration of mood episodes between groups months