Clinical trial NCT03245593: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Official title: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopolar disorder in consultation at one of the recruiting centers

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


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Study the clinician-reported difference between the 2 groups in medication adherence
timeFrame: 3 months
measure: Study the clinician-reported difference between the 2 groups in medication adherence
timeFrame: 6 months
measure: Study the clinician-reported difference between the 2 groups in medication adherence
timeFrame: 9 months
measure: Study the self-reported difference between the 2 groups in medication adherence
timeFrame: 3 months
measure: Study the self-reported difference between the 2 groups in medication adherence
timeFrame: 6 months
measure: Study the self-reported difference between the 2 groups in medication adherence
timeFrame: 9 months
measure: Study the self-reported difference between the 2 groups in medication adherence
timeFrame: 12 months
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
timeFrame: 3 months
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
timeFrame: 6 months
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
timeFrame: 9 months
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
timeFrame: 12 months
measure: Compare difference in the adherence to personalized follow-up between groups
timeFrame: 3 months
measure: Compare difference in the adherence to personalized follow-up between groups
timeFrame: 6 months
measure: Compare difference in the adherence to personalized follow-up between groups
timeFrame: 9 months
measure: Compare difference in the adherence to personalized follow-up between groups
timeFrame: 12 months
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 3 months
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 6 months
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 9 months
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 12 months
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 3 months
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 6 months
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 9 months
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 12 months
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
timeFrame: 3 months
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
timeFrame: 6 months
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
timeFrame: 9 months
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
timeFrame: 12 months
measure: Compare difference in therapeutic alliance between groups
timeFrame: 3 months
measure: Compare difference in therapeutic alliance between groups
timeFrame: 6 months
measure: Compare difference in therapeutic alliance between groups
timeFrame: 9 months
measure: Compare difference in therapeutic alliance between groups
timeFrame: 12 months
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
timeFrame: 3 months
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
timeFrame: 6 months
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
timeFrame: 9 months
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
timeFrame: 12 months
measure: Compare difference in patient attitude towards the treatment between groups
timeFrame: 3 months
measure: Compare difference in patient attitude towards the treatment between groups
timeFrame: 6 months
measure: Compare difference in patient attitude towards the treatment between groups
timeFrame: 9 months
measure: Compare difference in patient attitude towards the treatment between groups
timeFrame: 12 months
measure: Compare number and duration of mood episodes between groups months
timeFrame: 3 months
measure: Compare number and duration of mood episodes between groups months
timeFrame: 6 months
measure: Compare number and duration of mood episodes between groups months
timeFrame: 9 months
measure: Compare number and duration of mood episodes between groups months
timeFrame: 12 months
measure: Compare number and duration of hospitalizations in psychiatric service between groups
timeFrame: 3 months
measure: Compare number and duration of hospitalizations in psychiatric service between groups
timeFrame: 6 months
measure: Compare number and duration of hospitalizations in psychiatric service between groups
timeFrame: 9 months
measure: Compare number and duration of hospitalizations in psychiatric service between groups
timeFrame: 12 months
measure: Compare manic symptomatology during evaluations between groups
timeFrame: 3 months
measure: Compare manic symptomatology during evaluations between groups
timeFrame: 6 months
measure: Compare manic symptomatology during evaluations between groups
timeFrame: 9 months
measure: Compare manic symptomatology during evaluations between groups
timeFrame: 12 months
measure: Compare the depressive symptomatology during evaluations between groups
timeFrame: 3 months
measure: Compare the depressive symptomatology during evaluations between groups
timeFrame: 6 months
measure: Compare the depressive symptomatology during evaluations between groups
timeFrame: 9 months
measure: Compare the depressive symptomatology during evaluations between groups
timeFrame: 12 months
measure: Compare severity and intensity of suicidal ideas between groups
timeFrame: 3 months
measure: Compare severity and intensity of suicidal ideas between groups
timeFrame: 6 months
measure: Compare severity and intensity of suicidal ideas between groups
timeFrame: 9 months
measure: Compare severity and intensity of suicidal ideas between groups
timeFrame: 12 months
measure: Compare the psychosocial functioning between groups
timeFrame: 3 months
measure: Compare the psychosocial functioning between groups
timeFrame: 6 months
measure: Compare the psychosocial functioning between groups
timeFrame: 9 months
measure: Compare the psychosocial functioning between groups
timeFrame: 12 months
measure: Compare quality of life between groups
timeFrame: 3 months
measure: Compare quality of life between groups
timeFrame: 6 months
measure: Compare quality of life between groups
timeFrame: 9 months
measure: Compare quality of life between groups
timeFrame: 12 months
measure: Compare length of consultations between groups
timeFrame: every consultation for 12 months
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 3 months
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 6 months
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 9 months
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
timeFrame: 12 months
measure: Clinician satisfaction concerning the decision-making process between groups
timeFrame: 3 months
measure: Clinician satisfaction concerning the decision-making process between groups
timeFrame: 6 months
measure: Clinician satisfaction concerning the decision-making process between groups
timeFrame: 9 months
measure: Clinician satisfaction concerning the decision-making process between groups
timeFrame: 12 months
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 3 months
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 6 months
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 9 months
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Beziers
country: France
facility: Ch Beziers
city: Bordeaux
country: France
facility: CH Charles Perrens
city: Bron
country: France
facility: CH le Vinatier
city: Clermont Ferrand
country: France
facility: Chu Gabriel Montpied Clermont Ferrand
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
city: Clermont-Ferrand
country: France
facility: CH Sainte-Marie de Clermont-Ferrand
city: Créteil
country: France
facility: APHP - Centre Hospitalier Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
city: Limoges
country: France
facility: CH Limoges
city: Marseille
country: France
facility: APHM - Hôpital Sainte-Marguerite
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: Clinique des troubles thymiques
city: Nîmes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Ludovic Samalin
role: PRINCIPAL_INVESTIGATOR
References:
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.