Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

Bipolar Disorder Clinical Trial

— ShareD-BD  

Official title:

Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245593
• Other study ID #: PREPS/2016/LS-01
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Ludovic Samalin, MD
• Phone: +33 (0)4 73 752 125
• Email: lsamalin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Shared-decision making process
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 care
Care of patients according to standard practice of managing patients with bipolar disorder

Locations

Country	Name	City	State
France	Ch Beziers	Beziers
France	CH Charles Perrens	Bordeaux
France	CH le Vinatier	Bron
France	Chu Gabriel Montpied Clermont Ferrand	Clermont Ferrand
France	CH Sainte-Marie de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Clermont Ferrand - Hôpital Gabriel-Montpied	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	CHU Nimes	Nîmes
France	Clinique des troubles thymiques	Nîmes
France	APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Secondary	Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	3 months
Secondary	Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	6 months
Secondary	Study the clinician-reported difference between the 2 groups in medication adherence	Clinician Rating Scale (1-7)	9 months
Secondary	Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	3 months
Secondary	Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	6 months
Secondary	Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	9 months
Secondary	Study the self-reported difference between the 2 groups in medication adherence	Medication Adherence Rating Scale( 0-10),	12 months
Secondary	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	3 months
Secondary	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	6 months
Secondary	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	9 months
Secondary	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	12 months
Secondary	Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	3 months
Secondary	Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	6 months
Secondary	Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	9 months
Secondary	Compare difference in the adherence to personalized follow-up between groups	percentage of consultations missed	12 months
Secondary	Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	3 months
Secondary	Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	6 months
Secondary	Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	9 months
Secondary	Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale (0-100)	12 months
Secondary	Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	3 months
Secondary	Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	6 months
Secondary	Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	9 months
Secondary	Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45: 3 questions scored 1-5	12 months
Secondary	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	3 months
Secondary	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	6 months
Secondary	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	9 months
Secondary	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	12 months
Secondary	Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	3 months
Secondary	Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	6 months
Secondary	Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	9 months
Secondary	Compare difference in therapeutic alliance between groups	4-Point ordinal Alliance Scale	12 months
Secondary	Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	3 months
Secondary	Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	6 months
Secondary	Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	9 months
Secondary	Compare difference in knowledge of disease and treatment necessary to making decisions between groups	Knowledge questionnaire: % correct answers	12 months
Secondary	Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	3 months
Secondary	Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	6 months
Secondary	Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	9 months
Secondary	Compare difference in patient attitude towards the treatment between groups	Beliefs about Medicines Questionnaire: 18 questions 1-5	12 months
Secondary	Compare number and duration of mood episodes between groups months	number of events; number of days	3 months
Secondary	Compare number and duration of mood episodes between groups months	number of events; number of days	6 months
Secondary	Compare number and duration of mood episodes between groups months	number of events; number of days	9 months
Secondary	Compare number and duration of mood episodes between groups months	number of events; number of days	12 months
Secondary	Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	3 months
Secondary	Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	6 months
Secondary	Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	9 months
Secondary	Compare number and duration of hospitalizations in psychiatric service between groups	number of events; number of days	12 months
Secondary	Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	3 months
Secondary	Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	6 months
Secondary	Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	9 months
Secondary	Compare manic symptomatology during evaluations between groups	Young Mania Rating Scale	12 months
Secondary	Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	3 months
Secondary	Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	6 months
Secondary	Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	9 months
Secondary	Compare the depressive symptomatology during evaluations between groups	Montgomery-Asberg Depression Rating Scale	12 months
Secondary	Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	3 months
Secondary	Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	6 months
Secondary	Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	9 months
Secondary	Compare severity and intensity of suicidal ideas between groups	Columbia-Suicide Severity Rating Scale	12 months
Secondary	Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	3 months
Secondary	Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	6 months
Secondary	Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	9 months
Secondary	Compare the psychosocial functioning between groups	Functioning Assessment Short Test (0-72)	12 months
Secondary	Compare quality of life between groups	WHOQOL-BREF (0-100)	3 months
Secondary	Compare quality of life between groups	WHOQOL-BREF (0-100)	6 months
Secondary	Compare quality of life between groups	WHOQOL-BREF (0-100)	9 months
Secondary	Compare quality of life between groups	WHOQOL-BREF (0-100)	12 months
Secondary	Compare length of consultations between groups	minutes	every consultation for 12 months
Secondary	Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	3 months
Secondary	Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	6 months
Secondary	Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	9 months
Secondary	Clinician satisfaction concerning the therapeutic decisions taken between groups	adapted QSH-45 doctor version 3 questions scored 1-5	12 months
Secondary	Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	3 months
Secondary	Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	6 months
Secondary	Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	9 months
Secondary	Clinician satisfaction concerning the decision-making process between groups	Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5	12 months
Secondary	Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	3 months
Secondary	Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	6 months
Secondary	Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	9 months
Secondary	Clinician perceptions related to the uncertainty of the medical decisions taken between groups	decisional conflict scale doctor version (0-100)	12 months