ShareD-BD: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Shared Decision making for care
|
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 decision making for care
|
Other: standard care
Care of patients according to standard practice of managing patients with bipolar disorder
|
Outcome Measures
Primary Outcome Measures
- 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
- Study the clinician-reported difference between the 2 groups in medication adherence [3 months]
Clinician Rating Scale (1-7)
- Study the clinician-reported difference between the 2 groups in medication adherence [6 months]
Clinician Rating Scale (1-7)
- Study the clinician-reported difference between the 2 groups in medication adherence [9 months]
Clinician Rating Scale (1-7)
- Study the self-reported difference between the 2 groups in medication adherence [3 months]
Medication Adherence Rating Scale( 0-10),
- Study the self-reported difference between the 2 groups in medication adherence [6 months]
Medication Adherence Rating Scale( 0-10),
- Study the self-reported difference between the 2 groups in medication adherence [9 months]
Medication Adherence Rating Scale( 0-10),
- 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 [3 months]
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
- Clinical evaluation of the difference between the 2 groups in medication adherence [6 months]
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
- Clinical evaluation of the difference between the 2 groups in medication adherence [9 months]
Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
- 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 the adherence to personalized follow-up between groups [3 months]
percentage of consultations missed
- Compare difference in the adherence to personalized follow-up between groups [6 months]
percentage of consultations missed
- Compare difference in the adherence to personalized follow-up between groups [9 months]
percentage of consultations missed
- 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 [3 months]
decisional conflict scale (0-100)
- Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups [6 months]
decisional conflict scale (0-100)
- Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups [9 months]
decisional conflict scale (0-100)
- Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups [12 months]
decisional conflict scale (0-100)
- Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups [3 months]
adapted QSH-45: 3 questions scored 1-5
- Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups [6 months]
adapted QSH-45: 3 questions scored 1-5
- Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups [9 months]
adapted QSH-45: 3 questions scored 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 [3 months]
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
- Compare difference in patient satisfaction concerning the decision-making process between groups [6 months]
Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
- Compare difference in patient satisfaction concerning the decision-making process between groups [9 months]
Adapted clinical decision making involvement and satisfaction score 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 difference in therapeutic alliance between groups [3 months]
4-Point ordinal Alliance Scale
- Compare difference in therapeutic alliance between groups [6 months]
4-Point ordinal Alliance Scale
- Compare difference in therapeutic alliance between groups [9 months]
4-Point ordinal Alliance Scale
- 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 [3 months]
Knowledge questionnaire: % correct answers
- Compare difference in knowledge of disease and treatment necessary to making decisions between groups [6 months]
Knowledge questionnaire: % correct answers
- Compare difference in knowledge of disease and treatment necessary to making decisions between groups [9 months]
Knowledge questionnaire: % correct answers
- Compare difference in knowledge of disease and treatment necessary to making decisions between groups [12 months]
Knowledge questionnaire: % correct answers
- Compare difference in patient attitude towards the treatment between groups [3 months]
Beliefs about Medicines Questionnaire: 18 questions 1-5
- Compare difference in patient attitude towards the treatment between groups [6 months]
Beliefs about Medicines Questionnaire: 18 questions 1-5
- Compare difference in patient attitude towards the treatment between groups [9 months]
Beliefs about Medicines Questionnaire: 18 questions 1-5
- Compare difference in patient attitude towards the treatment between groups [12 months]
Beliefs about Medicines Questionnaire: 18 questions 1-5
- Compare number and duration of mood episodes between groups months [3 months]
number of events; number of days
- Compare number and duration of mood episodes between groups months [6 months]
number of events; number of days
- Compare number and duration of mood episodes between groups months [9 months]
number of events; number of days
- Compare number and duration of mood episodes between groups months [12 months]
number of events; number of days
- Compare number and duration of hospitalizations in psychiatric service between groups [3 months]
number of events; number of days
- Compare number and duration of hospitalizations in psychiatric service between groups [6 months]
number of events; number of days
- Compare number and duration of hospitalizations in psychiatric service between groups [9 months]
number of events; number of days
- Compare number and duration of hospitalizations in psychiatric service between groups [12 months]
number of events; number of days
- Compare manic symptomatology during evaluations between groups [3 months]
Young Mania Rating Scale
- Compare manic symptomatology during evaluations between groups [6 months]
Young Mania Rating Scale
- Compare manic symptomatology during evaluations between groups [9 months]
Young Mania Rating Scale
- Compare manic symptomatology during evaluations between groups [12 months]
Young Mania Rating Scale
- Compare the depressive symptomatology during evaluations between groups [3 months]
Montgomery-Asberg Depression Rating Scale
- Compare the depressive symptomatology during evaluations between groups [6 months]
Montgomery-Asberg Depression Rating Scale
- Compare the depressive symptomatology during evaluations between groups [9 months]
Montgomery-Asberg Depression Rating Scale
- Compare the depressive symptomatology during evaluations between groups [12 months]
Montgomery-Asberg Depression Rating Scale
- Compare severity and intensity of suicidal ideas between groups [3 months]
Columbia-Suicide Severity Rating Scale
- Compare severity and intensity of suicidal ideas between groups [6 months]
Columbia-Suicide Severity Rating Scale
- Compare severity and intensity of suicidal ideas between groups [9 months]
Columbia-Suicide Severity Rating Scale
- Compare severity and intensity of suicidal ideas between groups [12 months]
Columbia-Suicide Severity Rating Scale
- Compare the psychosocial functioning between groups [3 months]
Functioning Assessment Short Test (0-72)
- Compare the psychosocial functioning between groups [6 months]
Functioning Assessment Short Test (0-72)
- Compare the psychosocial functioning between groups [9 months]
Functioning Assessment Short Test (0-72)
- Compare the psychosocial functioning between groups [12 months]
Functioning Assessment Short Test (0-72)
- Compare quality of life between groups [3 months]
WHOQOL-BREF (0-100)
- Compare quality of life between groups [6 months]
WHOQOL-BREF (0-100)
- Compare quality of life between groups [9 months]
WHOQOL-BREF (0-100)
- Compare quality of life between groups [12 months]
WHOQOL-BREF (0-100)
- Compare length of consultations between groups [every consultation for 12 months]
minutes
- Clinician satisfaction concerning the therapeutic decisions taken between groups [3 months]
adapted QSH-45 doctor version 3 questions scored 1-5
- Clinician satisfaction concerning the therapeutic decisions taken between groups [6 months]
adapted QSH-45 doctor version 3 questions scored 1-5
- Clinician satisfaction concerning the therapeutic decisions taken between groups [9 months]
adapted QSH-45 doctor version 3 questions scored 1-5
- Clinician satisfaction concerning the therapeutic decisions taken between groups [12 months]
adapted QSH-45 doctor version 3 questions scored 1-5
- Clinician satisfaction concerning the decision-making process between groups [3 months]
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
- Clinician satisfaction concerning the decision-making process between groups [6 months]
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
- Clinician satisfaction concerning the decision-making process between groups [9 months]
Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
- 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
- Clinician perceptions related to the uncertainty of the medical decisions taken between groups [3 months]
decisional conflict scale doctor version (0-100)
- Clinician perceptions related to the uncertainty of the medical decisions taken between groups [6 months]
decisional conflict scale doctor version (0-100)
- Clinician perceptions related to the uncertainty of the medical decisions taken between groups [9 months]
decisional conflict scale doctor version (0-100)
- Clinician perceptions related to the uncertainty of the medical decisions taken between groups [12 months]
decisional conflict scale doctor version (0-100)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Charles Perrens | Bordeaux | France | 33076 | |
| 2 | CH le Vinatier | Bron | France | 69678 | |
| 3 | CHU de Clermont Ferrand - Hôpital Gabriel-Montpied | Clermont-Ferrand | France | 63003 | |
| 4 | CH Sainte-Marie de Clermont-Ferrand | Clermont-Ferrand | France | 63037 | |
| 5 | APHP - Centre Hospitalier Henri Mondor | Créteil | France | 94010 | |
| 6 | CHU de Grenoble - Hôpital Albert Michallon | Grenoble | France | 38043 | |
| 7 | CH Limoges | Limoges | France | 87025 | |
| 8 | APHM - Hôpital Sainte-Marguerite | Marseille | France | 13274 | |
| 9 | CHU de Montpellier - Hôpital Lapeyronie | Montpellier | France | 34295 | |
| 10 | CHU Nancy | Nancy | France | 54000 | |
| 11 | CHU Nantes | Nantes | France | 44000 | |
| 12 | Clinique des troubles thymiques | Nîmes | France | 30000 | |
| 13 | CHU Nimes | Nîmes | France | 30029 | |
| 14 | APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal | Paris | France | 75475 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Ludovic Samalin, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PREPS/2016/LS-01