NCT03245593进行中（未招募）不适用
Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Centre Hospitalier Universitaire de Nīmes32 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 32
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 12 months
Clinician Rating Scale (1-7)
次要结局
- Study the clinician-reported difference between the 2 groups in medication adherence(9 months)
- Compare difference in therapeutic alliance between groups(12 months)
- Compare difference in knowledge of disease and treatment necessary to making decisions between groups(12 months)
- Clinician satisfaction concerning the decision-making process between groups(12 months)
- Study the self-reported difference between the 2 groups in medication adherence(12 months)
- Clinical evaluation of the difference between the 2 groups in medication adherence(12 months)
- Compare difference in patient attitude towards the treatment between groups(12 months)
- Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups(12 months)
- Compare difference in patient satisfaction concerning the decision-making process between groups(12 months)
- Compare severity and intensity of suicidal ideas between groups(12 months)
- Compare difference in the adherence to personalized follow-up between groups(12 months)
- Compare the depressive symptomatology during evaluations between groups(12 months)
- Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups(12 months)
- Compare number and duration of mood episodes between groups months(12 months)
- Compare manic symptomatology during evaluations between groups(12 months)
- Compare number and duration of hospitalizations in psychiatric service between groups(12 months)
- Compare quality of life between groups(12 months)
- Clinician satisfaction concerning the therapeutic decisions taken between groups(12 months)
- Clinician perceptions related to the uncertainty of the medical decisions taken between groups(12 months)
- Compare the psychosocial functioning between groups(12 months)
- Compare length of consultations between groups(every consultation for 12 months)
研究者
研究点 (32)
Loading locations...
相似试验
Unknown
不适用
Creation of a Shared Medical Decision-making Tool for Atopic DermatitisAtopic DermatitisNCT05090982Assistance Publique - Hôpitaux de Paris150
招募中
不适用
Shared Decision-making and Antimicrobial Stewardship in Secondary CareNCT06605820Royal Cornwall Hospitals Trust50
已完成
不适用
Shared Decision Making About Medication Use for People With Multiple Health ProblemsPolypharmacyMultiple Chronic ConditionsDeprescribingMild Cognitive ImpairmentDementiaNCT05156073Johns Hopkins University22
Enrolling By Invitation
不适用
Promoting Shared Decision Making for Severe Aortic StenosisAortic StenosisNCT06171737Massachusetts General Hospital1,300
招募中
不适用
Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease TreatmentADPKD (autosomal Dominant Polycystic Kidney Disease)NCT06618638Seoul National University Hospital340