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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02904083
Other study ID # 2015-07
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 8, 2016
Last updated September 13, 2016
Start date June 2017
Est. completion date June 2020

Study information

Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Raoul Belzeaux, MD
Email raoul.belzeaux@ap-hm.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Interventional

Clinical Trial Summary

Bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. In addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. Poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. Considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. Adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. This fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. However, this factor seems modifiable by better training of professionals. A team from Newcastle University in England has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. The investigators assume that this training will improve medication adherence among outpatients by trained professionals.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 2020
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Suffering from bipolar disorder type 1, type 2 or unspecified according to the DSM IV

- Do not presenting mood episode as defined in DSM IV

- With at least one medication prescribed mood stabilizer goal, whatever its observance

Exclusion Criteria:

- Patients full-time hospitalized at the time of inclusion

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
self assessment of adherence


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference of score of Medication Adherence Rating Scale (MARS) before and after the training of the professionals 6 months No
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