CONCORDE: Study of the Effectiveness of Specific Training of Health Professionals on Adherence in Bipolar Disorder

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT02904083

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorders	Behavioral: self assessment of adherence	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: specific training of professionals patients from centers where professionals have received specific training	Behavioral: self assessment of adherence
Active Comparator: control training of professionals patients from centers where professionals have received control training	Behavioral: self assessment of adherence

Arm

Intervention/Treatment

Experimental: specific training of professionals

patients from centers where professionals have received specific training

Behavioral: self assessment of adherence

Active Comparator: control training of professionals

patients from centers where professionals have received control training

Behavioral: self assessment of adherence

Outcome Measures

Primary Outcome Measures

Difference of score of Medication Adherence Rating Scale (MARS) before and after the training of the professionals [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13005

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Urielle Desalbres, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT02904083

Other Study ID Numbers:

2015-07

First Posted:

Sep 16, 2016

Last Update Posted:

Sep 16, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of Sep 16, 2016