NCT02904083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 8, 2016

Last Update Submit

September 13, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference of score of Medication Adherence Rating Scale (MARS) before and after the training of the professionals

    6 months

Study Arms (2)

specific training of professionals

EXPERIMENTAL

patients from centers where professionals have received specific training

Behavioral: self assessment of adherence

control training of professionals

ACTIVE COMPARATOR

patients from centers where professionals have received control training

Behavioral: self assessment of adherence

Interventions

control training of professionalsspecific training of professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Urielle Desalbres

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Raoul Belzeaux, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 16, 2016

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations