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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03471013
Other study ID # CHU-384
Secondary ID 2017-A02271-52
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2018
Est. completion date March 30, 2019

Study information

Verified date February 2019
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 0473751195
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.


Description:

Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 30, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient over 18 years old

- With a diagnosis of schizophrenia according to DSM-5 criteria

- Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.

- Treated with one or more antipsychotics.

- Able to complete the questionnaires related to the protocol

- Having agreed to sign the information form.

Exclusion Criteria:

- Not understanding French, unable to answer questions linguistically

- Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview

- Having already participated in the study

- presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the correlation between caregiver beliefs about treatment and patient compliance The caregiver beliefs are evaluated by the Beliefs about Medicines Questionnaire, the patient compliance is evaluated by the investigator with Behaviourally Anchored Rating Scales and by the patient him-self with Morisky Medication Adherence Scale, and the level of caregiver-patient link is evaluated with Involvement Evaluation Questionnaire. At day 1