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Clinical Trials/NCT03471013
NCT03471013TerminatedNot Applicable

Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia

University Hospital, Clermont-Ferrand1 site in 1 country50 target enrollmentStarted: March 20, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Assessment of the correlation between caregiver beliefs about treatment and patient compliance

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Patients and caregivers

Patients suffering from schizophrenia accompanied by their caregiver

Outcomes

Primary Outcomes

Assessment of the correlation between caregiver beliefs about treatment and patient compliance

Time Frame: At day 1

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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