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Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia (CroyAid-SCZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03471013
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : February 4, 2019
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease
DSM-5 Schizophrenia

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : March 2, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

Patients and caregivers
Patients suffering from schizophrenia accompanied by their caregiver

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of scizophrenia

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03471013

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Contact: Patrick LACARIN 0473751195

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Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195   
Principal Investigator: Ludovic SAMALIN         
Sub-Investigator: Isabelle JALENQUES         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Ludovic SAMALIN University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT03471013     History of Changes
Other Study ID Numbers: CHU-384
2017-A02271-52 ( Other Identifier: 2017-A02271-52 )
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs