- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471013
Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia (CroyAid-SCZ)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients and caregivers
Patients suffering from schizophrenia accompanied by their caregiver
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the correlation between caregiver beliefs about treatment and patient compliance
Time Frame: At day 1
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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.
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At day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Ludovic SAMALIN, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-384
- 2017-A02271-52 (Other Identifier: 2017-A02271-52)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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