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Medication Adherence in Severe Mental Illness: a Promotion Program

Study acronym: ADHERA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias. With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence. The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence. Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months. If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions
Trial Details
NCT Number NCT07445802
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Hospital Universitario Fundación Jiménez Díaz, Hospital Infanta Elena de Valdemoro, Madrid, Hospital Universitario Rey Juan Carlos
Conditions
(from sponsor)		 Treatment Adherence and Compliance, Severe Mental Disorders, Bipolar Disorder (BD), Schizophrenia Disorder
Related terms Bipolar Disorder, Mental Disorders, Schizophrenia, Treatment Adherence and Compliance
Enrollment 1,640 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov