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
Diagnosis established using ICD-11 clinical criteria [15].
Aged 18 years or older.
Registered on the Patient Portal.
With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).
Aged under 18 years old.
Unable to provide consent for medical or legal reasons.
Not registered on the Patient Portal.
No active prescription for antipsychotic drugs in the MUP.
Single group
Telehealth Psychoeducational Adherence Program
BehavioralParticipants with reduced antipsychotic treatment adherence will receive a structured telehealth psychoeducational program designed to improve medication adherence. The program includes 10 weekly online group sessions led by clinical psychologists and two peer-support sessions, focusing on illness and medication education, adherence strategies, problem-solving, digital medication-management tools, and relapse-prevention skills. Participants also receive supportive written materials.
Medication adherence measured by the Morisky Medication Adherence Scale (MMAS-7)
Score on the 7-item Morisky Medication Adherence Scale (MMAS-7), range 0-7, with lower scores indicating poorer adherence.
Antipsychotic medication exposure measured by Medication Use Profile (MUP)
Percentage of days covered (%) by antipsychotic medication over the 6 months prior to enrollment, calculated using dispensing data from the Single Prescription Module (MUP).
Validation of digital self-reported adherence against MUP dispensing data
Correlation between digital self-reported adherence questionnaire score (specify name, scale range) and percentage of days covered (%) from MUP records.
Correlation between sociodemographic variables and medication adherence (MMAS-7 score)
Correlation between sociodemographic variables obtained from the Patient Portal and adherence measured by MMAS-7 score (0-7 scale).
Correlation between sociodemographic variables and medication exposure (MUP %)
Correlation between sociodemographic variables and percentage of days covered (%) by antipsychotic medication based on MUP records.
Change in medication adherence after intervention (MMAS-7 score)
Change in MMAS-7 score (range 0-7) from baseline to 6 months post-intervention.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Hospital Universitario Fundación Jiménez Díaz
Collaborator
Hospital Infanta Elena de Valdemoro, Madrid
Collaborator
Hospital Universitario Rey Juan Carlos
Collaborator
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