Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:52 AM
Study NCT ID:
NCT07445802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Adherence in Severe Mental Illness: a Promotion Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1640}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence measured by the Morisky Medication Adherence Scale (MMAS-7)', 'timeFrame': 'Baseline (assessment of adherence over the previous 6 months prior to enrollment)', 'description': 'Score on the 7-item Morisky Medication Adherence Scale (MMAS-7), range 0-7, with lower scores indicating poorer adherence.'}, {'measure': 'Antipsychotic medication exposure measured by Medication Use Profile (MUP)', 'timeFrame': 'Baseline (medication exposure during the 6 months prior to enrollment)', 'description': 'Percentage of days covered (%) by antipsychotic medication over the 6 months prior to enrollment, calculated using dispensing data from the Single Prescription Module (MUP).'}], 'secondaryOutcomes': [{'measure': 'Validation of digital self-reported adherence against MUP dispensing data', 'timeFrame': 'Baseline (comparison of self-reported adherence and dispensing data for the 6 months prior to enrollment)', 'description': 'Correlation between digital self-reported adherence questionnaire score (specify name, scale range) and percentage of days covered (%) from MUP records.'}, {'measure': 'Correlation between sociodemographic variables and medication adherence (MMAS-7 score)', 'timeFrame': 'baseline', 'description': 'Correlation between sociodemographic variables obtained from the Patient Portal and adherence measured by MMAS-7 score (0-7 scale).'}, {'measure': 'Correlation between sociodemographic variables and medication exposure (MUP %)', 'timeFrame': 'Baseline (6 months prior to enrollment)', 'description': 'Correlation between sociodemographic variables and percentage of days covered (%) by antipsychotic medication based on MUP records.'}, {'measure': 'Change in medication adherence after intervention (MMAS-7 score)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Change in MMAS-7 score (range 0-7) from baseline to 6 months post-intervention.'}, {'measure': 'Change in percentage of days covered after intervention (MUP data)', 'timeFrame': 'Baseline and 6 months after intervention', 'description': 'Change in percentage of days covered (%) by antipsychotic medication from baseline (6 months prior to enrollment) to 6 months after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment adherence', 'schizophrenia', 'bipolar disorder', 'electronic health records', 'medication'], 'conditions': ['Treatment Adherence and Compliance', 'Severe Mental Disorders', 'Bipolar Disorder (BD)', 'Schizophrenia Disorder']}, 'referencesModule': {'references': [{'pmid': '31150942', 'type': 'RESULT', 'citation': 'Kelly JF, Hoffman L, Vilsaint C, Weiss R, Nierenberg A, Hoeppner B. Peer support for mood disorder: Characteristics and benefits from attending the Depression and Bipolar Support Alliance mutual-help organization. J Affect Disord. 2019 Aug 1;255:127-135. doi: 10.1016/j.jad.2019.05.039. Epub 2019 May 23.'}, {'pmid': '33761085', 'type': 'RESULT', 'citation': 'Orsi JA, Malinowski FRL, Kagan S, Weingarten R, Villares CC, Bressan RA, de Oliveira WF, Andrade MCR, Gadelha A. Evaluation of Ongoing Participation of People with Schizophrenia in a Mutual Support Group as a Complementary Intervention to Outpatient Psychiatric Treatment. Psychiatr Q. 2021 Sep;92(3):1283-1296. doi: 10.1007/s11126-021-09893-z. Epub 2021 Mar 24.'}, {'pmid': '28078204', 'type': 'RESULT', 'citation': 'Chakrabarti S. Treatment-adherence in bipolar disorder: A patient-centred approach. World J Psychiatry. 2016 Dec 22;6(4):399-409. doi: 10.5498/wjp.v6.i4.399. eCollection 2016 Dec 22.'}, {'pmid': '31077729', 'type': 'RESULT', 'citation': 'Kim J, Ozzoude M, Nakajima S, Shah P, Caravaggio F, Iwata Y, De Luca V, Graff-Guerrero A, Gerretsen P. Insight and medication adherence in schizophrenia: An analysis of the CATIE trial. Neuropharmacology. 2020 May 15;168:107634. doi: 10.1016/j.neuropharm.2019.05.011. Epub 2019 May 9.'}, {'pmid': '34639510', 'type': 'RESULT', 'citation': 'Loots E, Goossens E, Vanwesemael T, Morrens M, Van Rompaey B, Dilles T. Interventions to Improve Medication Adherence in Patients with Schizophrenia or Bipolar Disorders: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10213. doi: 10.3390/ijerph181910213.'}, {'pmid': '23714262', 'type': 'RESULT', 'citation': 'Gibson S, Brand SL, Burt S, Boden ZV, Benson O. Understanding treatment non-adherence in schizophrenia and bipolar disorder: a survey of what service users do and why. BMC Psychiatry. 2013 May 29;13:153. doi: 10.1186/1471-244X-13-153.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nWith 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.\n\nThe 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.\n\nParticipants 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.\n\nIf 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", 'detailedDescription': 'This study aims to evaluate the validity of digital self-reported treatment adherence questionnaires in comparison with objective pharmacy dispensing records for antipsychotic medications, identify predictors of non-adherence, and assess the effectiveness of a telehealth intervention designed to improve adherence among adults with schizophrenia or bipolar disorder.\n\nStudy Design\n\nThe protocol incorporates three linked components:\n\nValidation study: Sensitivity, specificity, predictive values, and ROC analysis will be used to determine the accuracy of digital adherence self-report scales compared with electronic dispensing data from the regional Single Prescription Module (MUP), considered the reference standard.\n\nObservational study: Sociodemographic and clinical variables obtained through the Patient Portal will be analyzed to identify correlates of adherence. Logistic regression and correlation models will be applied to examine associations between treatment exposure (continuous and categorical measures) and relevant predictors.\n\nPre-post intervention: Participants identified as having poor adherence will be offered a structured psychoeducational program delivered via videoconference. The program includes ten group sessions led by clinical psychologists and two peer-contributor sessions, focusing on knowledge reinforcement, self-management skills, and barriers to adherence. Medication exposure levels and self-report scores will be reassessed six months post-intervention.\n\nSetting and Population Participants will be recruited through four public hospitals in the Community of Madrid. Eligible individuals must be adults diagnosed with schizophrenia or bipolar disorder, registered in the digital patient portal, and have active antipsychotic prescriptions. Patients unable to provide informed consent or without portal access will be excluded. Consent will be obtained electronically.\n\nThe estimated eligible population is approximately 4,900 individuals. Expected questionnaire completion is \\~30%, yielding \\~1,640 participants for the validation component. Based on expected non-adherence rates (40-50%), approximately 650 participants are anticipated for the intervention phase.\n\nData Sources and Security Adherence outcomes will include digital self-report measures (Morisky-Green and Haynes-Sackett) and percentage of antipsychotic exposure obtained from the MUP over the prior six-month period. Sociodemographic and clinical characteristics (age, sex, urbanicity, comorbidities) will be extracted from the Patient Portal.\n\nPersonal identifiers will be pseudonymized and stored separately from study records. Access to data will be restricted to authorized study personnel. Digital infrastructure includes encrypted communication, firewalls, intrusion-detection systems, and periodic audit mechanisms. Data processing follows GDPR and Spanish data protection laws.\n\nStatistical Plan Analyses will employ SPSS and R. For the validation phase, diagnostic accuracy metrics and ROC curves will be calculated. For risk-factor analysis, logistic regression (using \\<75% exposure as a risk threshold) and correlation analyses will be performed. For intervention evaluation, pre-post comparisons of pharmacological exposure and questionnaire scores will be conducted using appropriate paired statistical tests.\n\nRisks and Burden The intervention consists of group psychoeducational telehealth sessions, with no known risks. Participants will not receive financial incentives. Data confidentiality and voluntary participation are ensured.\n\nStudy Relevance To our knowledge, this is the first Spanish study validating digital adherence questionnaires against real-world electronic dispensing data in patients with severe mental illness, and one of the first to integrate digital phenotyping with a peer-supported telehealth adherence program. The findings may support scalable, patient-centered models to improve adherence and long-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis established using ICD-11 clinical criteria \\[15\\].\n* Aged 18 years or older.\n* Registered on the Patient Portal.\n* With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).\n\nExclusion Criteria:\n\n* Aged under 18 years old.\n* Unable to provide consent for medical or legal reasons.\n* Not registered on the Patient Portal.\n* No active prescription for antipsychotic drugs in the MUP.'}, 'identificationModule': {'nctId': 'NCT07445802', 'acronym': 'ADHERA', 'briefTitle': 'Medication Adherence in Severe Mental Illness: a Promotion Program', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz'}, 'officialTitle': 'Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol', 'orgStudyIdInfo': {'id': 'PIC 76-2013_FJD-HIE-HRJC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with adherence problems in antipsychotic treatment', 'description': 'Pre-post comparison of participants identified with reduced antipsychotic medication adherence via electronic dispensing records and self-report measures will receive a structured psychoeducational adherence-support program. The intervention consists of ten online group telehealth sessions led by clinical psychologists, including two sessions with trained peer-support contributors who have lived experience of stable recovery. Sessions focus on education about illness and medication, strategies to improve adherence, problem-solving skills, digital medication management tools, and relapse-prevention planning. Participants also receive written psychoeducational materials. Duration: approximately 10 weeks, one session per week.', 'interventionNames': ['Behavioral: Telehealth Psychoeducational Adherence Program']}], 'interventions': [{'name': 'Telehealth Psychoeducational Adherence Program', 'type': 'BEHAVIORAL', 'otherNames': ['ADHERA'], 'description': 'Participants 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.', 'armGroupLabels': ['Patients with adherence problems in antipsychotic treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospital Infanta Elena de Valdemoro, Madrid', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}