Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 2:59 AM
Study NCT ID:
NCT07488156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-01', 'size': 426856, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-01-19T13:31', 'hasProtocol': True}, {'date': '2025-11-17', 'size': 543881, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-01-19T13:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2025-11-07', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-intervention KAST (Knowledge About Schizophrenia Test) scores', 'timeFrame': 'This will be collected on Day 5 of the study, after the participant has completed both educational sessions.', 'description': 'This includes an 18-item multiple choice test, with only one correct answer for each item. Scores range from 0 to 100%. Higher scores indicate a higher level of knowledge.'}, {'measure': 'Post-intervention ATT (Attitudes Toward Treatment) scores', 'timeFrame': 'This will be collected on Day 5 of the study, after the participant has completed both educational sessions.', 'description': 'This test includes a total of 20 questions, each ranging from 0 to 10 points. Total score ranges from 0 to 200 points. Higher scores indicate a more favorable attitude towards medications.'}], 'secondaryOutcomes': [{'measure': 'MARS (Medication Adherence Rating Scale) scores', 'timeFrame': 'This questionnaire will be given on a monthly basis in the follow up period, for a total of 12 months.', 'description': 'This is a 10-item questionnaire with only yes and no answer choices. Participants will be given 0 points for answers that represent poor adherence and they will be given 10 points for answers that represent good adherence. Scores will range from 0 to 100 points, with higher scores indicating more adherence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Educational interventions', 'Schizophrenia', 'Schizophrenia spectrum disorders', 'Health literacy'], 'conditions': ['Schizophrenia Disorder', 'Schizoaffective Disorder', 'Psychosis']}, 'referencesModule': {'references': [{'pmid': '31823381', 'type': 'BACKGROUND', 'citation': "Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18."}, {'pmid': '11042440', 'type': 'BACKGROUND', 'citation': 'Kampman O, Lehtinen K, Lassila V, Leinonen E, Poutanen O, Koivisto A. Attitudes towards neuroleptic treatment: reliability and validity of the attitudes towards neuroleptic treatment (ANT) questionnaire. Schizophr Res. 2000 Oct 27;45(3):223-34. doi: 10.1016/s0920-9964(99)00204-2.'}, {'pmid': '24375208', 'type': 'BACKGROUND', 'citation': 'Chan KW, Hui LM, Wong HY, Lee HM, Chang WC, Chen YH. Medication adherence, knowledge about psychosis, and insight among patients with a schizophrenia-spectrum disorder. J Nerv Ment Dis. 2014 Jan;202(1):25-9. doi: 10.1097/NMD.0000000000000068.'}, {'pmid': '23052428', 'type': 'BACKGROUND', 'citation': 'von dem Knesebeck O, Mnich E, Daubmann A, Wegscheider K, Angermeyer MC, Lambert M, Karow A, Harter M, Kofahl C. Socioeconomic status and beliefs about depression, schizophrenia and eating disorders. Soc Psychiatry Psychiatr Epidemiol. 2013 May;48(5):775-82. doi: 10.1007/s00127-012-0599-1. Epub 2012 Oct 10.'}, {'pmid': '23728232', 'type': 'BACKGROUND', 'citation': 'Tsai KY, Chung TC, Lee CC, Chou YM, Su CY, Shen SP, Lin CH, Chou FH. Is low individual socioeconomic status (SES) in high-SES areas the same as low individual SES in low-SES areas: a 10-year follow-up schizophrenia study. Soc Psychiatry Psychiatr Epidemiol. 2014 Jan;49(1):89-96. doi: 10.1007/s00127-013-0716-9. Epub 2013 Jun 2.'}, {'pmid': '12334406', 'type': 'BACKGROUND', 'citation': 'Sharp HC. Vasectomy as a means of preventing procreation in defectives. J Am Med Assoc. 1909 Dec 4;53(23):1897-902. doi: 10.1001/jama.1909.92550230009002e.'}, {'pmid': '11218181', 'type': 'BACKGROUND', 'citation': "Freimuth VS, Quinn SC, Thomas SB, Cole G, Zook E, Duncan T. African Americans' views on research and the Tuskegee Syphilis Study. Soc Sci Med. 2001 Mar;52(5):797-808. doi: 10.1016/s0277-9536(00)00178-7."}, {'pmid': '16532974', 'type': 'BACKGROUND', 'citation': 'Hamilton LA, Aliyu MH, Lyons PD, May R, Swanson CL Jr, Savage R, Go RC. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc. 2006 Jan;98(1):18-27.'}, {'pmid': '23356468', 'type': 'BACKGROUND', 'citation': "Cheng HL, Kwan KL, Sevig T. Racial and ethnic minority college students' stigma associated with seeking psychological help: Examining psychocultural correlates. J Couns Psychol. 2013 Jan;60(1):98-111. doi: 10.1037/a0031169."}, {'pmid': '30526340', 'type': 'BACKGROUND', 'citation': 'Gara MA, Minsky S, Silverstein SM, Miskimen T, Strakowski SM. A Naturalistic Study of Racial Disparities in Diagnoses at an Outpatient Behavioral Health Clinic. Psychiatr Serv. 2019 Feb 1;70(2):130-134. doi: 10.1176/appi.ps.201800223. Epub 2018 Dec 10.'}, {'pmid': '36640734', 'type': 'BACKGROUND', 'citation': 'van Hooijdonk CFM, van der Pluijm M, Bosch I, van Amelsvoort TAMJ, Booij J, de Haan L, Selten JP, Giessen EV. The substantia nigra in the pathology of schizophrenia: A review on post-mortem and molecular imaging findings. Eur Neuropsychopharmacol. 2023 Mar;68:57-77. doi: 10.1016/j.euroneuro.2022.12.008. Epub 2023 Jan 12.'}, {'pmid': '18971402', 'type': 'BACKGROUND', 'citation': 'Alegria M, Chatterji P, Wells K, Cao Z, Chen CN, Takeuchi D, Jackson J, Meng XL. Disparity in depression treatment among racial and ethnic minority populations in the United States. Psychiatr Serv. 2008 Nov;59(11):1264-72. doi: 10.1176/ps.2008.59.11.1264.'}, {'pmid': '27079987', 'type': 'BACKGROUND', 'citation': 'Coleman KJ, Stewart C, Waitzfelder BE, Zeber JE, Morales LS, Ahmed AT, Ahmedani BK, Beck A, Copeland LA, Cummings JR, Hunkeler EM, Lindberg NM, Lynch F, Lu CY, Owen-Smith AA, Trinacty CM, Whitebird RR, Simon GE. Racial-Ethnic Differences in Psychiatric Diagnoses and Treatment Across 11 Health Care Systems in the Mental Health Research Network. Psychiatr Serv. 2016 Jul 1;67(7):749-57. doi: 10.1176/appi.ps.201500217. Epub 2016 Apr 15.'}], 'seeAlsoLinks': [{'url': 'https://vizhub.healthdata.org/gbd-results/', 'label': 'Institute of Health Metrics and Evaluation. Global Health Data Exchange'}]}, 'descriptionModule': {'briefSummary': 'The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder\n\nThis interventional study is aimed at:\n\n* assessing and improving the health literacy and\n* assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.', 'detailedDescription': 'The study will take place at University Medical Center in New Orleans, LA and will include 34 patients with a schizophrenia spectrum disorder diagnosis who are admitted to the psychiatric unit. Participants will take tests to assess their knowledge of SSD before and after receiving educational materials during their hospitalization. They will also receive questionnaires assessing their attitudes toward treatment before and after the educational interventions. After each patient is provided with educational material, they will be allowed to ask the healthcare provider questions pertaining to schizophrenia. Following discharge, patients will be followed for a total of 12 months, where they will be called to answer questions about medication adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the University Medical Center-New Orleans (UMCNO) inpatient behavioral health unit ages 18 and older with a new or previous diagnosis of schizophrenia spectrum disorder outside of substance use disorders\n* Patients must be proficient in English.\n* Patients must have a government issued social security number (required for reimbursement through the university).\n\nExclusion Criteria:\n\n* Patients at UMCNO that are ages 17 or younger\n* Patients with SSD and concomitant intellectual disability, as evidenced by prior documented history on chart review or patients suspected to have intellectual disability or impairment based on clinical interactions\n* Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications\n* Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization\n* Patients that are not proficient in English\n* Patients that do not have a government issued social security number'}, 'identificationModule': {'nctId': 'NCT07488156', 'briefTitle': 'Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder', 'orgStudyIdInfo': {'id': '8277'}, 'secondaryIdInfos': [{'id': 'R076477SCH4075', 'type': 'OTHER_GRANT', 'domain': 'Janssen Scientific Affairs, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis', 'description': 'Patients will be exposed to educational materials in the form of a pamphlet and a video', 'interventionNames': ['Behavioral: Educational sessions']}], 'interventions': [{'name': 'Educational sessions', 'type': 'BEHAVIORAL', 'description': 'Patients will be given an educational pamphlet with information about schizophrenia spectrum disorders, including prognosis and management options. Following this, they will be allowed to ask the doctor any questions they have pertaining to schizophrenia spectrum disorder. In the second educational session, patients will watch a video containing information about schizophrenia spectrum disorders. Following this, they will be allowed to ask the doctor any questions they have pertaining to this topic.', 'armGroupLabels': ['Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'contacts': [{'name': 'Jaudé Petrie, MD', 'role': 'CONTACT', 'email': 'jpetri@lsuhsc.edu', 'phone': '504-702-3000'}, {'name': 'Jaudé Petrie, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}