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Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder

NCT07488156 — Not applicable, Not yet recruiting, 34 participants, Louisiana State University Health Sciences Center in New Orleans

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The Impact of Health Literacy on the Attitudes Toward Pharmacological Treatment in Patients With Schizophrenia Spectrum Disorder

RegistryNCT07488156
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment34 (Estimated)
SponsorLouisiana State University Health Sciences Center in New Orleans (Other); collaborators: Janssen Pharmaceuticals
ConditionsSchizophrenia Disorder, Schizoaffective Disorder, Psychosis
InterventionsEducational sessions (Behavioral)
Datesstart 2026-03-01 (estimated), primary completion 2027-07-30 (estimated), completion 2028-01-01 (estimated), first posted 2026-03-23, last updated 2026-03-23
Locations1 site in United States

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-Summary

The Impact of Health Literacy on the Attitudes toward Pharmacological Treatment in Patients with Schizophrenia Spectrum Disorder

This interventional study is aimed at:

* assessing and improving the health literacy and
* assessing the attitude towards treatment of patients with schizophrenia spectrum disorders while they are admitted to the inpatient psychiatric unit.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosisExperimentalBehavioral: Educational sessionsPatients will be exposed to educational materials in the form of a pamphlet and a video
  • Educational sessions (Behavioral): 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.

+Outcome measures

Primary outcomes

  • Post-intervention KAST (Knowledge About Schizophrenia Test) scores [This will be collected on Day 5 of the study, after the participant has completed both educational sessions.]: 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.
  • Post-intervention ATT (Attitudes Toward Treatment) scores [This will be collected on Day 5 of the study, after the participant has completed both educational sessions.]: 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.

Secondary outcomes

  • MARS (Medication Adherence Rating Scale) scores [This questionnaire will be given on a monthly basis in the follow up period, for a total of 12 months.]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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
* Patients must be proficient in English.
* Patients must have a government issued social security number (required for reimbursement through the university).

Exclusion Criteria:

* Patients at UMCNO that are ages 17 or younger
* 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
* Patients with concomitant substance use and documentation of psychosis being resolved after a period of washout and without the use of psychotropic medications
* Patients unable to complete health literacy assessments, attitude towards treatment assessments, and IQ testing due to severity of symptoms during hospitalization
* Patients that are not proficient in English
* Patients that do not have a government issued social security number

+Locations (1)

FacilityCityCountryStatus
University Medical CenterNew Orleans, LouisianaUnited States

+Publications

  • 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 31823381
  • 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 11042440
  • 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 24375208
  • 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 23052428
  • 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 23728232
  • 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 12334406
  • 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 11218181
  • 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 16532974
  • 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 23356468
  • 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 30526340
  • 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 36640734
  • 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 18971402
  • 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. PMID 27079987

+Study documents

My Notes