Not yet recruiting NCT07488156

Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder

No phase Interventional Schizophrenia Disorder Schizoaffective Disorder Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Educational sessions.
Who it may be relevant to: Registry conditions: Schizophrenia Disorder, Schizoaffective Disorder, Psychosis. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

Behavioral Educational sessions
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 to

Primary outcome measures

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

Secondary outcome measures (1)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Other

Study locations

United States · 1 center

University Medical Center — New Orleans

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

Identifiers

NCT: NCT07488156 · 8277 · R076477SCH4075

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗