Improving Health Literacy in Patients With Schizophrenia Spectrum Disorder

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center
        • Contact:
        • Principal Investigator:
          • Jaudé Petrie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients admitted to the inpatient psychiatric unit with a schizophrenia spectrum disorder diagnosis
Patients will be exposed to educational materials in the form of a pamphlet and a video
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
This will be collected on Day 5 of the study, after the participant has completed both educational sessions.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
This questionnaire will be given on a monthly basis in the follow up period, for a total of 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 8277
  • R076477SCH4075 (Other Grant/Funding Number: Janssen Scientific Affairs, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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