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Enhancing Immune Health Randomized Controlled Trial

Primary Purpose

Mental Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhancing Your Immune Health
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 and older Serious mental illness Membership in a collaborating community mental health agency Access to the Internet Able to provide informed consent Exclusion Criteria: Cognitive impairment preventing informed consent Unable to communicate in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental: Intervention

    Services as Usual

    Arm Description

    Subjects receive a brief intervention to improve their immune health literacy and self-management skills.

    Subjects receive routine mental health care.

    Outcomes

    Primary Outcome Measures

    Change in Immune Status
    The Immune Status Questionnaire (ISQ) measures self-reported immune status. The questionnaire consists of 7 items measuring indicators of immune health including headache, muscle and joint pain, cough, and sudden high fever. Respondents rate each item using a 5-point Likert scale ranging from "never" to "always or almost always." Responses are coded 0-4 and summed for a total score potentially ranging from 0 to 28 with higher scores indicating a poorer immune status.

    Secondary Outcome Measures

    Change in Perceived Competence for Health Management
    The Perceived Competence for Health Management scale measures participants' feelings of competence about their ability to manage their immune health. This 4-item scale uses a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
    Change in Coping Mastery
    Change in subjects' sense of personal control over important life outcomes is assessed via 7 items of the Coping Mastery Scale rated along a 4-point Likert scale from "strongly disagree" to "strongly agree." Higher values equal better coping mastery. Minimum=2 and maximum=49.
    Change in Health Promoting Lifestyle
    The ability to engage in health promoting behaviors and practices is assessed via self-report on a 26-item Health Promoting Lifestyle Profile II scale that yields a total score and 3 subscales measuring nutrition, physical activity, and emotional and spiritual wellness.

    Full Information

    First Posted
    November 1, 2022
    Last Updated
    May 8, 2023
    Sponsor
    University of Illinois at Chicago
    Collaborators
    National Institute on Disability, Independent Living, and Rehabilitation Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05639881
    Brief Title
    Enhancing Immune Health Randomized Controlled Trial
    Official Title
    Enhancing Immune Health Literacy and Behavior Among People With Psychiatric Disabilities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 31, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    February 28, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    National Institute on Disability, Independent Living, and Rehabilitation Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.
    Detailed Description
    This study is testing the efficacy of a brief intervention designed to improve immune health literacy and behaviors among adults with mental illnesses. This psychoeducational intervention supports lifestyle changes, including promotion of immunity-enhancing nutrition and immunity aids, activated intentions to receive needed inoculations and annual health screenings, better sleep, and more effective stress management. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline, two months post-baseline, and three months later. Multivariable analysis models are used to assess the primary outcome of self-reported immune status.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The intervention improves health literacy and self-management skills using a framework comprised of the psychoeducational strategies of explanation, evaluation, and engagement. Over the course of 5 structured sessions, instructors impart immune health information using visual aids. They evaluate what participants already know about immune health to assess how to expand participants' understanding of immunity and health self-management. Instructors engage participants in personally-meaningful activities and goals to improve their immune health literacy and behaviors. For 3 months after class ends, monthly booster sessions are held.
    Masking
    Outcomes Assessor
    Masking Description
    Research interviewers are blinded to study condition.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Intervention
    Arm Type
    Experimental
    Arm Description
    Subjects receive a brief intervention to improve their immune health literacy and self-management skills.
    Arm Title
    Services as Usual
    Arm Type
    Active Comparator
    Arm Description
    Subjects receive routine mental health care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhancing Your Immune Health
    Intervention Description
    In addition to routine mental health care, subjects receive an intervention to improve their immune health literacy and self-management behaviors.
    Primary Outcome Measure Information:
    Title
    Change in Immune Status
    Description
    The Immune Status Questionnaire (ISQ) measures self-reported immune status. The questionnaire consists of 7 items measuring indicators of immune health including headache, muscle and joint pain, cough, and sudden high fever. Respondents rate each item using a 5-point Likert scale ranging from "never" to "always or almost always." Responses are coded 0-4 and summed for a total score potentially ranging from 0 to 28 with higher scores indicating a poorer immune status.
    Time Frame
    study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
    Secondary Outcome Measure Information:
    Title
    Change in Perceived Competence for Health Management
    Description
    The Perceived Competence for Health Management scale measures participants' feelings of competence about their ability to manage their immune health. This 4-item scale uses a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
    Time Frame
    study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
    Title
    Change in Coping Mastery
    Description
    Change in subjects' sense of personal control over important life outcomes is assessed via 7 items of the Coping Mastery Scale rated along a 4-point Likert scale from "strongly disagree" to "strongly agree." Higher values equal better coping mastery. Minimum=2 and maximum=49.
    Time Frame
    study entry (pre-intervention), immediate post-intervention, 3 months post-intervention
    Title
    Change in Health Promoting Lifestyle
    Description
    The ability to engage in health promoting behaviors and practices is assessed via self-report on a 26-item Health Promoting Lifestyle Profile II scale that yields a total score and 3 subscales measuring nutrition, physical activity, and emotional and spiritual wellness.
    Time Frame
    study entry (pre-intervention), immediate post-intervention, 3 months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 and older Serious mental illness Membership in a collaborating community mental health agency Access to the Internet Able to provide informed consent Exclusion Criteria: Cognitive impairment preventing informed consent Unable to communicate in English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Judith A Cook, Ph.D.
    Phone
    312-355-3921
    Email
    jcook@uic.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Enhancing Immune Health Randomized Controlled Trial

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