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Narrative Intervention for Chronic Illness (NICI)

Primary Purpose

Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Narrative Intervention for Chronic Illness-Heart Failure
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dx with Heart Failure, NYHA Class III and IV Have an email address and able to check email regularly Have a working phone number Between the ages of 18-89 years old Exclusion Criteria: Conflicting research study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NICI-HF

    Attention control

    Arm Description

    This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months.

    This arm will receive regular emails with information about heart failure for 3 months.

    Outcomes

    Primary Outcome Measures

    Personal Health Questionarire-8 item (PHQ8)
    The PHQ8 is a measurement of depression, found to be reliable for people living with heart failure.

    Secondary Outcome Measures

    Generalized Anxiety Disorder measurement- 7 item (GAD-7)
    The GAD7 is a measurement of anxiety found to be reliable for people living with chronic illnesses like heart failure.

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06097481
    Brief Title
    Narrative Intervention for Chronic Illness
    Acronym
    NICI
    Official Title
    The Narrative Intervention for Chronic Illness- Heart Failure (NICI-HF) Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    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
    The proposed study will test the NICI intervention. This study will gain insight into living with heart failure and learn if the NICI intervention is feasible and acceptable for people living with heart failure in both rural and urban locations. The study has two specific aims: Explore patterns and themes in illness narratives shared using thematic narrative inquiry to inform the tailoring content of the intervention (Phase 1). Establish the acceptability, satisfaction, and feasibility of an asynchronous narrative intervention for people living with HF in both rural and urban settings. Review trends and patterns in depression and anxiety outcomes in both rural and urban settings for efficacy. (Phase 2).
    Detailed Description
    This study will enroll people living with NYHA class III or IV heart failure. Participants will be randomized to the two arms. In arm 1, participants write illness narratives in response to a prompt given to them by a licensed mental health therapist through email. Each participant will receive tailored feedback and additional prompts to reflect on their narrative and explore their experience using narrative therapy techniques. In arm 2, participants will be encouraged to write about the illness experience and be offered handouts with information about heart failure. This will serve as an attention control. Emails will be sent biweekly for 3 months for each arm.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Study will have two arms, intervention and attention control arms.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Participants will not know if they are in the intervention or attention control arm. Statisticians will not know arm when assessing outcomes.
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NICI-HF
    Arm Type
    Experimental
    Arm Description
    This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months.
    Arm Title
    Attention control
    Arm Type
    Placebo Comparator
    Arm Description
    This arm will receive regular emails with information about heart failure for 3 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Narrative Intervention for Chronic Illness-Heart Failure
    Intervention Description
    The Narrative Intervention for Chronic Illness-Heart Failure includes narrative-based, strengths-based, solution-focused brief therapy, and Unitary Caring Science to improve depression (primary outcome) and anxiety (secondary outcome) for people living with heart failure.
    Primary Outcome Measure Information:
    Title
    Personal Health Questionarire-8 item (PHQ8)
    Description
    The PHQ8 is a measurement of depression, found to be reliable for people living with heart failure.
    Time Frame
    Administered at baseline, 3 months, and 6 months
    Secondary Outcome Measure Information:
    Title
    Generalized Anxiety Disorder measurement- 7 item (GAD-7)
    Description
    The GAD7 is a measurement of anxiety found to be reliable for people living with chronic illnesses like heart failure.
    Time Frame
    Administered at baseline, 3 months, and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Dx with Heart Failure, NYHA Class III and IV Have an email address and able to check email regularly Have a working phone number Between the ages of 18-89 years old Exclusion Criteria: Conflicting research study

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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