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
About this trial
This is an interventional supportive care trial for Heart Failure
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
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
NCT ID
NCT06097481
First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
University of Colorado, Denver
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
Narrative Intervention for Chronic Illness
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