Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF) (NICI-HF)

Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity

The Narrative Intervention for Chronic Illness-Heart Failure (NICI-HF) offers an asynchronous interactive text behavioral health intervention to advance behavioral health equity by facilitating access to care for people adjusting to living with heart failure (HF). The proposed study will recruit up to 70 people living with heart failure. This study will gain insight into living with heart failure and learn if the narrative-based intervention is feasible and acceptable for people living with heart failure. The study has two specific aims:

Aim 1: Evaluate the effects of NICI-HF intervention on standard behavioral outcomes. The study investigators will review depression with the Personal Health Questionnaire-9 (primary) and anxiety with the General Anxiety Disorder-7 (secondary) outcomes, and explore self-care with the Self Care for Heart Failure Index by comparing the sham control (n=30) and NICI-HF intervention (n=30) groups at baseline, three months, and six months.

Aim 2: Refine NICI-HF for feasibility and acceptability to support HF self-care and burdensome symptom management and to increase behavioral health equity by improving proximity to services. The study investigators will use the RE-AIM21 framework to tailor the intervention for HF using qualitative semi-structured interviews and mixed methods analysis. The study investigators will refine and manualize the intervention for future R01 testing across chronic illnesses with diverse and marginalized populations and service delivery models.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Heart Failure NYHA Class III; Heart Failure NYHA Class IV
• Intervention / Treatment: Behavioral: Narrative Intervention for Chronic Illness-Heart Failure; Other: Attention Control

Detailed Description

The Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity study is a NIH Intervention Stage 1B intervention study design with randomization into two arms: a sham control (SC) and an intervention arm (IA). The study investigators will be recruiting up to 64 participants adjusting to living with heart failure. All participants will be randomized to the SC or IA arms (1:1 randomization). All participants will be asked to complete measurements at baseline (T0), three months (T3), and six months (T6). Measurements at T0 include demographic information, Personal Health Questionnaire-9 item (PHQ9), General Anxiety Disorder-7 item (GAD7), and the Self Care Heart Failure Index (SCHFI). T3 measurements include: PHQ9, GAD7, and SCHFI. Measurements at T6 include: PHQ9, GAD7, SCHFI, and self-reported access to care and healthcare utilization. Measurements will be administered by email link using REDCap (an online database administered by the University of Colorado).

Intervention and sham control groups will receive biweekly text response prompts. The IA will have tailored responses crafted by the social work psychotherapists. The SC group will not have feedback or tailored responses.

Study participants who complete Week 8 will also be asked to participate in a semi-structured interview at T3. The study investigators will integrate both quantitative and qualitative results as a convergent mixed methods analysis study. In the mixed analyses, The study investigators will pay attention to points of integration in the qualitative subsample of the population, patterns of behavioral outcome scores, context, geolocation characteristics, access to care experience; and frequency of self-schema, world-schema, and self-care of illness compared across aims.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rachel Johnson; Phone Number: 3038420270; Email: rachel.a.johnson@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICI-HF; This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months.	Behavioral: Narrative Intervention for Chronic Illness-Heart Failure; 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.
Placebo Comparator: Attention control; This arm will receive regular emails with information about heart failure for 3 months.	Other: Attention Control; Automated emails at similar time points to the intervention will be sent to participants in this arm. Emails will ask participants to reflect on their illness experience and offer general information about heart failure using standardized handouts from the American Heart Association and Up-To-Date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Health Questionnaire 9 item (PHQ9)	The Personal Health Questionnaire 9 item (PHQ9) is a measurement of depression, found to be reliable for people living with heart failure. Scores range from 0-27, with higher scores indicating higher depression levels.	Administered at baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder measurement- 7 item (GAD-7)	The Generalized Anxiety Disorder measurement- 7 item (GAD-7) is a measurement of anxiety found to be reliable for people living with chronic illnesses like heart failure. Scores range from 0-21 with higher scores indicating higher levels of anxiety.	Administered at baseline, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Care Heart Failure Index (SCHFI)	The Self Care Heart Failure Index (SCHFI) is a measurement of heart failure self-care and has been found to be reliable for people living with heart failure. Scores vary from 0-100. A score of 70 or greater can be used as the cut-point to judge self-care adequacy, although evidence is provided that benefit occurs at even lower levels of self-care.	Administered at baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Chronic Disease
• Other Study ID Numbers: 23-0436

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