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

NCT06097481 | Not Yet Recruiting Phase 1

• 1 other identifier: 23-0436
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 standard implementation domains 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.

Conditions

Heart Failure; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Generalized Anxiety Disorder measurement- 7 item (GAD-7)

  Administered at baseline, 3 months, and 6 months

Other Outcomes (2)

• Self Care Heart Failure Index (SCHFI)

  Administered at baseline, 3 months, and 6 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Administered at baseline, 3 months, and 6 months

Study Arms (2)

NICI-HF

EXPERIMENTAL

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

Sham control

PLACEBO COMPARATOR

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

Other: Attention Control

Interventions

Narrative Intervention for Chronic Illness-Heart Failure BEHAVIORAL

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.

NICI-HF

Attention Control OTHER

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.

Sham control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Conflicting research study

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Rachel Johnson

CONTACT

3038420270; rachel.a.johnson@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know if they are in the intervention or sham control arm. Statisticians will not know arm when assessing outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study will have two arms, intervention and sham control arms.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share