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

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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06097481
Acronym
NICI-HF
Enrollment
300
Registered
2023-10-24
Start date
2025-09-30
Completion date
2027-11-30
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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), Kansas City Cardiomyopathy Questionnaire (KCCQ), and the Self Care Heart Failure Index (SCHFI). T3 measurements include: PHQ9, GAD7, KCCQ, and SCHFI. Measurements at T6 include: PHQ9, GAD7, SCHFI, KCCQ, 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.

Interventions

BEHAVIORALNarrative 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.

OTHERAttention 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants will not know if they are in the intervention or sham control arm. Statisticians will not know arm when assessing outcomes.

Intervention model description

Study will have two arms, intervention and sham control arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Personal Health Questionnaire 9 item (PHQ9)Administered at baseline, 3 months, and 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder measurement- 7 item (GAD-7)Administered at baseline, 3 months, and 6 monthsThe 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.

Other

MeasureTime frameDescription
Self Care Heart Failure Index (SCHFI)Administered at baseline, 3 months, and 6 monthsThe 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.
Kansas City Cardiomyopathy Questionnaire (KCCQ)Administered at baseline, 3 months, and 6 monthsThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self reported heart failure severity measure. Scores range from 0-100: frequently summarized as 25-point ranges with 0 being very poor and 100 being excellent.

Contacts

Primary ContactRachel Johnson
rachel.a.johnson@cuanschutz.edu3038420270

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026