Clinical trial NCT06097481: Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF)
Official title: Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study will have two arms, intervention and sham control arms.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Personal Health Questionnaire 9 item (PHQ9)
timeFrame: Administered at baseline, 3 months, and 6 months
Secondary outcomes:
measure: Generalized Anxiety Disorder measurement- 7 item (GAD-7)
timeFrame: Administered at baseline, 3 months, and 6 months
Other outcomes:
measure: Self Care Heart Failure Index (SCHFI)
timeFrame: Administered at baseline, 3 months, and 6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Administered at baseline, 3 months, and 6 months
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