NCT06097481Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Heart failure
- NCT number
- NCT06097481
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 300
- From 1 Sept 2025 to the primary completion date, 30 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Conflicting research study
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.