Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06097481 |
Other study ID # |
23-0436 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 1/Phase 2
|
First received |
|
Last updated |
|
Start date |
September 2024 |
Est. completion date |
November 2026 |
Study information
Verified date |
May 2024 |
Source |
University of Colorado, Denver |
Contact |
Rachel Johnson |
Phone |
3038420270 |
Email |
rachel.a.johnson[@]cuanschutz.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 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.
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.