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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Conflicting research study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Attention Control

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: NICI-HFExperimental treatment 1 intervention
Group B: Sham controlPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Administered at baseline, 3 months, and 6 months

Secondary outcomes

1

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

The 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.

Time frame
Administered at baseline, 3 months, and 6 months

Other outcomes

1

Self Care Heart Failure Index (SCHFI)

The 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.

Time frame
Administered at baseline, 3 months, and 6 months
2

Kansas City Cardiomyopathy Questionnaire (KCCQ)

The 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.

Time frame
Administered at baseline, 3 months, and 6 months

Locations

This trial has no locations.

Sponsors and contacts

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