Heart FailurePhase 1/2NICI-HFNCT06097481
Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF)
A Phase 1/2 study testing Narrative Intervention for Chronic Illness-Heart Failure in people with Heart Failure and Heart Failure NYHA Class III, run by University of Colorado, Denver.
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- Narrative Intervention for Chronic Illness-Heart Failure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Conflicting research study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity
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.
Read the 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.
- Being tested
- Narrative Intervention for Chronic Illness-Heart Failure, Attention Control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Intervention for Chronic Illness-Heart FailureBehavioural
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 ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NICI-HF | Experimental | This arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months. Receives: Behavioral: Narrative Intervention for Chronic Illness-Heart Failure |
| Sham control | Placebo comparator | This arm will receive regular emails with information about heart failure for 3 months. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Administered at baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startSep 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will have two arms, intervention and sham control arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097481
- Sponsor's protocol ID
- 23-0436
- Acronym
- NICI-HF
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity
- ClinicalTrials.gov ID
- NCT06097481
- Acronym / sponsor ID
- NICI-HF / 23-0436
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Study will have two arms, intervention and sham control arms.
| Arm | Type | Receives |
|---|---|---|
| NICI-HF | Experimental | Behavioral: Narrative Intervention for Chronic Illness-Heart FailureThis arm will receive the NICI-HF intervention with regular emails from a therapist for 3 months. |
| Sham control | Placebo comparator | Other: Attention ControlThis arm will receive regular emails with information about heart failure for 3 months. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Conflicting research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Intervention for Chronic Illness-Heart FailureThe 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. | Behavioural | NICI-HF |
| Attention ControlAutomated 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. | Other | Sham control |
Primary outcome
Personal Health Questionnaire 9 item (PHQ9)
Time frame: Administered at baseline, 3 months, and 6 months
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.
1 secondary outcome
Generalized Anxiety Disorder measurement- 7 item (GAD-7)
Time frame: Administered at baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Narrative Intervention for Chronic Illness-Heart Failure in people with Heart Failure and Heart Failure NYHA Class III, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Johnson (3038420270, rachel.a.johnson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Health Questionnaire 9 item (PHQ9) (time frame: Administered at baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.