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Behavioral Intervention

Nurse-Led Phone Support for Heart Failure (CARE-HF Trial)

N/A
Recruiting
Led By Lucinda J Graven, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with heart failure (reduced or preserved ejection fraction)
Age 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-months
Awards & highlights

CARE-HF Trial Summary

This trial tests a phone-based program, run by nurses, to improve physical and mental health in Veterans with heart failure. It's done in the US and monitored for 18 months.

Who is the study for?
This trial is for US Veterans aged 18 or older who have been diagnosed with heart failure, regardless of the type. Participants must be able to read, speak, and understand English and have reliable telephone access. Those with a history of cognitive dysfunction cannot join.Check my eligibility
What is being tested?
The study tests a tailored telehealth program called Care-HF designed for veterans with heart failure. It involves working with a nurse over the phone for 12 weeks, including eight sessions aimed at improving physical and mental health.See study design
What are the potential side effects?
Since this intervention is non-medical and involves only telephone-based problem-solving sessions, there are no direct medical side effects associated with drugs or procedures.

CARE-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with heart failure.
Select...
I am 18 years old or older.

CARE-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Depression
Heart Failure Self-care
+1 more
Secondary outcome measures
Coping
Health Related Quality of Life
Healthcare Utilization
+2 more
Other outcome measures
Problem-Solving
Social Support

CARE-HF Trial Design

1Treatment groups
Experimental Treatment
Group I: CARE-HFExperimental Treatment1 Intervention
The problem-solving intervention will be led by a registered nurse. Participants will receive a program manual containing examples of common HF-related problems experienced by heart failure patients and suggested management strategies, with some strategies tailored to the rural sociocultural context. The nurse will lead participants in a card sorting task intended to help participants prioritize current HF-related problems and will guide participants in developing management strategies for the highest priority problem(s). Participants will utilize these strategies until the next session at which time the nurse will guide participants in evaluating the effectiveness of chosen strategies. The iterative process then begins again. Participants will receive 7 follow-up telephone sessions with the nurse. In the intervention, the nurse will focus on problems related to self-care, disease management, mental health, and quality of life, including those specific to the rural population.

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,658 Total Patients Enrolled
2 Trials studying Heart Failure
200 Patients Enrolled for Heart Failure
US Department of Veterans AffairsFED
868 Previous Clinical Trials
487,790 Total Patients Enrolled
30 Trials studying Heart Failure
10,718 Patients Enrolled for Heart Failure
Lucinda J Graven, PhDPrincipal InvestigatorFlorida State University College of Nursing

Media Library

Care-HF (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05839067 — N/A
Heart Failure Research Study Groups: CARE-HF
Heart Failure Clinical Trial 2023: Care-HF Highlights & Side Effects. Trial Name: NCT05839067 — N/A
Care-HF (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05839067 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this trial?

"According to the data hosted on clinicaltrials.gov, this trial is still recruiting participants. The initial posting date was April 10th 2023 and the page has had its most recent edit made on May 1st 2023."

Answered by AI

How many healthcare settings are conducting this experiment?

"Currently, 4 clinical sites are running this trial. Three of them can be found in Togus, Durham and Providence while the fourth is located in another city. To reduce travel costs, participants should choose a site that is closest to them."

Answered by AI

What objectives are researchers striving to achieve with this clinical trial?

"This 18-month medical trial aims to evaluate Heart failure Symptoms as its primary outcome. Additionally, Healthcare Utilization, Stress (as measured by the Perceived Stress Scale), and Resilience (measured via the Five-by-Five Resilience Scale) will be secondary outcomes of interest."

Answered by AI

How many individuals are presently being recruited to participate in this clinical trial?

"Affirmative; clinicaltrials.gov has records that attest to the current recruitment of patients for this trial, which was first posted on April 10th 2023. The study is seeking 100 participants from 4 medical sites and the information was last updated in May 1st 2023."

Answered by AI

Who else is applying?

What site did they apply to?
VA Clinic - Providence
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Supporting Health in Veterans With Heart Failure
Lucinda Graven 2023. "Supporting Health in Veterans With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839067.
All > Heart Failure With Preserved Ejection Fraction > Anxiety
~59 spots leftby Sep 2025
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