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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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Depression

Heart Failure Self-care

+1 more

Secondary study objectives

Coping

Health Related Quality of Life

Healthcare Utilization

+2 more

Other study objectives

Problem-Solving

Social Support

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met