Recruiting

Heart Failure

Sponsor:

Florida State University

Code:

NCT05839067

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Care-HF

Study Details

Brief summary:

This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.

Conditions

Heart Failure

Study ID

NCT05839067

Start date

May 31, 2023

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 years of age or older
  • US Veteran
  • Diagnosed with heart failure (reduced or preserved ejection fraction)
  • Able to read, speak, and understand English
  • Reliable telephone access

Exclusion Criteria:

• History of cognitive dysfunction

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CARE-HF

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.

Interventions

Care-HF

Participants will be trained to use a 5-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems over 12-weeks. The core belief of TSPS is effective problem-solving requires a positive problem orientation (i.e., viewing problems as a challenge versus a threat) and elicits rational problem-solving versus avoidance or impulsivity/carelessness. Problem-solving follows from a positive problem orientation and involves accurate problem identification, generation of appropriate potential solutions, active decision-making, and solution implementation and evaluation. The goal of this intervention is to move participants toward a positive problem orientation and use of rational problem-solving strategies that support greater physical and mental health.

Primary outcome measure

  • Heart Failure Self-care [ Time Frame: baseline ]
  • Heart Failure Self-care [ Time Frame: 3-months ]
  • Heart Failure Self-care [ Time Frame: 6-months ]
  • Heart Failure Self-care [ Time Frame: 12-months ]
  • Heart Failure Self-care [ Time Frame: 18-months ]
  • Heart Failure Symptoms [ Time Frame: baseline ]
  • Heart Failure Symptoms [ Time Frame: 3-months ]
  • Heart Failure Symptoms [ Time Frame: 6-months ]
  • Heart Failure Symptoms [ Time Frame: 12-months ]
  • Heart Failure Symptoms [ Time Frame: 18-months ]
  • Depression [ Time Frame: baseline ]
  • Depression [ Time Frame: 3-months ]
  • Depression [ Time Frame: 6-months ]
  • Depression [ Time Frame: 12 months ]
  • Depression [ Time Frame: 18 months ]
  • Anxiety [ Time Frame: baseline ]
  • Anxiety [ Time Frame: 3-months ]
  • Anxiety [ Time Frame: 6-months ]
  • Anxiety [ Time Frame: 12-months ]
  • Anxiety [ Time Frame: 18-months ]

Central Contacts and Locations

Central contacts

Lucinda J Graven, PhD

850-644-5601lgraven@fsu.edu

Locations

VA Clinic - Gainesville

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Kimberly Phillips

Kimberly.Phillips1@va.gov

VA Clinic - Togus

Recruiting

Togus, Maine, United States, 04330

Contacts

November Poulin

November.Poulin@va.gov

VA Clinic - Durham

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Holly Christman

Holly.Christman@va.gov

VA Clinic - Providence

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Jeannie Ursillo

Jeannie.Ursillo@va.gov

Elizabeth Medbury

Elizabeth.Medbury@va.gov

More Information

Sponsor

Florida State University

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • heart failure
  • problem-solving
  • Veterans
  • self-care
  • quality of life
  • depression
  • anxiety
  • stress
  • symptoms
  • resilience

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Florida State University on 2025-11-13.