Supporting Health in Veterans With Heart Failure

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Florida State University
Study ID
NCT05839067
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Care-HF — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Heart Failure Self-care [ Time Frame: baseline ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Clinic - GainesvilleGainesvilleFlorida32608
Kimberly Phillips
[email protected]
VA Clinic - TogusTogusMaine04330
November Poulin
[email protected]
VA Clinic - DurhamDurhamNorth Carolina27705
Holly Christman
[email protected]
VA Clinic - ProvidenceProvidenceRhode Island02908
Jeannie Ursillo
[email protected]
Elizabeth Medbury
[email protected]

Find similar trials in Gainesville, FL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
VA Clinic - Gainesville· Gainesville, FLVA Clinic - Togus· Togus, MEVA Clinic - Durham· Durham, NCVA Clinic - Providence· Providence, RI

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