Supporting Health in Veterans With Heart Failure

NCT05839067 | Recruiting

• 1 other identifier: 00003764
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (20)

• Heart Failure Self-care

  Self-care maintenance, management, and confidence will be self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 7.0. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.

  baseline

• Heart Failure Self-care

  Self-care maintenance, management, and confidence will be self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 7.0. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.

  3-months

• Heart Failure Self-care

  Self-care maintenance, management, and confidence will be self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 7.0. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.

  6-months

• Heart Failure Self-care

  Self-care maintenance, management, and confidence will be self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 7.0. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.

  12-months

• Heart Failure Self-care

  Self-care maintenance, management, and confidence will be self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 7.0. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.

  18-months

• Heart Failure Symptoms

  Symptoms of HF will be assessed using the Heart Failure Symptom Survey (HFSS). This survey contains 14 symptoms commonly experienced by those with HF. Participants rate each symptom according to 4 domains (i.e., frequency, severity, interference with physical activity, and interference with enjoyment of life) based upon the last 7 days. Higher scores indicate more of the respective domain in relation to the particular symptom.

  baseline

• Heart Failure Symptoms

  Symptoms of HF will be assessed using the Heart Failure Symptom Survey (HFSS). This survey contains 14 symptoms commonly experienced by those with HF. Participants rate each symptom according to 4 domains (i.e., frequency, severity, interference with physical activity, and interference with enjoyment of life) based upon the last 7 days. Higher scores indicate more of the respective domain in relation to the particular symptom.

  3-months

• Heart Failure Symptoms

  Symptoms of HF will be assessed using the Heart Failure Symptom Survey (HFSS). This survey contains 14 symptoms commonly experienced by those with HF. Participants rate each symptom according to 4 domains (i.e., frequency, severity, interference with physical activity, and interference with enjoyment of life) based upon the last 7 days. Higher scores indicate more of the respective domain in relation to the particular symptom.

  6-months

• Heart Failure Symptoms

  Symptoms of HF will be assessed using the Heart Failure Symptom Survey (HFSS). This survey contains 14 symptoms commonly experienced by those with HF. Participants rate each symptom according to 4 domains (i.e., frequency, severity, interference with physical activity, and interference with enjoyment of life) based upon the last 7 days. Higher scores indicate more of the respective domain in relation to the particular symptom.

  12-months

• Heart Failure Symptoms

  Symptoms of HF will be assessed using the Heart Failure Symptom Survey (HFSS). This survey contains 14 symptoms commonly experienced by those with HF. Participants rate each symptom according to 4 domains (i.e., frequency, severity, interference with physical activity, and interference with enjoyment of life) based upon the last 7 days. Higher scores indicate more of the respective domain in relation to the particular symptom.

  18-months

• Depression

  Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  baseline

• Depression

  Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  3-months

• Depression

  Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  6-months

• Depression

  Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  12 months

• Depression

  Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  18 months

• Anxiety

  Anxiety will be measured using the Generalized Anxiety Disorder (GAD) scale. Scores are totaled and indicate the level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  baseline

• Anxiety

  Anxiety will be measured using the Generalized Anxiety Disorder (GAD) scale. Scores are totaled and indicate the level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  3-months

• Anxiety

  Anxiety will be measured using the Generalized Anxiety Disorder (GAD) scale. Scores are totaled and indicate the level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  6-months

• Anxiety

  Anxiety will be measured using the Generalized Anxiety Disorder (GAD) scale. Scores are totaled and indicate the level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  12-months

• Anxiety

  Anxiety will be measured using the Generalized Anxiety Disorder (GAD) scale. Scores are totaled and indicate the level of anxiety. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

  18-months

Secondary Outcomes (25)

• Health Related Quality of Life

  baseline

• Health Related Quality of Life

  3-months

• Health Related Quality of Life

  6-months

• Health Related Quality of Life

  12-months

• Health Related Quality of Life

  18-months

Other Outcomes (6)

• Problem-Solving

  baseline

• Problem-Solving

  3-months

• Problem-Solving

  6-months

Study Arms (1)

CARE-HF

EXPERIMENTAL

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.

Behavioral: Care-HF

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.

CARE-HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of cognitive dysfunction

Sponsors & Collaborators

• Florida State University: lead
• US Department of Veterans Affairs: collaborator

Study Sites (4)

VA Clinic - Gainesville

Gainesville, Florida, 32608, United States

RECRUITING

VA Clinic - Togus

Togus, Maine, 04330, United States

RECRUITING

VA Clinic - Durham

Durham, North Carolina, 27705, United States

RECRUITING

VA Clinic - Providence

Providence, Rhode Island, 02908, United States

RECRUITING

Related Publications (1)

• Graven LJ, Abbott L, Hodgkins JV, Ledermann T, Howren MB. Supporting Physical and Mental Health in Rural Veterans Living With Heart Failure: Protocol for a Nurse-Led Telephone Intervention Study. JMIR Res Protoc. 2025 Mar 26;14:e63498. doi: 10.2196/63498.

  PMID: 40138689 DERIVED

MeSH Terms

Conditions

Heart Failure; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Lucinda J Graven, PhD

  Florida State University College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucinda J Graven, PhD

CONTACT

850-644-5601; lgraven@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 100 participants will be trained to use a 5-step theoretically driven problem-solving process to manage heart failure problems experienced in the home.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 3, 2023
• Study Start: May 31, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)