Heart FailureCARE-HFNCT05839067
Supporting Health in Veterans With Heart Failure
A study testing Care-HF in people with Heart Failure, run by Florida State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Care-HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 May 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of cognitive dysfunction
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Clinic - Durham
Durham, North Carolina, 27705
VA Clinic - Gainesville
Gainesville, Florida, 32608
VA Clinic - Providence
Providence, Rhode Island, 02908
VA Clinic - Togus
Togus, Maine, 04330
About this study
Official title: Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)
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.
Read the detailed description
The long-term goal of this research is to support physical and mental health of Veterans with heart failure and enrich rehabilitation and independent living by enhancing disease self-management and coping processes in the home.
Study objectives include: (1) Evaluate the feasibility of recruitment and enrollment processes, attrition, and program acceptability in a sample of Veterans with HF; (2) Evaluate program effectiveness on study outcomes (i.e., self-care, symptoms, depression, anxiety, quality of life, stress, resilience, coping, and healthcare utilization); and (3) examine the sustainability of intervention effect.
This study will be guided by quantitative inquiry and include a single-group, repeated measures design. A sample size of 100 participants is desired based on a power analysis for repeated measures ANOVA with 5 time points, alpha level of .05, a medium effect size (f = 0.25), and 80% power, plus oversampling for potential attrition (20%). Following verbal informed consent via telephone, all participants will complete baseline data collection which will include a Sociodemographic and Clinical Survey, the Interpersonal Support Evaluation List - 12 (ISEL), the Social Problem-Solving Inventory Revised-Short (SPSIRs), the Self-care of Heart Failure Index (SCHFI, v 7.2), the Heart Failure Symptom Survey (HFSS), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder (GAD) scale, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), the Perceived Stress Scale (PSS), the 5x5 Resilience Scale, the Brief COPE, and a healthcare utilization survey.
All participants will participate in a tailored problem-solving intervention designed to help manage heart failure-related problems experienced in the home over 12 weeks (Weeks 1-4, 6, 8, 10, 12). Follow-up data collection will occur at 3-months (post-intervention) and 6-, 12-, and 18-months. Quantitative data on study variables will be collected using the following self-report surveys: SPSIRs, SCHFI, HFSS, PHQ-9, GAD, MLHFQ, PSS, 5x5 Resilience scale, Brief COPE, and healthcare utilization. All data will be collected by a trained research assistant who will collect study data over the telephone and mark participants answers on a computerized data spreadsheet. Possible treatment effectiveness on heart failure self-care, heart failure symptoms, healthcare utilization, depression, anxiety, quality of life, stress, resilience, coping, and differences among subgroups over the study period will be examined using multilevel modeling.
- Conditions
- Heart Failure
- Being tested
- Care-HF
- Keywords
- heart failure, problem-solving, Veterans, self-care, quality of life, depression, anxiety, stress, symptoms, resilience
- Medical subject headings
- Heart Failure, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care-HFBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care-HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18-months
Secondary outcomes (25)
Health Related Quality of Life
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: baseline
Health Related Quality of Life
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: 3-months
Health Related Quality of Life
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: 6-months
Health Related Quality of Life
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: 12-months
Health Related Quality of Life
Quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life
Measured: 18-months
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Measured: baseline
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Measured: 3-months
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Measured: 6-months
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Measured: 12-months
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Measured: 18-months
Stress
The Perceived Stress Scale (PSS) will measure perceptions of stress and anger. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress.
Measured: baseline
Stress
The Perceived Stress Scale (PSS) will measure perceptions of stress and anger. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress
Measured: 3-months
Stress
The Perceived Stress Scale (PSS) will measure perceptions of stress and anger. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress
Measured: 6-months
Stress
The Perceived Stress Scale (PSS) will measure perceptions of stress and anger. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress
Measured: 12-months
Stress
The Perceived Stress Scale (PSS) will measure perceptions of stress and anger. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress
Measured: 18-months
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Measured: baseline
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Measured: 3-months
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Measured: 6-months
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Measured: 12-months
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Measured: 18-months
Coping
The Brief COPE will measure the use coping strategies. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale.
Measured: baseline
Coping
The Brief COPE will measure the use coping strategies. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale.
Measured: 3-months
Coping
The Brief COPE will measure the use coping strategies. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale.
Measured: 6-months
Coping
The Brief COPE will measure the use coping strategies. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale.
Measured: 12-months
Coping
The Brief COPE will measure the use coping strategies. Each of the 14 scales is comprised of 2 items; total scores on each scale range from 2 (minimum) to 8 (maximum). Higher scores indicate increased utilization of that specific coping strategy. Total scores on each of the scales are calculated by summing the appropriate items for each scale.
Measured: 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start31 May 2023
- Primary completion30 Sep 2025
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 100 participants will be trained to use a 5-step theoretically driven problem-solving process to manage heart failure problems experienced in the home.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Lucinda Graven, Florida State University
- Investigators
- Lucinda J Graven, PhD, Principal investigator, Florida State University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839067
- Sponsor's protocol ID
- 00003764
- Acronym
- CARE-HF
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other investigators.
Publications
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.
PubMed 40138689
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)
- ClinicalTrials.gov ID
- NCT05839067
- Acronym / sponsor ID
- CARE-HF / 00003764
- Conditions
- Heart Failure
- Keywords
- heart failure, problem-solving, Veterans, self-care, quality of life, depression, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 31 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long-term goal of this research is to support physical and mental health of Veterans with heart failure and enrich rehabilitation and independent living by enhancing disease self-management and coping processes in the home.
Study objectives include: (1) Evaluate the feasibility of recruitment and enrollment processes, attrition, and program acceptability in a sample of Veterans with HF; (2) Evaluate program effectiveness on study outcomes (i.e., self-care, symptoms, depression, anxiety, quality of life, stress, resilience, coping, and healthcare utilization); and (3) examine the sustainability of intervention effect.
This study will be guided by quantitative inquiry and include a single-group, repeated measures design. A sample size of 100 participants is desired based on a power analysis for repeated measures ANOVA with 5 time points, alpha level of .05, a medium effect size (f = 0.25), and 80% power, plus oversampling for potential attrition (20%). Following verbal informed consent via telephone, all participants will complete baseline data collection which will include a Sociodemographic and Clinical Survey, the Interpersonal Support Evaluation List - 12 (ISEL), the Social Problem-Solving Inventory Revised-Short (SPSIRs), the Self-care of Heart Failure Index (SCHFI, v 7.2), the Heart Failure Symptom Survey (HFSS), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder (GAD) scale, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), the Perceived Stress Scale (PSS), the 5x5 Resilience Scale, the Brief COPE, and a healthcare utilization survey.
All participants will participate in a tailored problem-solving intervention designed to help manage heart failure-related problems experienced in the home over 12 weeks (Weeks 1-4, 6, 8, 10, 12). Follow-up data collection will occur at 3-months (post-intervention) and 6-, 12-, and 18-months. Quantitative data on study variables will be collected using the following self-report surveys: SPSIRs, SCHFI, HFSS, PHQ-9, GAD, MLHFQ, PSS, 5x5 Resilience scale, Brief COPE, and healthcare utilization. All data will be collected by a trained research assistant who will collect study data over the telephone and mark participants answers on a computerized data spreadsheet. Possible treatment effectiveness on heart failure self-care, heart failure symptoms, healthcare utilization, depression, anxiety, quality of life, stress, resilience, coping, and differences among subgroups over the study period will be examined using multilevel modeling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 100 participants will be trained to use a 5-step theoretically driven problem-solving process to manage heart failure problems experienced in the home.
| Arm | Type | Receives |
|---|---|---|
| CARE-HF | Experimental | Behavioral: Care-HFThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- History of cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care-HFParticipants 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. | Behavioural | CARE-HF |
Primary outcome
Heart Failure Self-care
Time frame: baseline
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.
Heart Failure Self-care
Time frame: 3-months
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.
Heart Failure Self-care
Time frame: 6-months
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.
Heart Failure Self-care
Time frame: 12-months
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.
Heart Failure Self-care
Time frame: 18-months
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.
Heart Failure Symptoms
Time frame: baseline
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.
Heart Failure Symptoms
Time frame: 3-months
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.
Heart Failure Symptoms
Time frame: 6-months
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.
Heart Failure Symptoms
Time frame: 12-months
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.
Heart Failure Symptoms
Time frame: 18-months
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.
Depression
Time frame: baseline
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.
Depression
Time frame: 3-months
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.
Depression
Time frame: 6-months
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.
Depression
Time frame: 12 months
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.
Depression
Time frame: 18 months
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.
Anxiety
Time frame: baseline
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.
Anxiety
Time frame: 3-months
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.
Anxiety
Time frame: 6-months
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.
Anxiety
Time frame: 12-months
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.
Anxiety
Time frame: 18-months
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.
25 secondary outcomes
Health Related Quality of Life
Time frame: baseline
Health Related Quality of Life
Time frame: 3-months
Health Related Quality of Life
Time frame: 6-months
Health Related Quality of Life
Time frame: 12-months
Health Related Quality of Life
Time frame: 18-months
Healthcare Utilization
Time frame: baseline
Healthcare Utilization
Time frame: 3-months
Healthcare Utilization
Time frame: 6-months
Healthcare Utilization
Time frame: 12-months
Healthcare Utilization
Time frame: 18-months
Stress
Time frame: baseline
Stress
Time frame: 3-months
Stress
Time frame: 6-months
Stress
Time frame: 12-months
Stress
Time frame: 18-months
Resilience
Time frame: baseline
Resilience
Time frame: 3-months
Resilience
Time frame: 6-months
Resilience
Time frame: 12-months
Resilience
Time frame: 18-months
Coping
Time frame: baseline
Coping
Time frame: 3-months
Coping
Time frame: 6-months
Coping
Time frame: 12-months
Coping
Time frame: 18-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 40138689Graven 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.
- Individual participant dataSharing planned: No. No IPD will be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucinda J Graven, PhD principal investigator
Florida State University College of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care-HF in people with Heart Failure, run by Florida State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Self-care (time frame: baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.