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Supporting Health in Veterans With Heart Failure (CARE-HF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care-HF
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, problem-solving, Veterans, self-care, quality of life, depression, anxiety, stress, symptoms, resilience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Clinic - GainesvilleRecruiting
  • VA Clinic - TogusRecruiting
  • VA Clinic - DurhamRecruiting
  • VA Clinic - ProvidenceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CARE-HF

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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
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
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
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Healthcare Utilization
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
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.
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
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
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
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
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Resilience
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
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.
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.
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.
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.
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.

Full Information

First Posted
April 10, 2023
Last Updated
May 1, 2023
Sponsor
Florida State University
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT05839067
Brief Title
Supporting Health in Veterans With Heart Failure
Acronym
CARE-HF
Official Title
Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, problem-solving, Veterans, self-care, quality of life, depression, anxiety, stress, symptoms, resilience

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CARE-HF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Care-HF
Intervention Description
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 Information:
Title
Heart Failure Self-care
Description
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.
Time Frame
baseline
Title
Heart Failure Self-care
Description
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.
Time Frame
3-months
Title
Heart Failure Self-care
Description
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.
Time Frame
6-months
Title
Heart Failure Self-care
Description
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.
Time Frame
12-months
Title
Heart Failure Self-care
Description
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.
Time Frame
18-months
Title
Heart Failure Symptoms
Description
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.
Time Frame
baseline
Title
Heart Failure Symptoms
Description
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.
Time Frame
3-months
Title
Heart Failure Symptoms
Description
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.
Time Frame
6-months
Title
Heart Failure Symptoms
Description
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.
Time Frame
12-months
Title
Heart Failure Symptoms
Description
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.
Time Frame
18-months
Title
Depression
Description
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.
Time Frame
baseline
Title
Depression
Description
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.
Time Frame
3-months
Title
Depression
Description
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.
Time Frame
6-months
Title
Depression
Description
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.
Time Frame
12 months
Title
Depression
Description
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.
Time Frame
18 months
Title
Anxiety
Description
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.
Time Frame
baseline
Title
Anxiety
Description
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.
Time Frame
3-months
Title
Anxiety
Description
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.
Time Frame
6-months
Title
Anxiety
Description
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.
Time Frame
12-months
Title
Anxiety
Description
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.
Time Frame
18-months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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
Time Frame
baseline
Title
Health Related Quality of Life
Description
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
Time Frame
3-months
Title
Health Related Quality of Life
Description
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
Time Frame
6-months
Title
Health Related Quality of Life
Description
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
Time Frame
12-months
Title
Health Related Quality of Life
Description
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
Time Frame
18-months
Title
Healthcare Utilization
Description
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Time Frame
baseline
Title
Healthcare Utilization
Description
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Time Frame
3-months
Title
Healthcare Utilization
Description
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Time Frame
6-months
Title
Healthcare Utilization
Description
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Time Frame
12-months
Title
Healthcare Utilization
Description
Healthcare utilization was determined by the frequency of emergency department visits and readmissions for HF and assessed via self-report.
Time Frame
18-months
Title
Stress
Description
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.
Time Frame
baseline
Title
Stress
Description
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
Time Frame
3-months
Title
Stress
Description
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
Time Frame
6-months
Title
Stress
Description
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
Time Frame
12-months
Title
Stress
Description
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
Time Frame
18-months
Title
Resilience
Description
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Time Frame
baseline
Title
Resilience
Description
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Time Frame
3-months
Title
Resilience
Description
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Time Frame
6-months
Title
Resilience
Description
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Time Frame
12-months
Title
Resilience
Description
The Five-by-Five Resilience Scale will measure aspects of resilience. Higher scores indicate more resilience.
Time Frame
18-months
Title
Coping
Description
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.
Time Frame
baseline
Title
Coping
Description
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.
Time Frame
3-months
Title
Coping
Description
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.
Time Frame
6-months
Title
Coping
Description
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.
Time Frame
12-months
Title
Coping
Description
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.
Time Frame
18-months
Other Pre-specified Outcome Measures:
Title
Problem-Solving
Description
Problem-solving was self-reported and assessed using the Social Problem-Solving Inventory Revised (SPSIR) which measures problem orientation and problem-solving style. In addition to a total score, there are 5 sub-scales: positive problem orientation, negative problem orientation, rational problem-solving, impulsivity/carelessness, and avoidance style. Higher scores on each sub-scale suggest more of the problem-solving characteristic. Higher total scores suggest more adaptive problem-solving, while lower scores indicate more maladaptive problem-solving.
Time Frame
baseline
Title
Problem-Solving
Description
Problem-solving was self-reported and assessed using the Social Problem-Solving Inventory Revised (SPSIR) which measures problem orientation and problem-solving style. In addition to a total score, there are 5 sub-scales: positive problem orientation, negative problem orientation, rational problem-solving, impulsivity/carelessness, and avoidance style. Higher scores on each sub-scale suggest more of the problem-solving characteristic. Higher total scores suggest more adaptive problem-solving, while lower scores indicate more maladaptive problem-solving.
Time Frame
3-months
Title
Problem-Solving
Description
Problem-solving was self-reported and assessed using the Social Problem-Solving Inventory Revised (SPSIR) which measures problem orientation and problem-solving style. In addition to a total score, there are 5 sub-scales: positive problem orientation, negative problem orientation, rational problem-solving, impulsivity/carelessness, and avoidance style. Higher scores on each sub-scale suggest more of the problem-solving characteristic. Higher total scores suggest more adaptive problem-solving, while lower scores indicate more maladaptive problem-solving.
Time Frame
6-months
Title
Problem-Solving
Description
Problem-solving was self-reported and assessed using the Social Problem-Solving Inventory Revised (SPSIR) which measures problem orientation and problem-solving style. In addition to a total score, there are 5 sub-scales: positive problem orientation, negative problem orientation, rational problem-solving, impulsivity/carelessness, and avoidance style. Higher scores on each sub-scale suggest more of the problem-solving characteristic. Higher total scores suggest more adaptive problem-solving, while lower scores indicate more maladaptive problem-solving.
Time Frame
12-months
Title
Problem-Solving
Description
Problem-solving was self-reported and assessed using the Social Problem-Solving Inventory Revised (SPSIR) which measures problem orientation and problem-solving style. In addition to a total score, there are 5 sub-scales: positive problem orientation, negative problem orientation, rational problem-solving, impulsivity/carelessness, and avoidance style. Higher scores on each sub-scale suggest more of the problem-solving characteristic. Higher total scores suggest more adaptive problem-solving, while lower scores indicate more maladaptive problem-solving.
Time Frame
18-months
Title
Social Support
Description
Social support was self-reported and assessed using the Interpersonal Support and Evaluation List - 12 (ISEL-12) which measures perceived belonging, tangible, and appraisal support. Scores range from 0-36, with higher scores suggesting a higher perception of available support.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucinda J Graven, PhD
Phone
850-644-5601
Email
lgraven@fsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucinda J Graven, PhD
Organizational Affiliation
Florida State University College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Clinic - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Phillips
Email
Kimberly.Phillips1@va.gov
Facility Name
VA Clinic - Togus
City
Togus
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
November Poulin
Email
November.Poulin@va.gov
Facility Name
VA Clinic - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Christman
Email
Holly.Christman@va.gov
Facility Name
VA Clinic - Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannie Ursillo
Email
Jeannie.Ursillo@va.gov
First Name & Middle Initial & Last Name & Degree
Elizabeth Medbury
Email
Elizabeth.Medbury@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other investigators.

Learn more about this trial

Supporting Health in Veterans With Heart Failure

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