Clinical trial NCT05839067: Supporting Health in Veterans With Heart Failure
Official title: Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
problem-solving
Veterans
self-care
quality of life
depression
anxiety
stress
symptoms
resilience
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2023-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Heart Failure Self-care
timeFrame: baseline
measure: Heart Failure Self-care
timeFrame: 3-months
measure: Heart Failure Self-care
timeFrame: 6-months
measure: Heart Failure Self-care
timeFrame: 12-months
measure: Heart Failure Self-care
timeFrame: 18-months
measure: Heart Failure Symptoms
timeFrame: baseline
measure: Heart Failure Symptoms
timeFrame: 3-months
measure: Heart Failure Symptoms
timeFrame: 6-months
measure: Heart Failure Symptoms
timeFrame: 12-months
measure: Heart Failure Symptoms
timeFrame: 18-months
measure: Depression
timeFrame: baseline
measure: Depression
timeFrame: 3-months
measure: Depression
timeFrame: 6-months
measure: Depression
timeFrame: 12 months
measure: Depression
timeFrame: 18 months
measure: Anxiety
timeFrame: baseline
measure: Anxiety
timeFrame: 3-months
measure: Anxiety
timeFrame: 6-months
measure: Anxiety
timeFrame: 12-months
measure: Anxiety
timeFrame: 18-months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: baseline
measure: Health Related Quality of Life
timeFrame: 3-months
measure: Health Related Quality of Life
timeFrame: 6-months
measure: Health Related Quality of Life
timeFrame: 12-months
measure: Health Related Quality of Life
timeFrame: 18-months
measure: Healthcare Utilization
timeFrame: baseline
measure: Healthcare Utilization
timeFrame: 3-months
measure: Healthcare Utilization
timeFrame: 6-months
measure: Healthcare Utilization
timeFrame: 12-months
measure: Healthcare Utilization
timeFrame: 18-months
measure: Stress
timeFrame: baseline
measure: Stress
timeFrame: 3-months
measure: Stress
timeFrame: 6-months
measure: Stress
timeFrame: 12-months
measure: Stress
timeFrame: 18-months
measure: Resilience
timeFrame: baseline
measure: Resilience
timeFrame: 3-months
measure: Resilience
timeFrame: 6-months
measure: Resilience
timeFrame: 12-months
measure: Resilience
timeFrame: 18-months
measure: Coping
timeFrame: baseline
measure: Coping
timeFrame: 3-months
measure: Coping
timeFrame: 6-months
measure: Coping
timeFrame: 12-months
measure: Coping
timeFrame: 18-months
Other outcomes:
measure: Problem-Solving
timeFrame: baseline
measure: Problem-Solving
timeFrame: 3-months
measure: Problem-Solving
timeFrame: 6-months
measure: Problem-Solving
timeFrame: 12-months
measure: Problem-Solving
timeFrame: 18-months
measure: Social Support
timeFrame: baseline
Locations:
city: Gainesville
country: United States
facility: VA Clinic - Gainesville
state: Florida
city: Togus
country: United States
facility: VA Clinic - Togus
state: Maine
city: Durham
country: United States
facility: VA Clinic - Durham
state: North Carolina
city: Providence
country: United States
facility: VA Clinic - Providence
state: Rhode Island
Study officials:
affiliation: Florida State University College of Nursing
name: Lucinda J Graven, PhD
role: PRINCIPAL_INVESTIGATOR
References: