Heart Failure Clinical Trial

Supporting Health in Veterans With Heart Failure

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT05839067

Recruitment Status:

Recruiting

Sponsor:

Florida State University

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There are 4 Locations for this study

See Locations Near You

VA Clinic - Gainesville
Gainesville Florida, 32608, United States More Info
Kimberly Phillips
Contact
[email protected]
VA Clinic - Togus
Togus Maine, 04330, United States More Info
November Poulin
Contact
[email protected]
VA Clinic - Durham
Durham North Carolina, 27705, United States More Info
Holly Christman
Contact
[email protected]
VA Clinic - Providence
Providence Rhode Island, 02908, United States More Info
Jeannie Ursillo
Contact
[email protected]
Elizabeth Medbury
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT05839067

Recruitment Status:

Recruiting

Sponsor:


Florida State University

How clear is this clinincal trial information?

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