Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839067
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-04-10
Brief Title:
Supporting Health in Veterans With Heart Failure
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Supporting Physical Mental Health in Rural Veterans With Heart Failure CARE-HF
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE-HF
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 ie 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 025 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 72 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 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 ie 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 025 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 72 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None