跳至主要内容
临床试验/NCT05839067
NCT05839067招募中不适用

Supporting Physical & Mental Health in Rural Veterans With Heart Failure (CARE-HF)

Florida State University8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
8
主要终点
Heart Failure Self-care

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • History of cognitive dysfunction

结局指标

主要结局

Heart Failure Self-care

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Health Related Quality of Life(18-months)
  • Healthcare Utilization(18-months)
  • Resilience(18-months)
  • Coping(18-months)
  • Stress(18-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucinda Graven

Associate Professor

Florida State University

研究点 (8)

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