跳至主要内容
临床试验/NCT06988995
NCT06988995招募中不适用

Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers

University of Florida1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Self-compassion

研究概览

简要总结

Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation.

Over the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys.

Participants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member

排除标准

  • •Currently or in the past 3 months received psychotherapy or psychosocial or peer support; hospitalized for psychiatric reasons in the past 6 months; current, active suicidal thoughts or a reported suicide attempt within the past year; a current alcohol/substance use disorder that required immediate treatment; or a current or past thought disorder, psychosis, or unmanaged bipolar disorder; enrolled in another investigational research/clinical trial; toxic/negative dynamic between pt and caregiver; extended post-LVAD implantation course (i.e., more than 2 months in the hospital).

研究组 & 干预措施

Information

Active Comparator

干预措施: Information (Other)

Meeting

Experimental

干预措施: Meeting (Behavioral)

结局指标

主要结局

Self-compassion

时间窗: 2 months

Level of self-compassion a participant reports using the Self-Compassion Scale - Short Form (Raes et al., 2011). Scores range from 1-5.

QOL

时间窗: 2 months

Quality of Life will be measured using the 16 item Quality of Life Scale (Burckhardt et al., 1989). Scores range from 16-112, with higher scores indicating higher levels of quality of life.

次要结局

  • NYHA(2 months)
  • Cardiac Self-Efficacy(2 months)
  • General Self-Efficacy(2 months)
  • Illness Denial(2 months)
  • Perceived Stress Scale(2 months)
  • Caregiver Burden(2 months)
  • Acceptability & Feasibility of Intervention(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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