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临床试验/NCT06731166
NCT06731166已完成不适用

Effectiveness of Video Monitoring and Care Transition for Heart Failure Patients (EVIT-HF): Randomized Clinical Trial

Federal University of Uberlandia1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure

研究概览

简要总结

The goal of this clinical trial is to measure the effectiveness of video monitoring associated with the transition of care for patients with heart failure.

The main questions it aims to answer is: Is video monitoring superior to monitoring via audio calls in patients with heart failure?

Researchers will compare monitoring by video to a monitoring by audio to see if drug videomonitoring works to improve selfcare in heart failure and other outocomes.

Participants will:

intervention group receive video calls guided by cardiologist nurses at 7, 30, 60, 180 and 365 days after hospital discharge.

the control group will receive audio calls for data collection, at the same time mentioned.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

  • Patients aged 18 years or older;
  • Admitted for decompensated HFrEF
  • Ejection fraction less than 40% confirmed by echocardiogram performed in the last 3 months
  • Who access to a mobile device with internet access

排除标准

  • heart transplant waiting list;
  • who had undergone coronary artery bypass in the last 3 months ;
  • who were in palliative care;
  • who had a life expectancy of less than 1 year

研究组 & 干预措施

Voice call group

No Intervention

Voice call by cardiovascular nurses

Videomonitoring Group

Experimental

Videomonitoring by cardiovascular nursing

干预措施: self-care (Behavioral)

结局指标

主要结局

Self-Care Behaviors Assessed by the European Self-Care Scale in Patients with Heart Failure

时间窗: 365 days after discharge

European Self-Care Scale The European self-care scale consists of 12 questions with a single domain related to self-care behavior. Responses to each item range from 1, "I completely agree", to 5, "I completely disagree", following a five-point Likert scale. The total score is obtained by summing all the responses, which can range from 12 to 60. Low values indicate better self-care. The items concern the various self-care behaviors of patients with heart failure, such as checking daily weight (item 1), rest (items 2 and 7), seeking help from the healthcare team (items 3, 4, 5 and 8), fluid restriction (item 6), diet (item 9), medication adherence (item 10), flu vaccination (item 11) and exercise (item 12)

次要结局

  • Rate of Cardiovascular Mortality within 365 Days Post-Discharge(365 days after discharge)
  • Frailty(365 days after discharge)
  • 7. Death Rates for Heart Failure within 365 Days Post-Discharge(365 days after discharge)
  • Cardiorespiratory Fitness Assessed by the Veterans Specific Activity Questionnaire (VSAQ)(365 days after discharge)
  • Quality of Life Assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)(365 days after discharge)
  • Adherence to Heart Failure Treatment Regimens asseded by "Adherence to HF treatment instrument"(365 days after discharge)
  • Heart Failure Knowledge Assessed by the HF Knowledge Questionnaire(365 days after discharge)
  • Hospitalization Rates for Heart Failure within 365 Days Post-Discharge(365 days after discharge)
  • Death Rates for Heart Failure within 365 Days Post-Discharge(365 days after discharge)

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

OMAR PEREIRA DE ALMEIDA NETO

Head

Federal University of Uberlandia

研究点 (1)

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