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临床试验/NCT05285163
NCT05285163已完成不适用

The Effect of Palliative Care Training on Symptom Management, Rehospitalization and Quality of Life in Chronic Heart Failure: : A Randomized Controlled Trial

Marmara University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Edmonton symptom assessment scale

研究概览

简要总结

Palliative care is of great importance because of poor quality of life and high mortality risk in advanced heart failure. This study was planned as a randomized controlled trial to determine the effect of palliative care training on symptom management, rehospitalization, and quality of life among patients with heart failure.

详细描述

Patients were informed about the research and written informed consent was obtained. Data were collected by face-to-face interviews within two days before discharge. Patient information form and scales were applied to Patients in the intervention and control groups. Patients in the intervention group were received education after filling the forms. The training was given one by one at the hospital. One or two relatives of patients were included in the training. The patient was comfortably seated, and the room door was closed, face to face interaction was conducted. The patient and his/her relatives were allowed to ask questions during the training. The patient in the intervention group received at least 45 minutes of data collection from a case because of detailed training. It took about 15 minutes to collect data from a patient in the control group. In some patients, the training program was divided to be clearer. The patients were traced by telephone at the first, third, and sixth months after discharge. The investigator's phone number was presented to the patients and they were told that they could call at any time. Continuous communication was ensured by giving the educator's phone number to the patients. The training was repeated by contacting the phone. The intervention group was retrained about symptoms they experienced during their telephone interview. The training was given to the experimental group as planned. No modifications/changes were made to the intervention during the study. Special notes were taken for each patient. The effect of the education given on the quality of life and symptom management was evaluated with questionnaires. The intervention was adhered to as planned.

研究设计

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

盲法说明

The patients were distributed with the minimization method of covariate-oriented randomization. According to NYHA (class III, IV), sex (male and female), and the number of hospitalizations (≤3 and ≥4) within one year, the patients were randomly appointed to the control and intervention groups. Thus, the patients in the intervention and control groups were distributed as homogeneous.

入排标准

年龄范围
18 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-year-old or over,
  • Class III and IV heart failure patients according to New York Heart Association (NYHA) classification,
  • Patients without any communication problem to prevent participation in the research [loss of hearing, visual impairment, lack of understanding/speaking in Turkish], can be contacted by telephone, are literate.
  • The patients who were diagnosed with heart failure at least six months ago accepted to participate voluntarily were also included in the study.

排除标准

  • Patients who wish to quit their study voluntarily during the study period and patients who died or worsened during the study period.

结局指标

主要结局

Edmonton symptom assessment scale

时间窗: six months

ESAS consists of 10 symptoms as tiredness, pain, feeling of well-being, nausea, depression, anxiety, lack of appetite, drowsiness, shortness of breath, and others. Each symptom is scored between 0 and 10. While Zero points indicate no symptoms, 10 points are severe of symptoms.

次要结局

  • LVD-36-left ventricular dysfunction questionnaire(six months)

研究者

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

Gülşah Çamcı

Assistant Prof

Marmara University

研究点 (2)

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