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临床试验/NCT04648098
NCT04648098已完成不适用

The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial

Kırklareli University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Caregiver Burden Scale

研究概览

简要总结

The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.

详细描述

This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.

In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.

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
Double (Investigator, 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
否

入选标准

  • •the age of 18 and over (for patients and caregivers)
  • •having undergone a hemorrhagic or ischemic stroke (for patients)
  • •being literate (for caregivers)
  • •being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
  • •using a mobile or home phone (for caregivers)
  • •being open to communication and collaboration (for caregivers)

排除标准

  • •Rankin Scale score of 4 above (for patients)
  • •Having problem in terms of hearing and understanding (for caregivers)

研究组 & 干预措施

Experimental: Intervention group

Experimental

Discharge training and telephone counseling

干预措施: Discharge training and telephone counseling (Other)

No Intervention: Control Group

No Intervention

Routine care

结局指标

主要结局

Caregiver Burden Scale

时间窗: Change from baseline score at the end of the third month

Caregiver Burden Scale, developed by Zarit et al. (1980), was used to evaluate the care burden of patient relatives. There are 22 expressions in the scale that determine the effect of caregiving on the individual's life. The score obtained from the five-point Likert scale is minimum 0 and maximum 88.A high score on the scale indicates that the problem experienced by the caregiver is high.

The Barthel Index

时间窗: Change from baseline score at the end of the third month

The Barthel Index to developed by Mahoney and Barthel in 1965 to evaluate physical independence in daily life activities. Index consists of 10 items that include daily life activities and is used to evaluate the level of functional independence. Items in the scale are graded between 0 and 15 points in 5 increments according to the question. The score ranges from 0 to 100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points slightly dependent, 100 points fully independent).

Modified Rankin Scale

时间窗: Change from baseline score at the end of the third month

Modified Rankin Scale evaluating the functional limitation and degree of addiction occurring in the patient after stroke was evaluated in seven categories (0: No symptoms, 1: No obvious deficits, 2: Mild deficits, 3: Moderate deficits, 4: Severe deficits, 5: Very severe deficit and 6: Death).

次要结局

未报告次要终点

研究者

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

Deniz Ezgi Bitek

Principal Investigator

Kırklareli University

研究点 (1)

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