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临床试验/NCT03830658
NCT03830658已完成不适用

Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients: a Quasi-experimental Study

Instituto Portugues de Oncologia, Francisco Gentil, Porto2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2018年1月2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
发起方
入组人数
89
试验地点
2
主要终点
scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)

研究概览

简要总结

End stage renal disease patients (ESRD) should be educated to take care of their arteriovenous fistula (AVF). Educational programs should have clear objectives and the interventions should be well defined. Therefore, assessing the interventions that can have the strongest impact on the patient's acquisition of self-care behaviors with AVF is extremely important. The aim is to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with AVF by patients with ESRD on hemodialysis (HD).

详细描述

This was a quasi-experimental study in dialysis units, involving patients using AVF for HD. The dialysis units are located in the north of Portugal (two units) and in the Autonomous Region of the Azores (one unit). The study started after approval by the institution ethics committee.

Study Setting and Population The study was carried out in dialysis units the north of Portugal, identified as Control Group (CG), and on an island in the Autonomous Region of the Azores, identified as Intervention Group (IG).

Data Collection and Instrument All data were collected from January to June 2018. Information concerning the sample demographic characteristics (age, gender, education, employment, marital status) and clinical characteristics (ESRD etiology, dialysis vintage, previous AVFs, AVF duration, information on care with the AVF) was collected with a questionnaire designed by the authors.

Information concerning self-care behaviors with the AVF was collected from the Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF) (8). This scale has 16 items in two subscales: subscale 1 - Management of Signs and Symptoms (6 items) and subscale 2 - Prevention of Complications (10 items). Responses to each item are based on a 5-point Likert-type scale. Higher scores show patients' higher frequency of self-care with the AVF. The ASBHD-AVF scale has been applied to Portuguese patients with Cronbach's alpha of 0.797, 0.797 and 0.722 for the global scale and sub-scales 1 and 2, respectively.

Memory problems were assessed by the Six-Item Cognitive Impairment Test (6CIT), Portuguese version (9).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • participants should be 18 years or older;
  • have an AVF duration on HD greater than 6 months
  • have no memory problems
  • be medically stable.

排除标准

  • patients with double vascular access (central venous catheter and AVF) or grafts as vascular access
  • hospitalized patients at the time of data collection

研究组 & 干预措施

Structured Intervention on Self-care with AVF

Experimental

The structured intervention designed for this study was a multimethod approach with the purpose of capturing the learning styles of most patients through the use of written, listening and visual learning (10). Structured Intervention on Self-care with AVF (SISC-AVF) has been designed taking into account the structure of care to the person with AVF developed by Sousa (11). The SISC-AVF had the purpose of identifying the signs/symptoms or situations jeopardizing AVF working and includes both a theoretical and a practical part.

干预措施: Structured Intervention on Self-care with AVF (SISC-AVF) (Behavioral)

Usual-Care Control

Active Comparator

Educational training was given during HD sessions. The dialysis nurse provided information about arteriovenous fistula care and trained the patient when he/she felt it was required. The dialysis units had no documentation concerning the educational training given to patients and the moment to provide such information was not defined, either.

干预措施: Structured Intervention on Self-care with AVF (SISC-AVF) (Behavioral)

结局指标

主要结局

scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)

时间窗: Change from baseline self-care behaviors at 12 months

self-care behaviors with arteriovenous

次要结局

  • scale of assessment of self-care behaviors with arteriovenous fistula in hemodialysis (ASBHD-AVF)(Change from baseline self-care behaviors at 12 months)

研究者

发起方
Instituto Portugues de Oncologia, Francisco Gentil, Porto
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clemente Neves Sousa

Clinical Professor

Instituto Portugues de Oncologia, Francisco Gentil, Porto

研究点 (2)

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