跳至主要内容
临床试验/NCT06742827
NCT06742827进行中(未招募)不适用

Effectiveness of an Educational Intervention by Nurses Supported by ICTs to Improve Therapeutic Adherence in People Undergoing Hemodialysis Treatment

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Score of ESRD-AQ

研究概览

简要总结

quasi-experimental, parallel study, with the objective of evaluating the effectiveness of an educational nursing intervention supported by ICTs, for the improvement of therapeutic adherence in people undergoing hemodialysis treatment in a renal unit in Barranquilla (Colombia)

详细描述

This study is quantitative in approach and will be conducted in three phases: Phase I: development of the intervention, Phase II: validation by expert consensus for the content of the nursing intervention. Phase III a randomized clinical trial.

I. Development of the intervention During this phase knowledge gained from theoretical and empirical approaches will play a key role in creating an effective intervention aimed at improving treatment adherence in hemodialysis patients. An intervention guided by salutogenic theory and mediated by ICTs will be used. Each of these approaches provides a unique and valuable perspective that enriches our understanding of the problem, thus facilitating informed decision making during the planning and implementation phase of interventions.

As for the theoretical-empirical understanding of the problem, which will perform the combination of theoretical and empirical approach in order to make the clear identification of the problem, requiring resolution of its determinants, severity, consequences, as well as, evidencing the support of the intervention through the incorporation of theories that guide the development of the intervention while seeking to establish the relationship between the characteristics of the problem and empirical components.

Description of the Nursing Educational Intervention:

Regarding the theoretical approach, Antonovsky's salutogenic theory is incorporated, which makes it possible to understand the problem. This theory, which is broad and comprehensive, adopts a salutogenic perspective by viewing people as biopsychosocial beings who make choices in their lives. It allows individuals to identify the psychosocial resources that contribute to maintaining their health and well-being. In this sense, Antonovsky introduces the concept of "sense of coherence", which comprises the elements of comprehensibility (knowledge), manageability (behavior) and meaningfulness (motivation).

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 18 and 60 years old
  • •In hemodialysis treatment for at least 3 months for three or four hours, with a frequency of three times a week in a renal
  • •Must live in Barranquilla
  • •Must be independent in self-care activities such as being able to walk and eat without assistance
  • •Must have access to an Android or Apple cell phone which is in daily use.

排除标准

  • •Signs or symptoms as a result of target organ damage
  • •Cognitive, hearing or visual impairments that prevent them from adequately receiving the educational intervention.

研究组 & 干预措施

Intervention

Experimental

Intervention group: participants will receive an educational intervention on hemodialysis adherence)

干预措施: educational intervention based on information and communication technologies. (Other)

Control

No Intervention

Control group:participants will receive conventional care provided by health professionals

结局指标

主要结局

Score of ESRD-AQ

时间窗: PRE (baseline, pre-intervention) and POST (immediately after the intervention)

Score of the End-Stage Renal Disease-Adherence Questionnaire (ESRD-AQ)

Score of SOC

时间窗: PRE (baseline, pre-intervention) and POST (immediately after the intervention)

Score of the scale Sense of Coherence (SOC)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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