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临床试验/NCT05248464
NCT05248464Unknown不适用

Association Between the Presence of Distress Related to the Feeling of Loss of Dignity and Quality of Life in Patients With Rheumatic Diseases

National Institute of Medical Sciences and Nutrition, Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
309
试验地点
1
主要终点
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD

研究概览

简要总结

Rheumatic diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population.

Dignity is a construct characterized by the representation of the self, of the self from others' point of view, and of the interaction of the individual with the environment and social context.

Living with a chronic illness can threaten experiences of dignity for the sick person and their families. Various studies have demonstrated the direct impact of the disease on dignity in terms of physical and psychological symptoms and loss of function. Some efforts have been made to operationalize the concept of perceived dignity in the context of chronic diseases

The perceived dignity of patients and the distress related to the feeling of loss of dignity (DRFLD) are outcomes that the patient can report and that the doctors can evaluate to be incorporated into the considerations of comprehensive care. Both outcomes are closely related, perceived dignity refers to a complex phenomenon, while distress related to the feeling of loss of dignity identifies those patients with a perceived dignity compromise of such magnitude that it generates anguish.

详细描述

The Patient Dignity Inventory (PDI) is an instrument originally written in English made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind and social support. Has a Likert-type response system with a 5-point scale, ranging from 1 ''not a problem'' to 5 ''very serious problem"; higher scores indicate greater dignity-related distress.

The PDI has been translated and validated into different languages, including validation in Spanish. The PDI instrument was validated in Mexico by Rodríguez-Mayoral et al., in 290 cancer patients. It had very good reliability with an alpha of 0.95 and a 4-factor structure that explained 64% of the variance (loss of meaning in life, loss of autonomy, dependency, and social support).

The primary objective of the study is the association between the presence of distress related to the feeling of loss of dignity and quality of life in patients with RD

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

排除标准

  • Patients with a not confirmed rheumatic disease

结局指标

主要结局

Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD

时间窗: Baseline (At study inclusion)

Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD, using PDI (distress related to the feeling of loss of dignity) instrument

次要结局

  • Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument(Baseline (At study inclusion))

研究者

发起方
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Virginia Pascual Ramos

Principal Investigator

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

研究点 (1)

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