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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05248464
Other study ID # IRE-4031-22/23-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2023

Study information

Verified date February 2022
Source National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Contact Virgina MD Pascual-Ramos
Phone 525555734111
Email virtichu@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 309
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate Exclusion Criteria: - Patients with a not confirmed rheumatic disease

Study Design


Intervention

Other:
The Patient Dignity Inventory instrument (PDI)
The PDI is an instrument made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind, and social support, prior to its application, adaptation, and validation will performer
WHOQOL-BREF (quality of life) instrument
The WHOQOL-BREF is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment, it consists of 24 items.

Locations

Country Name City State
Mexico Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD 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 Baseline (At study inclusion)
Secondary Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument Baseline (At study inclusion)
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