Distress Related to the Feeling of Loss of Dignity in Patients With Rheumatic Diseases

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248464
• Other study ID #: IRE-4031-22/23-1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Collagen Diseases
• Dignity
• Distress, Emotional
• Quality of Life
• Rheumatic Diseases

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)