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

NCT ID: NCT05248464

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 309 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-01

Brief 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.

Detailed 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

Conditions

Rheumatic Diseases; Dignity; Quality of Life; Distress, Emotional

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Rheumatic diseases patients

All the rheumatic diseases outpatients from the National Institute of Medical Sciences

The Patient Dignity Inventory instrument (PDI)

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Virginia Pascual Ramos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Virgina MD Pascual-Ramos

Role: CONTACT

virtichu@gmail.com

525555734111 ext. 533

Facility Contacts

Virginia Pascual-Ramos, MD

Role: primary

virtichu@gmail.com

00525555734111 ext. 533

References

Pascual-Ramos V, Contreras-Yanez I, Cuevas-Montoya M, Guaracha-Basanez G, Garcia-Alanis M, Rodriguez-Mayoral O, Chochinov HM. The impact of underlying RMD diagnosis on dignity landscape in patients with systemic lupus erythematosus, rheumatoid arthritis, and systemic sclerosis. Medicine (Baltimore). 2025 Jul 18;104(29):e43303. doi: 10.1097/MD.0000000000043303.

Reference Type: DERIVED

PMID: 40696675 (View on PubMed)

Other Identifiers

IRE-4031-22/23-1

Identifier Type: -

Identifier Source: org_study_id