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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Rheumatic Diseases; Dignity; Distress, Emotional
• Intervention / Treatment: Other: The Patient Dignity Inventory instrument (PDI); Other: WHOQOL-BREF (quality of life) instrument

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

• Study Type: Observational
• Enrollment (Anticipated): 309

Contacts and Locations

• Study Contact: Name: Virgina MD Pascual-Ramos; Phone Number: 533 525555734111; Email: virtichu@gmail.com

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Contact: Virginia Pascual-Ramos, MD; Phone Number: 533 00525555734111; Email: virtichu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the rheumatic diseases from the National Institute of Medical Sciences and Nutrition

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Rheumatic diseases patients; All the rheumatic diseases outpatients from the National Institute of Medical Sciences

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: IRE-4031-22/23-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No