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

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran (Other)
Overall Status
Recruiting
CT.gov ID
NCT05248464
Collaborator
(none)
309
Enrollment
1
Location
12
Anticipated Duration (Months)
25.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
309 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

    Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránMexico CityMexico14080

Sponsors and Collaborators

  • National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Pascual Ramos, Principal Investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT05248464
Other Study ID Numbers:
  • IRE-4031-22/23-1
First Posted:
Feb 21, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022