NCT05248464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

January 30, 2022

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Baseline (At study inclusion)

Study Arms (1)

Rheumatic diseases patients

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

Other: The Patient Dignity Inventory instrument (PDI)Other: WHOQOL-BREF (quality of life) instrument

Interventions

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

Rheumatic diseases patients

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.

Rheumatic diseases patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

You may not qualify if:

  • Patients with a not confirmed rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Virgina MD Pascual-Ramos

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2022

First Posted

February 21, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations