Knowledge of Living Will in Patients With Rheumatic Diseases

NCT05676359 | Unknown

• 1 other identifier: IRE-4312
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

The living will is a legal document derived from a communication and deliberation process, medical ethical aspect, currently regulated in Mexico by the General Health Law and the Health Law of Mexico City. Knowledge of living will in the population with chronic diseases, including rheumatic diseases, has been little addressed. Most patients do not know what the living will document is, so they do not carry it out and others, despite knowing it, have a passive attitude toward doing it.

Conditions

Rheumatic Disorder

Keywords

Rheumatic diseases; living will

Outcome Measures

Primary Outcomes (2)

• Knowledge of the living will with the living will questionnaire (locally development)

  To evaluate the knowledge of the living will, using the living will questionnaire (locally development), among the patients with rheumatic diseases and healthy controls.

  1 day At study inclusion (After their rheumatology consultation)

• Perceptions of Health Outcomes with the perceptions of health outcomes questionnaire (locally development)

  To evaluate the perceptions of the of health outcomes using the perceptions of health outcomes questionnaire (locally development), among the patients with rheumatic diseases and healthy controls

  1 day At study inclusion (After their rheumatology consultation)

Study Arms (2)

Cases

Patients with rheumatic diseases from the outpatient clinic at a tertiary care level in Mexico City

Other: Health Assessment Questionnaire (HAQ); Other: Depression, Anxiety and Stress Scale (DASS-21); Other: Brief Resilient Coping Scale; Other: WHOQOL-BREF; Other: Routine assessment of patient index data 3 (RAPID-3); Other: Rheumatic disease comorbidity index; Other: Living will questionnaire; Other: Perceptions of Health Outcomes Questionnaire

Controls

Two patients´ relatives of the same sex, age ± five years and who are known to be healthy

Other: Health Assessment Questionnaire (HAQ); Other: Depression, Anxiety and Stress Scale (DASS-21); Other: Brief Resilient Coping Scale; Other: WHOQOL-BREF; Other: Rheumatic disease comorbidity index; Other: Living will questionnaire; Other: Perceptions of Health Outcomes Questionnaire

Interventions

Health Assessment Questionnaire (HAQ) OTHER

The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality

Cases; Controls

Depression, Anxiety and Stress Scale (DASS-21) OTHER

DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content

Cases; Controls

Brief Resilient Coping Scale OTHER

Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner

Cases; Controls

WHOQOL-BREF OTHER

WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items

Cases; Controls

Routine assessment of patient index data 3 (RAPID-3) OTHER

RAPID- 3 measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30

Cases

Rheumatic disease comorbidity index OTHER

It is rated from 0 to 9 and comprises 11 comorbid conditions including lung disease, cardio-vascular disease, hypertension, diabetes, fracture, depression, cancer, and gastrointestinal ulcer

Cases; Controls

Living will questionnaire OTHER

A questionnaire with 17 items about knowledge of the living will.

Cases; Controls

Perceptions of Health Outcomes Questionnaire OTHER

A questionnaire with 7 items about the probability of quitting the job, getting an infectious disease, requiring emergency medical attention, hospitalization or intensive care, dependence and death.

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from those attending the Department of Immunology and Rheumatology in Mexico City outpatient department, and the controls will be patients´ relatives of the same sex, age ± five years and who are known to be healthy

You may qualify if:

• Cases
• Patients with a rheumatic disease diagnostic by a rheumatologist
• Patients with rheumatic diseases attending the Department of Immunology and Rheumatology in Mexico City outpatient department
• Patients who agree to participate in the study, who complete and sign the informed consent Controls
• Relative of a patient with rheumatic diseases of the same sex and age ± 5 years, without known rheumatic and/or chronic disease and without the use of pharmacological treatment for more than 7 days during the month before study entry.

You may not qualify if:

• Cases
• Patients with severe diseases or in palliative care by a rheumatologist
• Controls
• \- Withdrawal of the study

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

ametantrone

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Virginia Pascual-Ramos, Dr.

  National Institute of Medical Sciences and Nutrition, Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Pascual-Ramos, Dr.

CONTACT

55 5487 0900; virtichu@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 9, 2023
• Study Start: February 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)