Knowledge of Living Will in Patients With Rheumatic Diseases

Knowledge of Living Will in Patients With Rheumatic Diseases. A Case-control Study

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Disorder
• Intervention / Treatment: 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

Detailed Description

A study will be carried out on patients with rheumatic diseases and healthy family controls. Patients will be selected from those attending the Department of Immunology and Rheumatology in Mexico City outpatient department, including consecutive cases.

The patients will be assessed for their quality of life and disability. Patients and controls will be evaluated on the knowledge of living will, their perceptions about specific health outcomes, sociodemographic characteristics, comorbidities, and psychiatric pathology.

• Study Type: Observational
• Enrollment (Estimated): 157

Contacts and Locations

• Study Contact: Name: Virginia Pascual-Ramos, Dr.; Phone Number: 4603 55 5487 0900; 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 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Cases

• Patients with severe diseases or in palliative care by a rheumatologist

Controls

- Withdrawal of the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients with rheumatic diseases from the outpatient clinic at a tertiary care level in Mexico City	Other: Health Assessment Questionnaire (HAQ); The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality; Other: Depression, Anxiety and Stress Scale (DASS-21); 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; Other: Brief Resilient Coping Scale; Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner; Other: WHOQOL-BREF; 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; Other: Routine assessment of patient index data 3 (RAPID-3); 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; Other: Rheumatic disease comorbidity index; 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; Other: Living will questionnaire; A questionnaire with 17 items about knowledge of the living will.; Other: Perceptions of Health Outcomes Questionnaire; 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.
Controls; Two patients´ relatives of the same sex, age ± five years and who are known to be healthy	Other: Health Assessment Questionnaire (HAQ); The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality; Other: Depression, Anxiety and Stress Scale (DASS-21); 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; Other: Brief Resilient Coping Scale; Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner; Other: WHOQOL-BREF; 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; Other: Rheumatic disease comorbidity index; 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; Other: Living will questionnaire; A questionnaire with 17 items about knowledge of the living will.; Other: Perceptions of Health Outcomes Questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Investigators: Principal Investigator: Virginia Pascual-Ramos, Dr., National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatic diseases; living will
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: IRE-4312

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