Knowledge of Living Will in Patients With Rheumatic Diseases

NCT ID: NCT05676359

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatic Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

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

Health Assessment Questionnaire (HAQ)

Intervention Type OTHER

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

Depression, Anxiety and Stress Scale (DASS-21)

Intervention Type 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

Brief Resilient Coping Scale

Intervention Type OTHER

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

WHOQOL-BREF

Intervention Type 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

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

Intervention Type 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

Rheumatic disease comorbidity index

Intervention Type 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

Living will questionnaire

Intervention Type OTHER

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

Perceptions of Health Outcomes Questionnaire

Intervention Type 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.

Controls

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

Health Assessment Questionnaire (HAQ)

Intervention Type OTHER

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

Depression, Anxiety and Stress Scale (DASS-21)

Intervention Type 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

Brief Resilient Coping Scale

Intervention Type OTHER

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

WHOQOL-BREF

Intervention Type 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

Rheumatic disease comorbidity index

Intervention Type 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

Living will questionnaire

Intervention Type OTHER

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

Perceptions of Health Outcomes Questionnaire

Intervention Type 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.

Interventions

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Health Assessment Questionnaire (HAQ)

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Living will questionnaire

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Virginia Pascual Ramos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginia Pascual-Ramos, Dr.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Virginia Pascual-Ramos, Dr.

Role: CONTACT

55 5487 0900 ext. 4603

Facility Contacts

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Virginia Pascual-Ramos, MD

Role: primary

00525555734111 ext. 533

Other Identifiers

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IRE-4312

Identifier Type: -

Identifier Source: org_study_id

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