Knowledge of Living Will in Patients With Rheumatic Diseases

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676359
Collaborator
(none)
157
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
157 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Knowledge of Living Will in Patients With Rheumatic Diseases. A Case-control Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge of the living will with the living will questionnaire (locally development) [1 day At study inclusion (After their rheumatology consultation)]

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

  2. Perceptions of Health Outcomes with the perceptions of health outcomes questionnaire (locally development) [1 day At study inclusion (After their rheumatology consultation)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 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:
NCT05676359
Other Study ID Numbers:
  • IRE-4312
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 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
Keywords provided by Virginia Pascual Ramos, Principal Investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023