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RecruitingNCT05676359Updated Sep 26, 2023

Knowledge of Living Will in Patients With Rheumatic Diseases

An observational study in Rheumatic Disorder, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Observational

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
157
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatic Disorder

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Keywords

  • Rheumatic diseases
  • living will
03

In context

Rheumatic Diseases

264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.

This study's planned enrollment of 157 is below the median of 225 across 90 observational studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

Cases

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

Controls

  • Withdrawal of the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
157 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherHealth Assessment Questionnaire (HAQ)

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

  • OtherDepression, 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

  • OtherBrief 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

  • OtherWHOQOL-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

  • OtherRoutine 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

  • OtherRheumatic 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

  • OtherLiving will questionnaire

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

  • OtherPerceptions 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day At study inclusion (After their rheumatology consultation)

  2. 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

    Time frame: 1 day At study inclusion (After their rheumatology consultation)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05676359
Lead sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Responsible party
Virginia Pascual Ramos (Principal Investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran) — Principal investigator
First posted
Jan 9, 2023
Start date
Feb 1, 2023
Primary completion
Jul 31, 2023
Completion
Jul 31, 2024 (estimated)
Last update
Sep 26, 2023

Study contacts

Virginia Pascual-Ramos, Dr.
Contact
virtichu@gmail.com
55 5487 0900 ext. 4603
Virginia Pascual-Ramos, Dr.
principal investigator · National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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