Rheumatic DisorderNCT05676359
Knowledge of Living Will in Patients With Rheumatic Diseases
An observational study of Rheumatic Disorder, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Disorder
- What is being tested?
- Health Assessment Questionnaire (HAQ), Depression, Anxiety and Stress Scale (DASS-21) and Brief Resilient Coping Scale
- How many people
- 157 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Cases
- Patients with severe diseases or in palliative care by a rheumatologist
- Controls
- Withdrawal of the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
Virginia Pascual-Ramos, MD, 00525555734111 ext. 533, virtichu@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Rheumatic Disorder
- Being tested
- Health Assessment Questionnaire (HAQ), Depression, Anxiety and Stress Scale (DASS-21), Brief Resilient Coping Scale, WHOQOL-BREF, Routine assessment of patient index data 3 (RAPID-3)
- Keywords
- Rheumatic diseases, living will
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Assessment Questionnaire (HAQ)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)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 ScaleOther
Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner
WHOQOL-BREFOther
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)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 indexOther
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 questionnaireOther
A questionnaire with 17 items about knowledge of the living will.
Perceptions of Health Outcomes QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with rheumatic diseases from the outpatient clinic at a tertiary care level in Mexico City Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 day At study inclusion (After their rheumatology consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Virginia Pascual-Ramos, Dr., Principal investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676359
- Sponsor's protocol ID
- IRE-4312
- Status last verified
- Sep 2023
- First submitted
- 15 Dec 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge of Living Will in Patients With Rheumatic Diseases. A Case-control Study
- ClinicalTrials.gov ID
- NCT05676359
- Acronym / sponsor ID
- IRE-4312
- Conditions
- Rheumatic Disorder
- Keywords
- Rheumatic diseases, living will
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | 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 QuestionnairePatients with rheumatic diseases from the outpatient clinic at a tertiary care level in Mexico City |
| Controls | – | 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 QuestionnaireTwo patients´ relatives of the same sex, age ± five years and who are known to be healthy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Cases
- Patients with severe diseases or in palliative care by a rheumatologist
- Controls
- Withdrawal of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Assessment Questionnaire (HAQ)The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality | Other | Cases, Controls |
| 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 | Cases, Controls |
| Brief Resilient Coping ScaleBrief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner | Other | Cases, Controls |
| WHOQOL-BREFWHOQOL-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 | Cases, Controls |
| 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 | Cases |
| Rheumatic disease comorbidity indexIt 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 | Cases, Controls |
| Living will questionnaireA questionnaire with 17 items about knowledge of the living will. | Other | Cases, Controls |
| Perceptions of Health Outcomes QuestionnaireA 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. | Other | Cases, Controls |
Primary outcome
Knowledge of the living will with the living will questionnaire (locally development)
Time frame: 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.
Perceptions of Health Outcomes with the perceptions of health outcomes questionnaire (locally development)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Pascual-Ramos, Dr. principal investigator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Disorder, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia Pascual-Ramos, Dr. (55 5487 0900 ext. 4603, virtichu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of the living will with the living will questionnaire (locally development) (time frame: 1 day At study inclusion (After their rheumatology consultation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.