Rheumatic DiseasesNCT05248464
Distress Related to the Feeling of Loss of Dignity in Patients With Rheumatic Diseases
An observational study of Rheumatic Diseases and Dignity, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
Rheumatic diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatic Diseases, Dignity, Quality of Life
- What is being tested?
- The Patient Dignity Inventory instrument (PDI) and WHOQOL-BREF (quality of life) instrument
- How many people
- 309 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2022to 1 Mar 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the rheumatic diseases from the National Institute of Medical Sciences and Nutrition
Who may be able to join
- Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate
Who cannot join
- Patients with a not confirmed rheumatic disease
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: Association Between the Presence of Distress Related to the Feeling of Loss of Dignity and Quality of Life in Patients With Rheumatic Diseases
Rheumatic diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population.
Dignity is a construct characterized by the representation of the self, of the self from others' point of view, and of the interaction of the individual with the environment and social context.
Read more
Living with a chronic illness can threaten experiences of dignity for the sick person and their families. Various studies have demonstrated the direct impact of the disease on dignity in terms of physical and psychological symptoms and loss of function. Some efforts have been made to operationalize the concept of perceived dignity in the context of chronic diseases
The perceived dignity of patients and the distress related to the feeling of loss of dignity (DRFLD) are outcomes that the patient can report and that the doctors can evaluate to be incorporated into the considerations of comprehensive care. Both outcomes are closely related, perceived dignity refers to a complex phenomenon, while distress related to the feeling of loss of dignity identifies those patients with a perceived dignity compromise of such magnitude that it generates anguish.
Read the detailed description
The Patient Dignity Inventory (PDI) is an instrument originally written in English made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind and social support. Has a Likert-type response system with a 5-point scale, ranging from 1 ''not a problem'' to 5 ''very serious problem"; higher scores indicate greater dignity-related distress.
The PDI has been translated and validated into different languages, including validation in Spanish. The PDI instrument was validated in Mexico by Rodríguez-Mayoral et al., in 290 cancer patients. It had very good reliability with an alpha of 0.95 and a 4-factor structure that explained 64% of the variance (loss of meaning in life, loss of autonomy, dependency, and social support).
The primary objective of the study is the association between the presence of distress related to the feeling of loss of dignity and quality of life in patients with RD
- Conditions
- Rheumatic Diseases, Dignity, Quality of Life, Distress, Emotional
- Being tested
- The Patient Dignity Inventory instrument (PDI), WHOQOL-BREF (quality of life) instrument
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Patient Dignity Inventory instrument (PDI)Other
The PDI is an instrument made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind, and social support, prior to its application, adaptation, and validation will performer
WHOQOL-BREF (quality of life) instrumentOther
The WHOQOL-BREF is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment, it consists of 24 items.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatic diseases patients | All the rheumatic diseases outpatients from the National Institute of Medical Sciences Receives: Other: The Patient Dignity Inventory instrument (PDI); Other: WHOQOL-BREF (quality of life) instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD, using PDI (distress related to the feeling of loss of dignity) instrument
Measured: Baseline (At study inclusion)
Secondary outcomes (1)
Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument
Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument
Measured: Baseline (At study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 309 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248464
- Sponsor's protocol ID
- IRE-4031-22/23-1
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pascual-Ramos V, Contreras-Yanez I, Cuevas-Montoya M, Guaracha-Basanez G, Garcia-Alanis M, Rodriguez-Mayoral O, Chochinov HM. The impact of underlying RMD diagnosis on dignity landscape in patients with systemic lupus erythematosus, rheumatoid arthritis, and systemic sclerosis. Medicine (Baltimore). 2025 Jul 18;104(29):e43303. doi: 10.1097/MD.0000000000043303.
PubMed 40696675
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Presence of Distress Related to the Feeling of Loss of Dignity and Quality of Life in Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT05248464
- Acronym / sponsor ID
- IRE-4031-22/23-1
- Conditions
- Rheumatic Diseases, Dignity, Quality of Life, Distress, Emotional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 Feb 2022 (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.
Rheumatic diseases (RD) are an important group of different clinical entities and specific diseases that affect a significant proportion of the world population. In Mexico, the RD have a relevant representation in the adult population.
Dignity is a construct characterized by the representation of the self, of the self from others' point of view, and of the interaction of the individual with the environment and social context.
Living with a chronic illness can threaten experiences of dignity for the sick person and their families. Various studies have demonstrated the direct impact of the disease on dignity in terms of physical and psychological symptoms and loss of function. Some efforts have been made to operationalize the concept of perceived dignity in the context of chronic diseases
The perceived dignity of patients and the distress related to the feeling of loss of dignity (DRFLD) are outcomes that the patient can report and that the doctors can evaluate to be incorporated into the considerations of comprehensive care. Both outcomes are closely related, perceived dignity refers to a complex phenomenon, while distress related to the feeling of loss of dignity identifies those patients with a perceived dignity compromise of such magnitude that it generates anguish.
Detailed description
The Patient Dignity Inventory (PDI) is an instrument originally written in English made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind and social support. Has a Likert-type response system with a 5-point scale, ranging from 1 ''not a problem'' to 5 ''very serious problem"; higher scores indicate greater dignity-related distress.
The PDI has been translated and validated into different languages, including validation in Spanish. The PDI instrument was validated in Mexico by Rodríguez-Mayoral et al., in 290 cancer patients. It had very good reliability with an alpha of 0.95 and a 4-factor structure that explained 64% of the variance (loss of meaning in life, loss of autonomy, dependency, and social support).
The primary objective of the study is the association between the presence of distress related to the feeling of loss of dignity and quality of life in patients with RD
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatic diseases patients | – | Other: The Patient Dignity Inventory instrument (PDI), Other: WHOQOL-BREF (quality of life) instrumentAll the rheumatic diseases outpatients from the National Institute of Medical Sciences |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the rheumatic diseases from the National Institute of Medical Sciences and Nutrition
Key inclusion criteria (1 listed)
- Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate
Key exclusion criteria (1 listed)
- Patients with a not confirmed rheumatic disease
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 |
|---|---|---|
| The Patient Dignity Inventory instrument (PDI)The PDI is an instrument made up of 25 items integrated into 5 factors that include: symptoms, existential anguish, dependency, peace of mind, and social support, prior to its application, adaptation, and validation will performer | Other | Rheumatic diseases patients |
| WHOQOL-BREF (quality of life) instrumentThe WHOQOL-BREF is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment, it consists of 24 items. | Other | Rheumatic diseases patients |
Primary outcome
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD
Time frame: Baseline (At study inclusion)
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD, using PDI (distress related to the feeling of loss of dignity) instrument
1 secondary outcome
Determine the quality of life in patients with RD, using WHOQOL-BREF (quality of life) instrument
Time frame: Baseline (At study inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 40696675Pascual-Ramos V, Contreras-Yanez I, Cuevas-Montoya M, Guaracha-Basanez G, Garcia-Alanis M, Rodriguez-Mayoral O, Chochinov HM. The impact of underlying RMD diagnosis on dignity landscape in patients with systemic lupus erythematosus, rheumatoid arthritis, and systemic sclerosis. Medicine (Baltimore). 2025 Jul 18;104(29):e43303. doi: 10.1097/MD.0000000000043303.
- 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.
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 Diseases and Dignity, 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 1 inclusion and 1 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 6 Apr 2022. 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 Virgina MD Pascual-Ramos (525555734111 ext. 533, virtichu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence (percentage) of the presence of distress related to the feeling of loss of dignity in patients with RD (time frame: Baseline (At study inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248464, which also lists 1 linked publication.
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 6 Apr 2022.