Rheumatic DiseasesNCT06233760
Prevalence of Abuse Among Patients With Rheumatic Diseases
An observational study of Rheumatic Diseases and Abuse Neglect, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatic Diseases, Abuse Neglect, Abuse
- What is being tested?
- Rheumatic diseases Mistreatment Scale (RDMS), Health Assessment Questionnaire (HAQ) and Depression, Anxiety and Stress Scale (DASS-21)
- How many people
- 244 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2023to 2 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All the rheumatic diseases outpatients from the National Institute of Medical Sciences
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
Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.
Regarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.
The study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored.
Read the detailed description
Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.
In 1970, the phenomenon of abuse in geriatric patients was described for the first time as a phenomenon identified as a public health problem and an issue of human rights violation.
In 2012 Giraldo-Rodríguez developed and validated the Geriatric Abuse Scale (GAS), an instrument that, with adequate psychometric properties, reported a prevalence of abuse of 10.28% in Mexico.
Regarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.
The study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored.
- Conditions
- Rheumatic Diseases, Abuse Neglect, Abuse
- Being tested
- Rheumatic diseases Mistreatment Scale (RDMS), Health Assessment Questionnaire (HAQ), Depression, Anxiety and Stress Scale (DASS-21), Brief Resilient Coping Scale, WHOQOL-BREF
- Keywords
- rheumatic diseases, Abuse
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheumatic diseases Mistreatment Scale (RDMS)Other
Also called RD-MS
In 2012 Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS), prior to its application, translation, cultural adaptation, and validation were performed.
Health Assessment Questionnaire (HAQ)Other
Also called HAQ
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
Also called 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
Brief Resilient Coping ScaleOther
Also called BRCS
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
Also called 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
Big Five InventoryOther
Also called BFI-10
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
Family APGAR QuestionnaireOther
Also called APGAR
Family APGAR questionnaire is used to evaluate family function, in the context of family medical care
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatic diseases | All the rheumatic diseases outpatients from the National Institute of Medical Sciences Receives: Other: Rheumatic diseases Mistreatment Scale (RDMS); 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: Big Five Inventory; Other: Family APGAR Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Mexican patients with RD who will present the phenomenon of mistreatment
Identify the percentage of patients with rheumatic diseases that present mistreatment using the instrument developed by Giraldo-Rodríguez et al (translation, cultural adaptation, and validation performed)
Measured: At inclusion (baseline moment) (cross-sectional study)
Secondary outcomes (1)
Identify factors associated with mistreatment among patients with rheumatic diseases
Identify factors associated with mistreatment among patients with rheumatic diseases using an instrument locally development
Measured: At inclusion (baseline moment) (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Apr 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 244 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 Dr Pascual-Ramos, Principal investigator, INNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233760
- Sponsor's protocol ID
- IRE3234
- Status last verified
- Mar 2024
- First submitted
- 14 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giraldo-Rodriguez L, Rosas-Carrasco O. Development and psychometric properties of the Geriatric Mistreatment Scale. Geriatr Gerontol Int. 2013 Apr;13(2):466-74. doi: 10.1111/j.1447-0594.2012.00894.x. Epub 2012 Jun 14.
PubMed 22694594Castro I, Barrantes F, Tuna M, Cabrera G, Garcia C, Recinos M, Espinoza LR, Garcia-Kutzbach A. Prevalence of abuse in fibromyalgia and other rheumatic disorders at a specialized clinic in rheumatic diseases in Guatemala City. J Clin Rheumatol. 2005 Jun;11(3):140-5. doi: 10.1097/01.rhu.0000164823.78761.a2.
PubMed 16357732Contreras-Yanez I, Ledon-LLanes L, Guaracha-Basanez GA, Sanchez-Hernandez A, Ortiz-Haro AB, Pascual-Ramos V. Perceived mistreatment in patients with rheumatic diseases: The impact of the underlying diagnosis. PLoS One. 2024 Dec 30;19(12):e0316312. doi: 10.1371/journal.pone.0316312. eCollection 2024.
PubMed 39775374
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Abuse Among Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT06233760
- Acronym / sponsor ID
- IRE3234
- Conditions
- Rheumatic Diseases, Abuse Neglect, Abuse
- Keywords
- rheumatic diseases, Abuse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 31 Jan 2024 (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.
Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.
Regarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.
The study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored.
Detailed description
Patients with rheumatic diseases (RD) have a relevant representation in the adult population in Mexico. RD are characterized by their chronic and progressive nature, which can impact functionality during the disease and can present various factors that can be associated with the presence of abuse, among others, economic dependence, decreased physical capacity, and need for care and support in different health processes.
In 1970, the phenomenon of abuse in geriatric patients was described for the first time as a phenomenon identified as a public health problem and an issue of human rights violation.
In 2012 Giraldo-Rodríguez developed and validated the Geriatric Abuse Scale (GAS), an instrument that, with adequate psychometric properties, reported a prevalence of abuse of 10.28% in Mexico.
Regarding abuse in patients with RD, there is little information in the literature; however, it is possible that the prevalence could be similar to that of the occurrence in older adults since both populations share important states of vulnerability.
The study aimed to identify the prevalence of abuse in patients with RD. The study will be conducted in two phases: the first one in which the GAS will be adapted for patients with RD, and this version will be validated in a population of our Institute, and the second one in which, applying the validated instrument, the magnitude of abuse is evaluated, and the factors associated with this phenomenon among patients with RD are explored.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatic diseases | – | Other: Rheumatic diseases Mistreatment Scale (RDMS), 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: Big Five Inventory, Other: Family APGAR QuestionnaireAll the rheumatic diseases outpatients from the National Institute of Medical Sciences |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the rheumatic diseases outpatients from the National Institute of Medical Sciences
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 |
|---|---|---|
| Rheumatic diseases Mistreatment Scale (RDMS)Also: RD-MSIn 2012 Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS), prior to its application, translation, cultural adaptation, and validation were performed. | Other | Patients with rheumatic diseases |
| Health Assessment Questionnaire (HAQ)Also: HAQThe HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality | Other | Patients with rheumatic diseases |
| Depression, Anxiety and Stress Scale (DASS-21)Also: DASS-21DASS-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 | Patients with rheumatic diseases |
| Brief Resilient Coping ScaleAlso: BRCSBrief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner | Other | Patients with rheumatic diseases |
| 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 | Patients with rheumatic diseases |
| Routine assessment of patient index data 3 (RAPID-3)Also: RAPID-3RAPID- 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 | Patients with rheumatic diseases |
| Big Five InventoryAlso: BFI-10The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness. | Other | Patients with rheumatic diseases |
| Family APGAR QuestionnaireAlso: APGARFamily APGAR questionnaire is used to evaluate family function, in the context of family medical care | Other | Patients with rheumatic diseases |
Primary outcome
Number of Mexican patients with RD who will present the phenomenon of mistreatment
Time frame: At inclusion (baseline moment) (cross-sectional study)
Identify the percentage of patients with rheumatic diseases that present mistreatment using the instrument developed by Giraldo-Rodríguez et al (translation, cultural adaptation, and validation performed)
1 secondary outcome
Identify factors associated with mistreatment among patients with rheumatic diseases
Time frame: At inclusion (baseline moment) (cross-sectional study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 22694594Giraldo-Rodriguez L, Rosas-Carrasco O. Development and psychometric properties of the Geriatric Mistreatment Scale. Geriatr Gerontol Int. 2013 Apr;13(2):466-74. doi: 10.1111/j.1447-0594.2012.00894.x. Epub 2012 Jun 14.
- Background: PubMed 16357732Castro I, Barrantes F, Tuna M, Cabrera G, Garcia C, Recinos M, Espinoza LR, Garcia-Kutzbach A. Prevalence of abuse in fibromyalgia and other rheumatic disorders at a specialized clinic in rheumatic diseases in Guatemala City. J Clin Rheumatol. 2005 Jun;11(3):140-5. doi: 10.1097/01.rhu.0000164823.78761.a2.
- Derived from this study: PubMed 39775374Contreras-Yanez I, Ledon-LLanes L, Guaracha-Basanez GA, Sanchez-Hernandez A, Ortiz-Haro AB, Pascual-Ramos V. Perceived mistreatment in patients with rheumatic diseases: The impact of the underlying diagnosis. PLoS One. 2024 Dec 30;19(12):e0316312. doi: 10.1371/journal.pone.0316312. eCollection 2024.
- 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 Dr Pascual-Ramos principal investigator
INNSZ
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 Abuse Neglect, 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 12 Mar 2024. 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 Ph 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?
Number of Mexican patients with RD who will present the phenomenon of mistreatment (time frame: At inclusion (baseline moment) (cross-sectional study)). 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 NCT06233760, which also lists 3 linked publications.
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 12 Mar 2024.