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RecruitingNCT06233760Updated Mar 12, 2024

Prevalence of Abuse Among Patients With Rheumatic Diseases

An observational study in Rheumatic Diseases, Abuse Neglect and Abuse, 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. Per ClinicalTrials.gov, last updated 2024-03-12.

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

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
244
Ages
18 Years to 100 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Rheumatic Diseases
  • Abuse Neglect
  • Abuse

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Keywords

  • rheumatic diseases
  • Abuse
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 244 is close to 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
No
Sampling method
Probability sample

Study population

All the rheumatic diseases outpatients from the National Institute of Medical Sciences

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

  • Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion criteria

Exclusion Criteria:

  • Patients with a not confirmed rheumatic disease
05

Study design

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

Groups and cohorts

  • Patients with rheumatic diseases

    All the rheumatic diseases outpatients from the National Institute of Medical Sciences

    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

Interventions

  • OtherRheumatic diseases Mistreatment Scale (RDMS)

    In 2012 Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS), prior to its application, translation, cultural adaptation, and validation were performed.

    Also known as: RD-MS

  • OtherHealth Assessment Questionnaire (HAQ)

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

    Also known as: HAQ

  • 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

    Also known as: DASS-21

  • 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

    Also known as: BRCS

  • 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

    Also known as: RAPID-3

  • OtherBig Five Inventory

    The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.

    Also known as: BFI-10

  • OtherFamily APGAR Questionnaire

    Family APGAR questionnaire is used to evaluate family function, in the context of family medical care

    Also known as: APGAR

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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

    Time frame: At inclusion (baseline moment) (cross-sectional study)

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 22694594 ↗
  • Castro 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 16357732 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06233760
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 31, 2024
Start date
Apr 1, 2023
Primary completion
Feb 1, 2025 (estimated)
Completion
Mar 2, 2026 (estimated)
Last update
Mar 12, 2024

Study contacts

Virginia Ph Pascual-Ramos
Contact
virtichu@gmail.com
525555734111 ext. 533
Virginia Dr Pascual-Ramos
Contact
virtichu@gmail.com
525555734111 ext. 533
Virginia Dr Pascual-Ramos
principal investigator · INNSZ

Oversight

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

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