Prevalence of Abuse Among Patients With Rheumatic Diseases

March 9, 2024 updated by: Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Virginia Ph Pascual-Ramos
  • Phone Number: 533 525555734111
  • Email: virtichu@gmail.com

Study Contact Backup

  • Name: Virginia Dr Pascual-Ramos
  • Phone Number: 533 525555734111
  • Email: virtichu@gmail.com

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with a not confirmed rheumatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rheumatic diseases
All the rheumatic diseases outpatients from the National Institute of Medical Sciences
Other: Health Assessment Questionnaire (HAQ)
The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality
Other Names:
  • HAQ
Other: 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 Names:
  • DASS-21
Other: Brief 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
Other Names:
  • BRCS
Other: WHOQOL-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
Other: 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 Names:
  • RAPID-3
Other: Rheumatic 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.
Other Names:
  • RD-MS
Other: Big Five Inventory
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
Other Names:
  • BFI-10
Other: Family APGAR Questionnaire
Family APGAR questionnaire is used to evaluate family function, in the context of family medical care
Other Names:
  • APGAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At inclusion (baseline moment) (cross-sectional study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify factors associated with mistreatment among patients with rheumatic diseases
Time Frame: At inclusion (baseline moment) (cross-sectional study)
Identify factors associated with mistreatment among patients with rheumatic diseases using an instrument locally development
At inclusion (baseline moment) (cross-sectional study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • Principal Investigator: Virginia Dr Pascual-Ramos, INNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 2, 2026

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRE3234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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