Prevalence of Abuse Among Patients With Rheumatic Diseases

Rheumatic Diseases Clinical Trial

Official title:

Prevalence of Abuse Among Patients With Rheumatic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233760
• Other study ID #: IRE3234
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: March 2, 2026

Study information

• Verified date: March 2024
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: Virginia Ph Pascual-Ramos
• Phone: 525555734111
• Email: virtichu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: March 2, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Abuse
• Abuse Neglect
• Collagen Diseases
• Rheumatic Diseases

Intervention

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.
• Health Assessment Questionnaire (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)
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 Scale
Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner
• 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
• 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
• Big Five Inventory
The BFI-10 is a 10-item scale measuring the Big Five personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
• Family APGAR Questionnaire
Family APGAR questionnaire is used to evaluate family function, in the context of family medical care

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At inclusion (baseline moment) (cross-sectional study)
Secondary	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	At inclusion (baseline moment) (cross-sectional study)