Prevalence of Abuse Among Patients With Rheumatic Diseases

NCT ID: NCT06233760

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-03-02

Brief Summary

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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

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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

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Rheumatic Diseases Abuse Neglect Abuse

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with rheumatic diseases

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

Rheumatic diseases Mistreatment Scale (RDMS)

Intervention Type OTHER

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)

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner

WHOQOL-BREF

Intervention Type OTHER

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)

Intervention Type OTHER

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

Intervention Type OTHER

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

Family APGAR Questionnaire

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Health Assessment Questionnaire (HAQ)

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Intervention Type OTHER

Family APGAR Questionnaire

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

Intervention Type OTHER

Other Intervention Names

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RD-MS HAQ DASS-21 BRCS RAPID-3 BFI-10 APGAR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Virginia Pascual Ramos

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginia Dr Pascual-Ramos

Role: PRINCIPAL_INVESTIGATOR

INNSZ

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Virginia Ph Pascual-Ramos

Role: CONTACT

525555734111 ext. 533

Virginia Dr Pascual-Ramos

Role: CONTACT

525555734111 ext. 533

Facility Contacts

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Virginia Pascual-Ramos, MD

Role: primary

00525555734111 ext. 533

References

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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.

Reference Type BACKGROUND
PMID: 22694594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16357732 (View on PubMed)

Other Identifiers

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IRE3234

Identifier Type: -

Identifier Source: org_study_id

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