Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

244

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

April 1, 2023

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2024

Completed

17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

January 14, 2024

Last Update Submit

March 9, 2024

Conditions

Rheumatic Diseases Abuse Neglect Abuse

Keywords

rheumatic diseasesAbuse

Outcome Measures

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)
At inclusion (baseline moment) (cross-sectional study)

Secondary Outcomes (1)

Identify factors associated with mistreatment among patients with rheumatic diseases
At inclusion (baseline moment) (cross-sectional study)

Study Arms (1)

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 ScaleOther: WHOQOL-BREFOther: Routine assessment of patient index data 3 (RAPID-3)Other: Big Five InventoryOther: Family APGAR Questionnaire

Interventions

Rheumatic diseases Mistreatment Scale (RDMS)OTHER

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