Siderails as a Measure of Physical Restraint. GERBAR Trial

NCT04861025 | Completed

• 1 other identifier: CSAPG-19
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

There is a controversy about if siderails should be considered as a method of physical restraint in older hospitalized patients. This study aims to investigate the opinion of older patients and health professionals about this controversy.

Conditions

Restraint, Physical; Aged; Aged, 80 and Over; Patient Safety

Outcome Measures

Primary Outcomes (2)

• Proportion of patients considering siderails as a physical restraint method

  Proportion of older patients (regard to all of hospitalized older patients) who consider siderails as a physical restraint's method

  Baseline

• Proportion of health professionals considering siderails as a physical restraint method

  Proportion of health professionals (regard to all health professionals working at the hospital) who consider siderails as a physical restraint's method

  Baseline

Secondary Outcomes (2)

• Factors associated to prescription of siderails by health professionals

  Hospital discharge (assessed up to day 180)

• Factors associated to prescription of siderails by hospitalized patients

  Hospital discharge (assessed up to day 180)

Study Arms (2)

Users Group

Patients admitted to any Hospitalization Unit belonging to Geriatrics Department

Health Professionals Group

All health professionals working at some Hospitalization Unit belonging to CSAPG Institution

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All older patients admitted to Hospitalization Units belonging to Geriatrics Department. All health professionals working at a Secondary Care Center.

You may qualify if:

• Group 1 (Healthcare professionals):
• a. Any health professional (nursing assistant, nurse, doctor...) who belons to CSAPG Institution.
• Group 2 (Users):
• Patient aged 65 or more years admitted to one of the participating Hospitalization Units belonging to Geriatrics Department.

You may not qualify if:

• Group 1 (Healthcare professionals):
• a. Refusal to participate in the study.
• Group 2 (Users):
• Users in palliative sedation or with short /very short life expectancy.
• Inability to consent and absence of a legal representative.
• Refusal to participate in the study.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari d'Alt Penedès i Garraf

Sant Pere de Ribes, Barcelona, 08880, Spain

Location

Related Publications (2)

• Macho-Perez O, Arroyo-Huidobro M, Gimenez Buendia MDC, Galvez-Barron C. [Does the healthcare user consider rails as physical subjugation?]. Rev Esp Geriatr Gerontol. 2021 Jan-Feb;56(1):59-60. doi: 10.1016/j.regg.2020.06.008. Epub 2020 Oct 17. No abstract available. Spanish.

  PMID: 33081978 BACKGROUND

• Galvez-Barron C, Gonzalez-De Luna A, Perez-Lopez C, Macho-Perez O. Cross-sectional survey of healthcare professionals' perceptions of bedrails as a measure of physical restraint in the hospital setting. Age Ageing. 2025 Jan 6;54(1):afaf002. doi: 10.1093/ageing/afaf002.

  PMID: 39851241 RESULT

Study Officials

• Oscar Macho Perez, MD

  Consorci Sanitari d'Alt Penedès i Garraf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)