Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT05866393
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clean Hands Accessible and Manageable for Patients (CHAMPs)
Sponsor:
Case Western Reserve University
Organization:
Study Overview
Official Title:
Clean Hands Accessible and Manageable for Patients (CHAMPs): A Technology-based Self-management Intervention to Improve Patient Hand Hygiene and Reduce Hand Contamination Among Older Adults
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMPs
Brief Summary:
This study proposes the novel use of a bedrail-affixed technology-based patient hand hygiene system with verbal and visual reminders to improve hospitalized older adults' self-management of hand hygiene practice, which in return reduces harmful germs found on older adult's hands that lead to infections.
Detailed Description:
The investigators long-term goal to establish sustainable, patient-centered interventions at the patient level to engage patients in safety and prevention by offsetting barriers such as physical and sensory limitations that prohibit older adults from actively cleaning their hands independently. Unfortunately, older adults are at highest risk for infections and yet while hand hygiene is the single most important way to prevent the spread of infection, mechanisms for older adults to minimize personal risk for infections is often overlooked. Many contamination elements exist in hospital settings and for older adults encountering high-touch surfaces and medical devices that harbor pathogens that lead to infections will occur. However, without assistance, hand-hygiene practice rates are poor among hospitalized older adults' due to frailty, limited dexterity and mobility, cognitive limitations, and risk of falling, which prohibits independent use of visible hand- hygiene products (e.g., wall dispensers, towelettes, in-room sinks). New solutions are necessary. Therefore, in this proposal, the investigators have updated this investigator-developed, technology-enhanced patient hand hygiene system. Clean Hands Accessible and Manageable for Patients (CHAMPs), the investigator-developed and pilot tested bed rail-affixed hand-sanitizing dispenser, which features verbal, auditory and visual reminders to remind patients to sanitize hands. The safe and easily accessible motion-sensing system with usage tracking requires very little physical effort, as users need only to be able to freely move upper extremities and reach over to the bed rail to clean hands when prompted (e.g. before meal times). Pilot results among both a small group of older adults and in a high-tech simulated environment demonstrated both efficacy and feasibility of the intervention. In this 4-year project, the investigators propose a large heterogeneous randomized controlled trial (RCT) comparing two groups of hospitalized adults ≥ 65 years in two public hospitals, one group receives CHAMPs (n=125) and the other is the usual-care (UC) group (n=125). Study investigators consists of early and late stage investigators who have a successful record of working together and are ready to address the following aims: (1) to determine the effect of CHAMPs as a method to improve hand hygiene behavior and reduce patients' hand contamination, (2) assess the implementation of the intervention and (3) examine factors that influence outcomes associated with the intervention. The primary outcome is hand contamination as measured by presence, type, and quantity of colony forming units located on participants' hands. The research study staff's preliminary results offer promise that the CHAMPs technology-enhanced intervention may be an effective approach to engage patients in infection prevention as a solution to reduce colonization and infection rates among older adults.This proposal aligns with all four goals of NIH/NIA's 2020-2025 strategic plan, which is to improve the health, well-being, and independence of adults as age increases and to prevent or reduce the burden of age-related diseases, disorders, and disabilities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: