Aging Clinical Trial
— CHAMPsOfficial 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
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | October 31, 2026 |
Est. primary completion date | May 15, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. > 65 years of age, 2. Admitted to a medical-surgical unit, 3. Expected to be hospitalized for more than 24 hours, 4. Written informed consent within 24-48 hours of admission, and 5. Speak and read English 6. Physical capacity to use the CHAMPs system 7. Sufficient hearing and seeing capacity to indicate understanding and use of the intervention. Exclusion Criteria 1. terminal illness that prohibit interaction with CHAMPs 2. behavior disorder 3. violent behavior 4. physical or cognitive impairments that prohibit interaction with CHAMPs 5. limiting understanding and use of CHAMPs 6. undergoing radiation or chemotherapy that prohibit interaction with CHAMPs 7. skin disorders or 8. broken skin on hands. |
Country | Name | City | State |
---|---|---|---|
United States | Lous Stokes Cleveland VA Medical Center | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | Louis Stokes VA Medical Center, MetroHealth Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Hand Contamination Presence/Absence with Select Pathogens at Baseline | The primary effect of interest is that of the CHAMPs intervention on hand contamination at day 3-4 of study stay. The research study staff will test the presence/absence of hand contamination using a test of proportions that compares the two study arms using a two-sided test with an a = 0.05. > 1 colony forming unit of the following organisms susceptible to hand sanitizer: Enterobacteriaceae, Enterococci, Staphylococcus aureus, and Yeastis indicative of presence whereas 0 is indicative of absence. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies*dilution factor) / volume of culture plate. | Day 0 | |
Primary | Patient Hand Contamination Presence/Absence with Select Pathogens at Day 3-4 | The primary effect of interest is that of the CHAMPs intervention on hand contamination at day 3-4 of study stay. The research study staff will test the presence/absence of hand contamination using a test of proportions that compares the two study arms using a two-sided test with an a = 0.05. > 1 colony forming unit of the following organisms susceptible to hand sanitizer: Enterobacteriaceae, Enterococci, Staphylococcus aureus, and Yeastis indicative of presence whereas 0 is indicative of absence. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies*dilution factor) / volume of culture plate. | Day 3 or 4 | |
Primary | Patient Hand Contamination Counts of Pathogens at Baseline | The secondary effect retrieved after accomplishing presence or absence is the number of colony forming units (CFU) counts of pathogens. Participants with superior hand hygiene should have less multidrug-resistant organisms on their hands as measured by colony forming units when comparing baseline to the day 3-4 collection of hand swabs. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies*dilution factor) / volume of culture plate. | Day 0 | |
Primary | Patient Hand Contamination Counts of Pathogens at Day 3-4 | The secondary effect retrieved after accomplishing presence or absence is the number of colony forming units (CFU) counts of pathogens. Participants with superior hand hygiene should have less multidrug-resistant organisms on their hands as measured by colony forming units when comparing baseline to the day 3-4 collection of hand swabs. Colony forming units, or CFUs, are a unit of measurement used to determine the number of bacterial cells in a probiotic supplement or lab sample. CFU/ml is equal to the total number of colonies multiplied by the dilution factor and this is divided by the volume of the culture plate. CFU/ml - (Number of colonies*dilution factor) / volume of culture plate. | Day 3 or 4 | |
Secondary | Patient Hand Hygiene Practice at Baseline | Secondary measure of hand hygiene practice will be indicated by hand sanitizer volume used. The bottle of hand sanitizer will be weighed before and after in milligrams (mg). Substracting the end weight from the baseline weight (mg) provides the weight which will then be converted into the difference in volume used. The equivalent of 1 Milligrams (mg) measurement of weight is equivalent to 1 Milliliters (ml) measurement of volume of liquid. The final measurement will be reported in milliliters (ml). Higher use of hand sanitizer volume indicates increased practice. | Day 0 | |
Secondary | Patient Hand Hygiene Practice at Day 3-4 | Secondary measure of hand hygiene practice will be indicated by hand sanitizer volume used. The bottle of hand sanitizer will be weighed before and after in milligrams (mg). Substracting the end weight from the baseline weight (mg) provides the weight which will then be converted into the difference in volume used. The equivalent of 1 Milligrams (mg) measurement of weight is equivalent to 1 Milliliters (ml) measurement of volume of liquid. The final measurement will be reported in milliliters (ml). Higher use of hand sanitizer volume indicates increased practice. | Day 3 or 4 |
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