- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01187732
Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients' (WWW)
WASHING WITHOUT WATER Cost-effectiveness of a Rapidly Spreading Nursing Intervention om Bedridden Patients'
The purpose of this study is to compare the traditional bed bath with 'washing without water' on
- 1) effects on skin integrity
- 2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional bed baths. Bathing regimens are continued for six weeks.
Whereas effects on skin damage are not likely to be specific for setting, these results can be generalized to other patient groups.
Study Overview
Detailed Description
RAPID IMPLEMENTATION of new interventions while cost-effectiveness and acceptability for patients and care providers are unclear, is never desirable. 'Washing without water' is such an intervention.
The traditional bed bath is executed by using tap water, towels, washcloths and soap. As an alternative, 'WASHING WITHOUT WATER' was recently introduced in the Netherlands. This concept consists of disposable washcloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion. 'WASHING WITHOUT WATER' can be used with all patients who need bathing assistance, especially when taking a shower or sitting in a hot tub is not possible.
However, while several claims are made about the positive effects of 'washing without water' as compared to traditional bathing, EVIDENCE IS LACKING. Also, 'washing without water' is CONTROVERSIAL. While some are eager to adopt the new concept, others see it as 'efficiency gone loose' and denying patients one of the most basic elements of care: a proper bath. This study therefore addresses the cost effectiveness of 'washing without water' in bedridden patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud university medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- long stay psychogeriatric nursing home residents
- long stay somatic nursing home residents
- 100 randomly selected nurses from the participating nursing home wards
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Washing without water
The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.
|
The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.
Other Names:
|
ACTIVE_COMPARATOR: Traditional soap and water bath
The control intervention is the traditional bathing assistance as performed in care dependent patients by using tap water, a bowl, towels, washcloths and soap.
|
The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the primary outcome is prevalence of care associated skin damage
Time Frame: 6 weeks
|
Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and nurse satisfaction with bathing technique
Time Frame: 6 weeks
|
|
6 weeks
|
Cost bathing
Time Frame: 6 weeks
|
Bathing and skin damage associated costs will be calculated from the costs of bathing and skin care associated staff time and the materials used.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Theo van Achterberg, PhD, Radboud university medical center; IQ healthcare
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80-82310-97-1074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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