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Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients' (WWW)

Primary Purpose

Skin Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Washing without water
Sponsored by
Betsie van Gaal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Disease focused on measuring skin damage, intertrigo, dermatitis, erythema, aggression, body Wipes, soaps, no rinse, cost effectiveness, nursing home residents, nurse

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Washing without water

Traditional soap and water bath

Arm Description

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 control intervention is the traditional bathing assistance as performed in care dependent patients by using tap water, a bowl, towels, washcloths and soap.

Outcomes

Primary Outcome Measures

the primary outcome is prevalence of care associated skin damage
Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.

Secondary Outcome Measures

Patient and nurse satisfaction with bathing technique
patient perceived discomfort during bathing nurse perceived work load observed bathing quality
Cost bathing
Bathing and skin damage associated costs will be calculated from the costs of bathing and skin care associated staff time and the materials used.

Full Information

First Posted
August 23, 2010
Last Updated
April 24, 2017
Sponsor
Betsie van Gaal
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01187732
Brief Title
Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'
Acronym
WWW
Official Title
WASHING WITHOUT WATER Cost-effectiveness of a Rapidly Spreading Nursing Intervention om Bedridden Patients'
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Betsie van Gaal
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Disease
Keywords
skin damage, intertrigo, dermatitis, erythema, aggression, body Wipes, soaps, no rinse, cost effectiveness, nursing home residents, nurse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Washing without water
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional soap and water bath
Arm Type
Active Comparator
Arm Description
The control intervention is the traditional bathing assistance as performed in care dependent patients by using tap water, a bowl, towels, washcloths and soap.
Intervention Type
Device
Intervention Name(s)
Washing without water
Other Intervention Name(s)
bag baths, disposable washing cloths
Intervention Description
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.
Primary Outcome Measure Information:
Title
the primary outcome is prevalence of care associated skin damage
Description
Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Patient and nurse satisfaction with bathing technique
Description
patient perceived discomfort during bathing nurse perceived work load observed bathing quality
Time Frame
6 weeks
Title
Cost bathing
Description
Bathing and skin damage associated costs will be calculated from the costs of bathing and skin care associated staff time and the materials used.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theo van Achterberg, PhD
Organizational Affiliation
Radboud university medical center; IQ healthcare
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25173772
Citation
Schoonhoven L, van Gaal BG, Teerenstra S, Adang E, van der Vleuten C, van Achterberg T. Cost-consequence analysis of "washing without water" for nursing home residents: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):112-20. doi: 10.1016/j.ijnurstu.2014.08.001. Epub 2014 Aug 10.
Results Reference
derived

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Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'

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