Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-29 @ 12:09 AM
Study NCT ID:
NCT01187732
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007402', 'term': 'Intertrigo'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D004890', 'term': 'Erythema'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the primary outcome is prevalence of care associated skin damage', 'timeFrame': '6 weeks', 'description': 'Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.'}], 'secondaryOutcomes': [{'measure': 'Patient and nurse satisfaction with bathing technique', 'timeFrame': '6 weeks', 'description': '* patient perceived discomfort during bathing\n* nurse perceived work load\n* observed bathing quality'}, {'measure': 'Cost bathing', 'timeFrame': '6 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['skin damage', 'intertrigo', 'dermatitis', 'erythema', 'aggression', 'body Wipes', 'soaps', 'no rinse', 'cost effectiveness', 'nursing home residents', 'nurse'], 'conditions': ['Skin Disease']}, 'referencesModule': {'references': [{'pmid': '25173772', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the traditional bed bath with 'washing without water' on\n\n* 1\\) effects on skin integrity\n* 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.\n\nWhereas effects on skin damage are not likely to be specific for setting, these results can be generalized to other patient groups.", 'detailedDescription': "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.\n\nThe 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.\n\nHowever, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* long stay psychogeriatric nursing home residents\n* long stay somatic nursing home residents\n* 100 randomly selected nurses from the participating nursing home wards\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01187732', 'acronym': 'WWW', 'briefTitle': "Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "WASHING WITHOUT WATER Cost-effectiveness of a Rapidly Spreading Nursing Intervention om Bedridden Patients'", 'orgStudyIdInfo': {'id': '80-82310-97-1074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Washing without water', '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.", 'interventionNames': ['Device: Washing without water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional soap and water bath', '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.', 'interventionNames': ['Device: Washing without water']}], 'interventions': [{'name': 'Washing without water', 'type': 'DEVICE', 'otherNames': ['bag baths', 'disposable washing cloths'], '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.", 'armGroupLabels': ['Traditional soap and water bath', 'Washing without water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud university medical center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Theo van Achterberg, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud university medical center; IQ healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betsie van Gaal', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Betsie van Gaal', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}