Contact information
Type
Scientific
Primary contact
Prof Gabriele Meyer
ORCID ID
Contact details
University of Witten/Herdecke
Faculty for Medicine
Institute of Nursing Science
Witten
58453
Germany
+49 (0)2302 926 317
Gabriele.Meyer@uni-wh.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Sponsor ref: 01GT0605
Study information
Scientific title
Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial
Acronym
EBAGRAP
Study hypothesis
The purpose of this study is to evaluate the clinical efficacy and safety of an intervention programme based on an evidence-based guidance on the reduction of physical restraints in nursing homes. We are specifically interested in whether the intervention can reduce the number of residents with at least one physical restraint at six months of follow-up.
Ethics approval
1. Ethics Committee of the Hamburg Chamber of Physicians approved on the 8th April 2009 (ref: PV3165)
2. Ethics Committee of the University of Witten/Herdecke approved on the 24th April 2009
Study design
Cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Physical restraints in nursing homes
Intervention
The intervention is based on an evidence-based guidance on the reduction of physical restraints in nursing homes, comprising 24 statements on relevant interventions to avoid physical restraints. The intervention consists of a structured single information session of approximately 90 minutes for all nursing staff, provision of written information material for nurses, legal guardians and residents' relatives and a one-day training workshop for nominated nurses of each cluster, who will be responsible for all issues concerning physical restraints. Nurses in charge of the control group receive personal and written brief standard information on legal and scientific evidence on physical restraints and alternatives aimed to avoid measures.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of residents with at least one physical restraint after six months of follow-up. Physical restraints are defined as any device, material or equipment attached to or near a person's body, which cannot be controlled easily or removed by the person and which deliberately prevents or is deliberately intended to prevent a person's free body movement to a position of choice. Prevalence data of physical restraints will be obtained by direct observation on three occasions on one day (morning, noon, evening) by trained external investigators, who are blinded to allocation of nursing homes. Data will be collected before randomisation, after three and after six months using a proven data collection instrument of a previous epidemiological study.
Secondary outcome measures
The number of falls and fall-related fractures. Nursing staff will document fall events within their in-house documentation system throughout the whole study period. If no documentation sheet for fall events exists it will be provided by the researchers. Data will be collected throughout the study period (6 months).
Overall trial start date
15/04/2009
Overall trial end date
31/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Nursing homes in the city of Hamburg and in surrounding cities of Witten/Herdecke with at least 20% of residents with physical restraints and at least 60 residents. All residents will be included.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
36 nursing homes (approximately 3,000 residents)
Participant exclusion criteria
Nursing homes with less than 20% of residents with physical restraints and less than 60 residents.
Recruitment start date
15/04/2009
Recruitment end date
31/05/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University of Witten/Herdecke
Witten
58453
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Projektträger im DLR
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
Diana.Klassen@dlr.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Northern Germany Nursing Research Network (Germany) (ref: University of Hamburg: 01GT0605, University of Witten/Herdecke: 01GT0808)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19735564
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22618925
Publication citations
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Results
Köpke S, Mühlhauser I, Gerlach A, Haut A, Haastert B, Möhler R, Meyer G, Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial., JAMA, 2012, 307, 20, 2177-2184, doi: 10.1001/jama.2012.4517.
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Haut A, Köpke S, Gerlach A, Mühlhauser I, Haastert B, Meyer G, Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819]., BMC Geriatr, 2009, 9, 42, doi: 10.1186/1471-2318-9-42.