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Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes
ISRCTN ISRCTN34974819
DOI 10.1186/ISRCTN34974819
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes
Scientific title Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial
Acronym EBAGRAP
Serial number at source Sponsor ref: 01GT0605
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Germany
Disease/condition/study domain Physical restraints in nursing homes
Participants - 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.
Participants - exclusion criteria Nursing homes with less than 20% of residents with physical restraints and less than 60 residents.
Anticipated start date 15/04/2009
Anticipated end date 31/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 36 nursing homes (approximately 3,000 residents)
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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).
Sources of funding 1. German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
2. Northern Germany Nursing Research Network (Germany) (ref: University of Hamburg: 01GT0605, University of Witten/Herdecke: 01GT0808)
Trial website
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19735564
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22618925
Contact name Prof  Gabriele  Meyer
  Address University of Witten/Herdecke
Faculty for Medicine
Institute of Nursing Science
  City/town Witten
  Zip/Postcode 58453
  Country Germany
  Tel +49 (0)2302 926 317
  Fax +49 (0)2302 926 318
  Email Gabriele.Meyer@uni-wh.de
Sponsor German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
  Address Projektträger im DLR
Heinrich-Konen-Strasse 1
  City/town Bonn
  Zip/Postcode 53227
  Country Germany
  Email Diana.Klassen@dlr.de
  Sponsor website: http://www.bmbf.de
Date applied 29/04/2009
Last edited 29/05/2012
Date ISRCTN assigned 29/05/2009
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