Condition category
Not Applicable
Date applied
29/04/2009
Date assigned
29/05/2009
Last edited
29/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bmbf.de

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

  1. 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.

  2. 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.

Additional files

Editorial Notes