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Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes

Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34974819
Enrollment
3000
Registered
2009-05-29
Start date
2009-04-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical restraints in nursing homes Not Applicable

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 i

Sponsors

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Nursing homes with less than 20% of residents with physical restraints and less than 60 residents.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026