Condition category
Mental and Behavioural Disorders
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
22/06/2006
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

Ms Anna Huizing

ORCID ID

Contact details

University Maastricht (UM)
Department of Health Care Studies
Section of Nursing Science
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881545
a.huizing@zw.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

It is hypothesized that an educational intervention will lead to a reduction of restraint use in psycho-geriatric nursing home residents.

Ethics approval

Not provided at time of registration

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Physical restraint use

Intervention

The educational intervention consists of an educational programme combined with consultation with a nurse specialist. The educational intervention is designed to comply with the decision-making process concerning restraint use defined in a Dutch guideline for restraint use in care situations and to cause nurses to embrace a philosophy of restraint-free care and be familiar with techniques of individualized care. Nurses in the experimental group attended the educational programme on restraint use. Furthermore, consultation with a nurse specialist was introduced on the experimental wards. There was no educational intervention in the control group and residents received the normal care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Restraint prevalence: the percentage of residents observed restrained at any time during the 24-hour period
2. Restraint intensity: the number of times in four observations that a particular resident is restrained
3. Restraint types: restraint types used in residents
4. Multiple restraint: the number of different restraint types used per resident recorded during the four observations

Secondary outcome measures

1. Residents' characteristics, like demographic characteristics, cognitive status, self performance in activities of daily living, mobility, fall incidence, fall-related injuries and psycho-active drug use
2. Organisational characteristics, like workload of nurses and staffing level on the wards

Overall trial start date

01/09/2003

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Psycho-geriatric nursing home residents

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

400

Participant exclusion criteria

Nursing home residents suffering from Korsakov’s disease or psychiatric diseases are excluded

Recruitment start date

01/09/2003

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University of Maastricht (UM) (The Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Maastricht (UM), Province of Limburg, The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Meander Care Group (Zorggroep Meander Oostelijk Zuid-Limburg, the Netherlands)

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

Publication citations

Additional files

Editorial Notes