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
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