Contact information
Type
Scientific
Primary contact
Dr Stig Karlsson
ORCID ID
Contact details
Umeå University
Umeå
SE-90187
Sweden
+46 90 7869259
stig.karlsson@nurs.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
It is hypothesised that an educational intervention in group dwellings for persons with dementia will increase staff knowledge about and change their attitudes towards the use of physical restraints. This will lead to a reduction in physical restraints use which in turn will have an positive effect on staffs' perceived job strain.
Ethics approval
Ethics Committee of the Medical Faculty of Umeå University. Date of approval: 12/03/2002 (ref: Section 92/02, dnr 02-105)
Study design
Cluster randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Use of physical restraints in group dwellings.
Intervention
The intervention consisted of an education programme for the nursing staff (registered nurses, licensed practical nurses and nurse aid). The content of the programme included dementia diseases, symptoms, treatment and related complications, fall prevention, prevention and treatment of delirium, interaction and communication in dementia care and negative effects of, alternatives to and legislation directing the use of physical restraints.
First, the head-nurse at each intervention unit selected one person who underwent the whole education programme compressed during two seminar days. Remaining staff received their education via 30-minute videotaped lectures. Three of the lectures also included a clinical written vignettes forming the basis for group discussions. At each unit it was up to the staff to make arrangements for watching the films and if desired to arrange group discussions. Each unit was responsible for making arrangements for taking part of the lectures and if desired to arrange group discussions. The education programme ran alongside ordinary work at the units without further involvement of the researchers besides distribution of the video taped lectures and data collection. In the education programme the emphasis was on the importance of investigating the underlying causes instead of working in a symptom-oriented manner e.g. a resident that have sustained a fall accident should be investigated for the cause of the fall instead of just using physical restraints. The staff was encouraged to use physical restraints only as the last resort. The intervention/education programme was carried out over six months.
The control units did not receive any interventions during the study period; they did receive interventions after the study was completed.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Residents:
1. Physical restraints were recorded daily for each patient, for three weeks before interventions, and then until the end of interventions (6 months). The information recorded include type of physical restraints used, hours restrained and reasons for restraining.
Outcomes concerning staff, measured before interventions and at 6 months:
1. Staff knowledge about current legislation, measured by a seven-item index score ranging between 0-7 (higher values indicate higher knowledge)
2. Staff subjective knowledge relating to care of people with dementia, measured by a visual analogue scale (VAS)
3. Staff attitudes, measured by the 17-item Perceptions of Restraint Use Questionnaire (PRUQ)
4. Job strain, measured by three instruments:
4.1. The Job-Demand and Social Support Questionnaire
4.2. Stress of Conscience Questionnaire
4.3. Caring climate, measured by a VAS
Secondary outcome measures
Outcomes concerning residents:
1. Fall accidents, recorded during the whole study period (8 months [1 month prior to interventions, 6 months during interventions and 1 month after interventions)
2. Psychoactive drug use, assessed before interventions and at 6 months
3. Motor function, vision, hearing and speech, assessed by the Multi-Dimensional Dementia Assessment Scale (MDDAS) before interventions and at 6 months. MDDAS included the Activity of Daily Living (ADL) functions and behavioural and psychiatric symptoms questionnaire. Gottfries cognitive level questionnaire (subscale to the MDDAS) was used for the measurement of cognitive level.
Staff characteristics:
4. Demography
5. Education level
6. Years worked
7. Evaluation of the intervention, carried out within one week after the end of intervention
Overall trial start date
01/02/2005
Overall trial end date
01/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Residents (both men and women) living in group dwellings for persons with dementia, which have at least 20% of the residents restrained.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
320 residents
Participant exclusion criteria
Units with less than 20% of the residents restrained.
Recruitment start date
01/02/2005
Recruitment end date
01/06/2006
Locations
Countries of recruitment
Sweden
Trial participating centre
Umeå University
Umeå
SE-90187
Sweden
Sponsor information
Organisation
Umeå University (Sweden)
Sponsor details
Umeå
-
SE-90187
Sweden
+46 90 7869259
stig.karlsson@nurs.umu.se
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Lions Research Foundation for Age Related Diseases (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
King Gustaf V's and Queen Victoria's Freemason Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Field Research Centre for the Elderly in Västerbotten (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedisch Research Council (Grant ref: K2005-27-VX-15357-01A)(Sweden)
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
Basic results (scientific)
Publication list