Condition category
Mental and Behavioural Disorders
Date applied
18/04/2008
Date assigned
12/06/2008
Last edited
12/06/2008
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

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 measures

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

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

http://www.umu.se/umu/index_eng.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes