NCT01715506

Brief Summary

This is a single-blinded controlled cluster-randomized intervention trial recruiting staff from 24 NHs in three counties in the region of Western Norway, randomly selected from the total NH population in the region. A cluster is defined as a working ward of a larger NH, without shared facilities or staff. The 24 NHs are randomized into two groups, for intervention (12) and control (12). One department in each is selected for intervention and data collection will take place also in one department in each of the NHs in the control group. Hence the analyzed units (clusters) are NH departments. The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. A seven-month educational intervention will be performed, and due to ethical issues the control group will receive the same intervention after the second follow-up. Effects will be measured on resident and care staff level at baseline before randomization, after the intervention (7 months) and at follow-up (7 months later) of the intervention group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

October 25, 2012

Last Update Submit

July 22, 2016

Conditions

Keywords

DementiaResidentNursinghomeUse of restraintAgitation

Outcome Measures

Primary Outcomes (1)

  • Restraint change

    Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.

    Assessment in 6-8 months, publication in approximately 18-20 months

Secondary Outcomes (1)

  • Psychotropic drug change

    Assessment in 6-8 months, publication in approximately 18-20 months

Study Arms (1)

Educational intervention

EXPERIMENTAL

Educational intervention with two days of lecture/course for the whole staff in the selected department in each nursing home and six monthly sessions of counselling in smaller groups

Behavioral: Educational intervention

Interventions

The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. Course material, a book particularly designed for this intervention and dealing with person centered care and use of restraint, is distributed ahead of the course part of the intervention to all participants.

Educational intervention

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dementia

You may not qualify if:

  • non-dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Flora Omsorgssenter

Florø, Flora, 6900, Norway

Location

Furuhaugane Omsorgssenter

Florø, Flora, 6900, Norway

Location

Solas bo- og rehabiliteringssenter

Ålgård, Gjesdal, 4330, Norway

Location

Husnestunet

Rosendal, Kvinnherad, 5470, Norway

Location

Rosendalstunet

Rosendal, Kvinnherad, 5470, Norway

Location

Kvitsoy kombisenter

Stavanger, Kvitsoy, 4180, Norway

Location

Luster Sjukeheimsteneste, avd. Gaupne

Sogndal, Luster, 6868, Norway

Location

Samnangerheimen

Bergen, Samnanger, 5650, Norway

Location

Ask bo- og omsorgssenter

Askoy, 5307, Norway

Location

Stiftelsen Nykirkehjemmet

Bergen, 5005, Norway

Location

Landaas Meninghets Eldresenter

Bergen, 5097, Norway

Location

Midtbygda sykehjem

Bergen, 5873, Norway

Location

Teiglandshagen bufellesskap

Bømlo, 5440, Norway

Location

Bygdaheimen

Eidfjord, 5783, Norway

Location

Gulen Sjukeheim

Gulen, 5966, Norway

Location

Laerdal Alders- og Sjukeheim

Lærdal, 6887, Norway

Location

Roldal pleie og omsorgstjeneste

Odda, 5760, Norway

Location

Byhagen Bo og Aktivitetssenter

Sandnes, 4307, Norway

Location

Sogndal Omsorgssenter

Sogndal, 6856, Norway

Location

Bergåstjern Sykehjem

Stavanger, 4016, Norway

Location

Boganes Bokollektiv

Stavanger, 4032, Norway

Location

Oyane Sykehjem

Stavanger, 4085, Norway

Location

Tysnes Sjukeheim

Tysnes, 5685, Norway

Location

Tysvaertunet

Tysvær, 5575, Norway

Location

Related Publications (1)

  • Jacobsen FF, Mekki TE, Forland O, Folkestad B, Kirkevold O, Skar R, Tveit EM, Oye C. A mixed method study of an education intervention to reduce use of restraint and implement person-centered dementia care in nursing homes. BMC Nurs. 2017 Sep 18;16:55. doi: 10.1186/s12912-017-0244-0. eCollection 2017.

MeSH Terms

Conditions

DementiaPsychomotor Agitation

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Frode F Jacobsen, PhD

    Bergen University College

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations