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Continuing Education in Nursing Home Dementia Care (MEDCED)

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Frode F. Jacobsen, Bergen University College
ClinicalTrials.gov Identifier:
NCT01715506
First received: October 25, 2012
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Dementia
Agitation
Behavioral: Educational intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care

Resource links provided by NLM:


Further study details as provided by Bergen University College:

Primary Outcome Measures:
  • Restraint change [ Time Frame: Assessment in 6-8 months, publication in approximately 18-20 months ] [ Designated as safety issue: No ]
    Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.


Secondary Outcome Measures:
  • Psychotropic drug change [ Time Frame: Assessment in 6-8 months, publication in approximately 18-20 months ] [ Designated as safety issue: No ]
    Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.


Enrollment: 274
Study Start Date: August 2011
Study Completion Date: August 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational intervention
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
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.

Detailed Description:

Purpose:

Dementia is a major challenge for our society. In Norway, around 40 % of persons suffering from dementia live in nursing homes (NH), and the majority experiences severe functional impairments and complex needs including associated behavioral changes. International studies indicate that NH residents with cognitive impairment and high dependency are most likely to be restrained physically. There is evidence of various adverse effects such as injuries, reduced psychological well-being or decreased mobility related to the use of physical restraint. Moreover, in addition to ethical and professional arguments, there is evidence supporting that user-involvement and shared decision-making have positive effects for both residents and staff. The aim of the present study (MEDCED) is to carry out an educational intervention in care staff to test its potential effect on use of restraint in NH residents with dementia and increase job-satisfaction in care staff.

Description:

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.

An analysis of how many units needs to be included are based on 12+12 clusters. Two calculations have been performed. The first calculation is based on how big is the reduction in use of restraints. We assume in our model that there will be a 60 % reduction in use of restraints in the intervention group and 33 % reduction in the control group (Hawthorne effect). For this reason we need to include averagely 13 patients in each department/unit in order to achieve a statistical power of 0,8.

Measures on resident will be collected by a skilled research nurse blind to the study. Care staff measures will be collected through a questionnaire distributed directly to the care staff, provided with a stamped envelope to return the questionnaire directly to the research group. In addition, department characteristics (like type of department, staff coverage, architecture) will be registered.

A research team will lead the EI, and four facilitator teams each consisting of one nurse and one assistant professor from a nursing schools will be responsible for the EI of the decision-making model in the NHs. The Educational intervention will be carried out in two steps, firstly from researchers to the educators (EI 1) and secondly from the educators to the NH staff (EI 2)

  Eligibility

Ages Eligible for Study:   18 Years to 105 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dementia

Exclusion Criteria:

  • non-dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715506

Locations
Norway
Flora Omsorgssenter
Florø, Flora, Norway, 6900
Furuhaugane Omsorgssenter
Florø, Flora, Norway, 6900
Solas bo- og rehabiliteringssenter
Ålgård, Gjesdal, Norway, 4330
Husnestunet
Rosendal, Kvinnherad, Norway, 5470
Rosendalstunet
Rosendal, Kvinnherad, Norway, 5470
Kvitsoy kombisenter
Stavanger, Kvitsoy, Norway, 4180
Luster Sjukeheimsteneste, avd. Gaupne
Sogndal, Luster, Norway, 6868
Samnangerheimen
Bergen, Samnanger, Norway, 5650
Ask bo- og omsorgssenter
Askoy, Norway, 5307
Stiftelsen Nykirkehjemmet
Bergen, Norway, 5005
Landaas Meninghets Eldresenter
Bergen, Norway, 5097
Midtbygda sykehjem
Bergen, Norway, 5873
Teiglandshagen bufellesskap
Bomlo, Norway, 5440
Bygdaheimen
Eidfjord, Norway, 5783
Gulen Sjukeheim
Gulen, Norway, 5966
Laerdal Alders- og Sjukeheim
Laerdal, Norway, 6887
Roldal pleie og omsorgstjeneste
Odda, Norway, 5760
Byhagen Bo og Aktivitetssenter
Sandnes, Norway, 4307
Sogndal Omsorgssenter
Sogndal, Norway, 6856
Bergåstjern Sykehjem
Stavanger, Norway, 4016
Boganes Bokollektiv
Stavanger, Norway, 4032
Oyane Sykehjem
Stavanger, Norway, 4085
Tysnes Sjukeheim
Tysnes, Norway, 5685
Tysvaertunet
Tysvaer, Norway, 5575
Sponsors and Collaborators
Bergen University College
The Research Council of Norway
Investigators
Study Director: Frode F Jacobsen, PhD Bergen University College
  More Information

Responsible Party: Frode F. Jacobsen, Professor, Director, Bergen University College
ClinicalTrials.gov Identifier: NCT01715506     History of Changes
Other Study ID Numbers: 2012/304 
Study First Received: October 25, 2012
Last Updated: July 22, 2016
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Bergen University College:
Dementia
Resident
Nursinghome
Use of restraint
Agitation

Additional relevant MeSH terms:
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016