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Continuing Education in Nursing Home Dementia Care (MEDCED)

Primary Purpose

Dementia, Agitation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Bergen University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, Resident, Nursinghome, Use of restraint, Agitation

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dementia

Exclusion Criteria:

  • non-dementia

Sites / Locations

  • Flora Omsorgssenter
  • Furuhaugane Omsorgssenter
  • Solas bo- og rehabiliteringssenter
  • Husnestunet
  • Rosendalstunet
  • Kvitsoy kombisenter
  • Luster Sjukeheimsteneste, avd. Gaupne
  • Samnangerheimen
  • Ask bo- og omsorgssenter
  • Stiftelsen Nykirkehjemmet
  • Landaas Meninghets Eldresenter
  • Midtbygda sykehjem
  • Teiglandshagen bufellesskap
  • Bygdaheimen
  • Gulen Sjukeheim
  • Laerdal Alders- og Sjukeheim
  • Roldal pleie og omsorgstjeneste
  • Byhagen Bo og Aktivitetssenter
  • Sogndal Omsorgssenter
  • Bergåstjern Sykehjem
  • Boganes Bokollektiv
  • Oyane Sykehjem
  • Tysnes Sjukeheim
  • Tysvaertunet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Restraint change
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
Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.

Full Information

First Posted
October 25, 2012
Last Updated
July 22, 2016
Sponsor
Bergen University College
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT01715506
Brief Title
Continuing Education in Nursing Home Dementia Care
Acronym
MEDCED
Official Title
Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bergen University College
Collaborators
The Research Council of Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Agitation
Keywords
Dementia, Resident, Nursinghome, Use of restraint, Agitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Restraint change
Description
Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.
Time Frame
Assessment in 6-8 months, publication in approximately 18-20 months
Secondary Outcome Measure Information:
Title
Psychotropic drug change
Description
Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.
Time Frame
Assessment in 6-8 months, publication in approximately 18-20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dementia Exclusion Criteria: non-dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frode F Jacobsen, PhD
Organizational Affiliation
Bergen University College
Official's Role
Study Director
Facility Information:
Facility Name
Flora Omsorgssenter
City
Florø
State/Province
Flora
ZIP/Postal Code
6900
Country
Norway
Facility Name
Furuhaugane Omsorgssenter
City
Florø
State/Province
Flora
ZIP/Postal Code
6900
Country
Norway
Facility Name
Solas bo- og rehabiliteringssenter
City
Ålgård
State/Province
Gjesdal
ZIP/Postal Code
4330
Country
Norway
Facility Name
Husnestunet
City
Rosendal
State/Province
Kvinnherad
ZIP/Postal Code
5470
Country
Norway
Facility Name
Rosendalstunet
City
Rosendal
State/Province
Kvinnherad
ZIP/Postal Code
5470
Country
Norway
Facility Name
Kvitsoy kombisenter
City
Stavanger
State/Province
Kvitsoy
ZIP/Postal Code
4180
Country
Norway
Facility Name
Luster Sjukeheimsteneste, avd. Gaupne
City
Sogndal
State/Province
Luster
ZIP/Postal Code
6868
Country
Norway
Facility Name
Samnangerheimen
City
Bergen
State/Province
Samnanger
ZIP/Postal Code
5650
Country
Norway
Facility Name
Ask bo- og omsorgssenter
City
Askoy
ZIP/Postal Code
5307
Country
Norway
Facility Name
Stiftelsen Nykirkehjemmet
City
Bergen
ZIP/Postal Code
5005
Country
Norway
Facility Name
Landaas Meninghets Eldresenter
City
Bergen
ZIP/Postal Code
5097
Country
Norway
Facility Name
Midtbygda sykehjem
City
Bergen
ZIP/Postal Code
5873
Country
Norway
Facility Name
Teiglandshagen bufellesskap
City
Bomlo
ZIP/Postal Code
5440
Country
Norway
Facility Name
Bygdaheimen
City
Eidfjord
ZIP/Postal Code
5783
Country
Norway
Facility Name
Gulen Sjukeheim
City
Gulen
ZIP/Postal Code
5966
Country
Norway
Facility Name
Laerdal Alders- og Sjukeheim
City
Laerdal
ZIP/Postal Code
6887
Country
Norway
Facility Name
Roldal pleie og omsorgstjeneste
City
Odda
ZIP/Postal Code
5760
Country
Norway
Facility Name
Byhagen Bo og Aktivitetssenter
City
Sandnes
ZIP/Postal Code
4307
Country
Norway
Facility Name
Sogndal Omsorgssenter
City
Sogndal
ZIP/Postal Code
6856
Country
Norway
Facility Name
Bergåstjern Sykehjem
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
Facility Name
Boganes Bokollektiv
City
Stavanger
ZIP/Postal Code
4032
Country
Norway
Facility Name
Oyane Sykehjem
City
Stavanger
ZIP/Postal Code
4085
Country
Norway
Facility Name
Tysnes Sjukeheim
City
Tysnes
ZIP/Postal Code
5685
Country
Norway
Facility Name
Tysvaertunet
City
Tysvaer
ZIP/Postal Code
5575
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28936121
Citation
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.
Results Reference
derived

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Continuing Education in Nursing Home Dementia Care

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