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Completed

NCT Number: NCT01715506

Continuing Education in Nursing Home Dementia Care

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.

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Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flora Omsorgssenter, Florø, Flora, Norway

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dementia

Exclusion criteria

  • non-dementia

Treatment and study plan

Educational intervention

Behavioral

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 outcomes

  1. Restraint change

    Time frame: Assessment in 6-8 months, publication in approximately 18-20 months

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

Secondary outcomes

  1. Psychotropic drug change

    Time frame: Assessment in 6-8 months, publication in approximately 18-20 months

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

Sponsors and collaborators

Lead sponsor

Bergen University College

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care

Acronym: MEDCED

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 29, 2012
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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