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DementiaMEDCEDNCT01715506

Continuing Education in Nursing Home Dementia Care

A study testing Educational intervention in people with Dementia and Agitation, run by Bergen University College at 24 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Dementia, Agitation
What is being tested?
Educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
24 sitesNorway
Study dates
Aug 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Dementia

Who cannot join

  • non-dementia

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Norway24 sites
  • Solas bo- og rehabiliteringssenter

    Ålgård, Gjesdal, 4330

  • Ask bo- og omsorgssenter

    Askoy, 5307

  • Samnangerheimen

    Bergen, Samnanger, 5650

  • Stiftelsen Nykirkehjemmet

    Bergen, 5005

  • Landaas Meninghets Eldresenter

    Bergen, 5097

  • Midtbygda sykehjem

    Bergen, 5873

  • Teiglandshagen bufellesskap

    Bømlo, 5440

  • Bygdaheimen

    Eidfjord, 5783

  • Flora Omsorgssenter

    Florø, Flora, 6900

  • Furuhaugane Omsorgssenter

    Florø, Flora, 6900

  • Gulen Sjukeheim

    Gulen, 5966

  • Laerdal Alders- og Sjukeheim

    Lærdal, 6887

  • Roldal pleie og omsorgstjeneste

    Odda, 5760

  • Husnestunet

    Rosendal, Kvinnherad, 5470

  • Rosendalstunet

    Rosendal, Kvinnherad, 5470

  • Byhagen Bo og Aktivitetssenter

    Sandnes, 4307

  • Luster Sjukeheimsteneste, avd. Gaupne

    Sogndal, Luster, 6868

  • Sogndal Omsorgssenter

    Sogndal, 6856

  • Kvitsoy kombisenter

    Stavanger, Kvitsoy, 4180

  • Bergåstjern Sykehjem

    Stavanger, 4016

  • Boganes Bokollektiv

    Stavanger, 4032

  • Oyane Sykehjem

    Stavanger, 4085

  • Tysnes Sjukeheim

    Tysnes, 5685

  • Tysvaertunet

    Tysvær, 5575

Other trials in Norway

About this study

Official title: Modeling and Evaluating Evidence Based 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.

Read the 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)

Conditions
Dementia, Agitation
Being tested
Educational intervention
Keywords
Dementia, Resident, Nursinghome, Use of restraint, Agitation
Medical subject headings
Dementia, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational interventionBehavioural

    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.

Study groups in NCT01715506
Study groupRoleWhat they receive
Educational interventionExperimentalEducational 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
Receives: Behavioral: Educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2014
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715506
Sponsor's protocol ID
2012/304
Acronym
MEDCED
Status last verified
Jul 2016
First submitted
25 Oct 2012
Last updated
25 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28936121

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention in people with Dementia and Agitation, run by Bergen University College at 24 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Restraint change (time frame: Assessment in 6-8 months, publication in approximately 18-20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01715506, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.

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