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.
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
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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)
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted29 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bergen University College
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Frode F. Jacobsen, Bergen University College
- Investigators
- Frode F Jacobsen, PhD, Study director, Bergen University College
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care
- ClinicalTrials.gov ID
- NCT01715506
- Acronym / sponsor ID
- MEDCED / 2012/304
- Keywords
- Dementia, Resident, Nursinghome, Use of restraint, Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Bergen University CollegeUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Aug 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: Educational interventionEducational 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 |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dementia
Key exclusion criteria (1 listed)
- non-dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionThe 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. | Behavioural | Educational intervention |
Primary outcome
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.
1 secondary outcome
Psychotropic drug change
Time frame: Assessment in 6-8 months, publication in approximately 18-20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Derived from this study: PubMed 28936121Jacobsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frode F Jacobsen, PhD study director
Bergen University College
24 sites in 1 country: see every site and its status.
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.