DementiaNCT01280890
Person- Centred Care Among Nursing Home Patients With Dementia
A study testing Staff training using VIPS and Staff training using DCM in people with Dementia and Agitation, run by Norwegian Centre for Ageing and Health.
Trial summary
Dementia is a common and devastating disease in the elderly. No cure exist and there is an increasing need for care. To improve knowledge on how to provide better care for the patients with dementia in nursing homes, the investigators will carry out a controlled trial using two forms of education and developmental… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Staff training using VIPS and Staff training using DCM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 624 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with dementia living in nursing homes
- A score of 1,2 or 3 on the Clinical Dementia Rating Scale (CDR)
- The nursing staff in the wards where the patients are
Who cannot join
- Result from the inclusion criteria
About this study
Official title: Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study
Dementia is a common and devastating disease in the elderly. No cure exist and there is an increasing need for care. To improve knowledge on how to provide better care for the patients with dementia in nursing homes, the investigators will carry out a controlled trial using two forms of education and developmental interventions towards the nursing home care staff: a structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in a 10 months randomised controlled study. In accordance with the knowledge found in the literature the investigators hypothesize that both VIPS framework and DCM will be more effective than a traditional educational program about dementia provided to the staff in nursing homes. The positive effects will be seen as reduced agitation in patients, less use of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also have a better effect on staffs' well-being than traditional education in dementia. The aim of the study is to confirm or reject these hypotheses.
Read the detailed description
This is a controlled intervention trial with three groups of staff recruited from 15 nursing homes in the city of Oslo. The intervention will be carried out over 10 months. Randomization will be done at institutional level. Before randomization all patients in the participating nursing homes should be screened for dementia. This will be done by interviewing the registered nurses in the nursing homes using the Clinical dementia rating scale (CDR), Neuropsychiatric inventory (NPI-Q), Cornell scale for depression in dementia (CSDD). In addition information from the records will be used. Diagnosis of dementia will be made according to ICD-10 criteria, using a diagnostic algorithm that is evaluated in an ongoing nursing home study.
The nursing homes will be randomized in tree groups. Group A - Applying the VIPS- framework to develop Person Centred Care (PCC) and milieu therapy. The staff will be introduced to the model for applying the VIPS-framework to promote PCC in the daily care. A manual including films with information and examples will be distributed to all staff. Two auxiliary nurses are appointed as resource persons (RP) from each ward and one registered nurse (RN) from each nursing home will be trained as coach. The RPs and the leading registered nurse (RN) will plan and lead weekly consensus meetings with the staff in the ward using the VIPS-framework in discussions of concrete care situations. The researches will receive monthly written standard reports on attendance and contents of the consensus meetings from the RPs and can be contacted for support when necessary.
Group B - using Dementia Care Mapping (DCM) developing Person Centred Care and milieu therapy All staff and leaders in the nursing home will be introduced to the DCM- process in a presentation of the method and person centred care as a value base for DCM. A group of 3-5 staff members from each nursing home will be trained as DCM basic users. Dementia Care Mappings (4-6 hours) will be made in each unit in the nursing homes and feed-back (1, 5 hours) will be given to the staff within a week after the mapping. Based on the findings and the reflections in the feed-back session, action plans on how to develop care to selected patients and/or to the group of patients, will be created in the units. The project leader will be responsible for the introduction, mapping and feed-back sessions and give the necessary supervision to create action plans. The leaders and staff in the nursing home units will be responsible for the implementation of the changes to develop practice.The DCM-process will be repeated after 6-8 months
Group C (control group) - traditional education Lectures made as 5 DVD films lasting for 30 minutes, will be given to the nursing home staff on three themes: types of dementia, legal aspects of use of restraints and challenging behavior
The staff in group A and B will receive the same lectures as the staff in the control group.
Effect will be measured on patient and staff level, and measurements will be done at baseline and after 10 months of intervention. Data will be collected by research assistants, who will not take part in the three different intervention programs and not be employed by the nursing homes that are included in the study.
- Being tested
- Staff training using VIPS, Staff training using DCM, Control group
- Keywords
- Dementia, Nursing home, Person-centred Care, Staff training
- 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.
Staff training using VIPSBehavioural
Also called Person-centred care, Dementia care
Staff training using the VIPS framework
Staff training using DCMBehavioural
Also called Person-centred Care, dementia Care
The staff will be supervised using Dementia Care Mapping
Control groupBehavioural
Also called Staff training
Filmed traditional Lectures will be given to care staff
| Study group | Role | What they receive |
|---|---|---|
| Staff training using VIPS framework | Experimental | The staff will be trained to give person-centred care using the VIPS framework Receives: Behavioral: Staff training using VIPS |
| Staff training using DCM | Experimental | Staff will be supervised in how to give person-centred care using Dementia Care Mapping Receives: Behavioral: Staff training using DCM |
| Control group | Placebo comparator | Traditional lectures using films will be given to care staff Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in agitation at 10 months from baseline using Brief Agitation Rating Scale
Brief Agitation Rating Scale (BARS)will be used to measure change in agitation from basline to end of intervention after 10 months
Measured: After 10 months
Secondary outcomes (9)
Neuropsychiatric Inventory (NPI-Q)
Measured: After 10 months
Cornell scale for depression in dementia
Measured: After 10 months
Quality of life in Alzheimer's Disease (QUALID)
Measured: After 10 months
Use of psychotropic drugs
collected from the patients' records
Measured: After 10 months
Clinical Dementia Rating Scale (CDR)
Measured: After 10 months
Lawton maintenance scale
Measures function in activities of daily living
Measured: After 10 months
Person-centred Care Assessment Tool (P-CAT)
Measured: after 10 months
QPSNordic
A scale developed to measure psychological and social factors in working life
Measured: After 10 months
Stress of Conscience Questionaire (SCQ)
Assessing stressful situations experienced by staff and the degree to which they trouble the conscience
Measured: After10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Knut Engedal, Dr.med, Principal investigator, Norwegian Centre for Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280890
- Sponsor's protocol ID
- PCCNor
- Other IDs
- 196326/V50
- Status last verified
- Jun 2012
- First submitted
- 18 Jan 2011
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT01280890
- Acronym / sponsor ID
- PCCNor
- Keywords
- Dementia, Nursing home, Person-centred Care, Staff training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Jan 2011 (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.
Dementia is a common and devastating disease in the elderly. No cure exist and there is an increasing need for care. To improve knowledge on how to provide better care for the patients with dementia in nursing homes, the investigators will carry out a controlled trial using two forms of education and developmental interventions towards the nursing home care staff: a structured framework (VIPS) and dementia care mapping (DCM)to develop person-centred care in a 10 months randomised controlled study. In accordance with the knowledge found in the literature the investigators hypothesize that both VIPS framework and DCM will be more effective than a traditional educational program about dementia provided to the staff in nursing homes. The positive effects will be seen as reduced agitation in patients, less use of psychotropic drugs and improved quality of life. Using VIPS framework and DCM will also have a better effect on staffs' well-being than traditional education in dementia. The aim of the study is to confirm or reject these hypotheses.
Detailed description
This is a controlled intervention trial with three groups of staff recruited from 15 nursing homes in the city of Oslo. The intervention will be carried out over 10 months. Randomization will be done at institutional level. Before randomization all patients in the participating nursing homes should be screened for dementia. This will be done by interviewing the registered nurses in the nursing homes using the Clinical dementia rating scale (CDR), Neuropsychiatric inventory (NPI-Q), Cornell scale for depression in dementia (CSDD). In addition information from the records will be used. Diagnosis of dementia will be made according to ICD-10 criteria, using a diagnostic algorithm that is evaluated in an ongoing nursing home study.
The nursing homes will be randomized in tree groups. Group A - Applying the VIPS- framework to develop Person Centred Care (PCC) and milieu therapy. The staff will be introduced to the model for applying the VIPS-framework to promote PCC in the daily care. A manual including films with information and examples will be distributed to all staff. Two auxiliary nurses are appointed as resource persons (RP) from each ward and one registered nurse (RN) from each nursing home will be trained as coach. The RPs and the leading registered nurse (RN) will plan and lead weekly consensus meetings with the staff in the ward using the VIPS-framework in discussions of concrete care situations. The researches will receive monthly written standard reports on attendance and contents of the consensus meetings from the RPs and can be contacted for support when necessary.
Group B - using Dementia Care Mapping (DCM) developing Person Centred Care and milieu therapy All staff and leaders in the nursing home will be introduced to the DCM- process in a presentation of the method and person centred care as a value base for DCM. A group of 3-5 staff members from each nursing home will be trained as DCM basic users. Dementia Care Mappings (4-6 hours) will be made in each unit in the nursing homes and feed-back (1, 5 hours) will be given to the staff within a week after the mapping. Based on the findings and the reflections in the feed-back session, action plans on how to develop care to selected patients and/or to the group of patients, will be created in the units. The project leader will be responsible for the introduction, mapping and feed-back sessions and give the necessary supervision to create action plans. The leaders and staff in the nursing home units will be responsible for the implementation of the changes to develop practice.The DCM-process will be repeated after 6-8 months
Group C (control group) - traditional education Lectures made as 5 DVD films lasting for 30 minutes, will be given to the nursing home staff on three themes: types of dementia, legal aspects of use of restraints and challenging behavior
The staff in group A and B will receive the same lectures as the staff in the control group.
Effect will be measured on patient and staff level, and measurements will be done at baseline and after 10 months of intervention. Data will be collected by research assistants, who will not take part in the three different intervention programs and not be employed by the nursing homes that are included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staff training using VIPS framework | Experimental | Behavioral: Staff training using VIPSThe staff will be trained to give person-centred care using the VIPS framework |
| Staff training using DCM | Experimental | Behavioral: Staff training using DCMStaff will be supervised in how to give person-centred care using Dementia Care Mapping |
| Control group | Placebo comparator | Behavioral: Control groupTraditional lectures using films will be given to care staff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Persons with dementia living in nursing homes
- A score of 1,2 or 3 on the Clinical Dementia Rating Scale (CDR)
- The nursing staff in the wards where the patients are
Key exclusion criteria (1 listed)
- Result from the inclusion criteria
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 |
|---|---|---|
| Staff training using VIPSAlso: Person-centred care, Dementia careStaff training using the VIPS framework | Behavioural | Staff training using VIPS framework |
| Staff training using DCMAlso: Person-centred Care, dementia CareThe staff will be supervised using Dementia Care Mapping | Behavioural | Staff training using DCM |
| Control groupAlso: Staff trainingFilmed traditional Lectures will be given to care staff | Behavioural | Control group |
Primary outcome
Change in agitation at 10 months from baseline using Brief Agitation Rating Scale
Time frame: After 10 months
Brief Agitation Rating Scale (BARS)will be used to measure change in agitation from basline to end of intervention after 10 months
9 secondary outcomes
Neuropsychiatric Inventory (NPI-Q)
Time frame: After 10 months
Cornell scale for depression in dementia
Time frame: After 10 months
Quality of life in Alzheimer's Disease (QUALID)
Time frame: After 10 months
Use of psychotropic drugs
Time frame: After 10 months
Clinical Dementia Rating Scale (CDR)
Time frame: After 10 months
Lawton maintenance scale
Time frame: After 10 months
Person-centred Care Assessment Tool (P-CAT)
Time frame: after 10 months
QPSNordic
Time frame: After 10 months
Stress of Conscience Questionaire (SCQ)
Time frame: After10 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 12 Jun 2012.
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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.
Knut Engedal, Dr.med principal investigator
Norwegian Centre for Ageing and Health
Questions about this trial
What is this clinical trial studying?
A study testing Staff training using VIPS and Staff training using DCM in people with Dementia and Agitation, run by Norwegian Centre for Ageing and Health.
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 3 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 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in agitation at 10 months from baseline using Brief Agitation Rating Scale (time frame: After 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2012.