Person- Centred Care Among Nursing Home Patients With Dementia
Primary Purpose
Dementia, Agitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Staff training using VIPS
Staff training using DCM
Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Nursing home, Person-centred Care, Staff training
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Result from the inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Staff training using VIPS framework
Staff training using DCM
Control group
Arm Description
The staff will be trained to give person-centred care using the VIPS framework
Staff will be supervised in how to give person-centred care using Dementia Care Mapping
Traditional lectures using films will be given to care staff
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Neuropsychiatric Inventory (NPI-Q)
Cornell scale for depression in dementia
Quality of life in Alzheimer's Disease (QUALID)
Use of psychotropic drugs
collected from the patients' records
Clinical Dementia Rating Scale (CDR)
Lawton maintenance scale
Measures function in activities of daily living
Person-centred Care Assessment Tool (P-CAT)
QPSNordic
A scale developed to measure psychological and social factors in working life
Stress of Conscience Questionaire (SCQ)
Assessing stressful situations experienced by staff and the degree to which they trouble the conscience
Full Information
NCT ID
NCT01280890
First Posted
January 18, 2011
Last Updated
June 11, 2012
Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT01280890
Brief Title
Person- Centred Care Among Nursing Home Patients With Dementia
Official Title
Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Agitation
Keywords
Dementia, Nursing home, Person-centred Care, Staff training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
624 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staff training using VIPS framework
Arm Type
Experimental
Arm Description
The staff will be trained to give person-centred care using the VIPS framework
Arm Title
Staff training using DCM
Arm Type
Experimental
Arm Description
Staff will be supervised in how to give person-centred care using Dementia Care Mapping
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Traditional lectures using films will be given to care staff
Intervention Type
Behavioral
Intervention Name(s)
Staff training using VIPS
Other Intervention Name(s)
Person-centred care, Dementia care
Intervention Description
Staff training using the VIPS framework
Intervention Type
Behavioral
Intervention Name(s)
Staff training using DCM
Other Intervention Name(s)
Person-centred Care, dementia Care
Intervention Description
The staff will be supervised using Dementia Care Mapping
Intervention Type
Behavioral
Intervention Name(s)
Control group
Other Intervention Name(s)
Staff training
Intervention Description
Filmed traditional Lectures will be given to care staff
Primary Outcome Measure Information:
Title
Change in agitation at 10 months from baseline using Brief Agitation Rating Scale
Description
Brief Agitation Rating Scale (BARS)will be used to measure change in agitation from basline to end of intervention after 10 months
Time Frame
After 10 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI-Q)
Time Frame
After 10 months
Title
Cornell scale for depression in dementia
Time Frame
After 10 months
Title
Quality of life in Alzheimer's Disease (QUALID)
Time Frame
After 10 months
Title
Use of psychotropic drugs
Description
collected from the patients' records
Time Frame
After 10 months
Title
Clinical Dementia Rating Scale (CDR)
Time Frame
After 10 months
Title
Lawton maintenance scale
Description
Measures function in activities of daily living
Time Frame
After 10 months
Title
Person-centred Care Assessment Tool (P-CAT)
Time Frame
after 10 months
Title
QPSNordic
Description
A scale developed to measure psychological and social factors in working life
Time Frame
After 10 months
Title
Stress of Conscience Questionaire (SCQ)
Description
Assessing stressful situations experienced by staff and the degree to which they trouble the conscience
Time Frame
After10 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Result from the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Engedal, Dr.med
Organizational Affiliation
Norwegian Centre for Ageing and Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Person- Centred Care Among Nursing Home Patients With Dementia
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