- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280890
Person- Centred Care Among Nursing Home Patients With Dementia
Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Staff training using VIPS framework
The staff will be trained to give person-centred care using the VIPS framework
|
Staff training using the VIPS framework
Other Names:
|
EXPERIMENTAL: Staff training using DCM
Staff will be supervised in how to give person-centred care using Dementia Care Mapping
|
The staff will be supervised using Dementia Care Mapping
Other Names:
|
PLACEBO_COMPARATOR: Control group
Traditional lectures using films will be given to care staff
|
Filmed traditional Lectures will be given to care staff
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
After 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychiatric Inventory (NPI-Q)
Time Frame: After 10 months
|
After 10 months
|
|
Cornell scale for depression in dementia
Time Frame: After 10 months
|
After 10 months
|
|
Quality of life in Alzheimer's Disease (QUALID)
Time Frame: After 10 months
|
After 10 months
|
|
Use of psychotropic drugs
Time Frame: After 10 months
|
collected from the patients' records
|
After 10 months
|
Clinical Dementia Rating Scale (CDR)
Time Frame: After 10 months
|
After 10 months
|
|
Lawton maintenance scale
Time Frame: After 10 months
|
Measures function in activities of daily living
|
After 10 months
|
Person-centred Care Assessment Tool (P-CAT)
Time Frame: after 10 months
|
after 10 months
|
|
QPSNordic
Time Frame: After 10 months
|
A scale developed to measure psychological and social factors in working life
|
After 10 months
|
Stress of Conscience Questionaire (SCQ)
Time Frame: After10 months
|
Assessing stressful situations experienced by staff and the degree to which they trouble the conscience
|
After10 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Knut Engedal, Dr.med, Norwegian Centre for Ageing and Health
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCCNor
- 196326/V50 (OTHER_GRANT: The Research Counsil of Norway)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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