Person- Centred Care Among Nursing Home Patients With Dementia

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier:
NCT01280890
First received: January 18, 2011
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Dementia
Agitation
Behavioral: Staff training using VIPS
Behavioral: Staff training using DCM
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Person-centred Care and Dementia Care Mapping Among Nursing Home Patients - a 10 Months Randomised Controlled Intervention Study

Resource links provided by NLM:


Further study details as provided by Norwegian Centre for Ageing and Health:

Primary Outcome Measures:
  • Change in agitation at 10 months from baseline using Brief Agitation Rating Scale [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
  • Cornell scale for depression in dementia [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
  • Quality of life in Alzheimer's Disease (QUALID) [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
  • Use of psychotropic drugs [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
    collected from the patients' records

  • Clinical Dementia Rating Scale (CDR) [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
  • Lawton maintenance scale [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
    Measures function in activities of daily living

  • Person-centred Care Assessment Tool (P-CAT) [ Time Frame: after 10 months ] [ Designated as safety issue: No ]
  • QPSNordic [ Time Frame: After 10 months ] [ Designated as safety issue: No ]
    A scale developed to measure psychological and social factors in working life

  • Stress of Conscience Questionaire (SCQ) [ Time Frame: After10 months ] [ Designated as safety issue: No ]
    Assessing stressful situations experienced by staff and the degree to which they trouble the conscience


Enrollment: 624
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Staff training using VIPS framework
The staff will be trained to give person-centred care using the VIPS framework
Behavioral: Staff training using VIPS
Staff training using the VIPS framework
Other Names:
  • Person-centred care
  • Dementia care
Experimental: Staff training using DCM
Staff will be supervised in how to give person-centred care using Dementia Care Mapping
Behavioral: Staff training using DCM
The staff will be supervised using Dementia Care Mapping
Other Names:
  • Person-centred Care
  • dementia Care
Placebo Comparator: Control group
Traditional lectures using films will be given to care staff
Behavioral: Control group
Filmed traditional Lectures will be given to care staff
Other Name: Staff training

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280890

Sponsors and Collaborators
Norwegian Centre for Ageing and Health
The Research Council of Norway
Investigators
Principal Investigator: Knut Engedal, Dr.med Norwegian Centre for Ageing and Health
  More Information

No publications provided

Responsible Party: Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier: NCT01280890     History of Changes
Other Study ID Numbers: PCCNor, 196326/V50
Study First Received: January 18, 2011
Last Updated: June 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian Centre for Ageing and Health:
Dementia
Nursing home
Person-centred Care
Staff training

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014