NCT01280890

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1.1 years

First QC Date

January 18, 2011

Last Update Submit

June 11, 2012

Conditions

Keywords

DementiaNursing homePerson-centred CareStaff training

Outcome Measures

Primary Outcomes (1)

  • 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

    After 10 months

Secondary Outcomes (9)

  • Neuropsychiatric Inventory (NPI-Q)

    After 10 months

  • Cornell scale for depression in dementia

    After 10 months

  • Quality of life in Alzheimer's Disease (QUALID)

    After 10 months

  • Use of psychotropic drugs

    After 10 months

  • Clinical Dementia Rating Scale (CDR)

    After 10 months

  • +4 more secondary outcomes

Study Arms (3)

Staff training using VIPS framework

EXPERIMENTAL

The staff will be trained to give person-centred care using the VIPS framework

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

Behavioral: Staff training using DCM

Control group

PLACEBO COMPARATOR

Traditional lectures using films will be given to care staff

Behavioral: Control group

Interventions

Staff training using the VIPS framework

Also known as: Person-centred care, Dementia care
Staff training using VIPS framework

The staff will be supervised using Dementia Care Mapping

Also known as: Person-centred Care, dementia Care
Staff training using DCM
Control groupBEHAVIORAL

Filmed traditional Lectures will be given to care staff

Also known as: Staff training
Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaPsychomotor Agitation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Knut Engedal, Dr.med

    Norwegian Centre for Ageing and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 21, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

June 12, 2012

Record last verified: 2012-06