NCT01183351

Brief Summary

The increasing prevalence of dementia is a major challenge to the health authorities in most countries. Nearly all the persons suffering from dementia experience behavioural and psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes. BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal and the risk of serious adverse events is considerable. All the major treatment recommendations advise that non-pharmacological measures should be applied first when treating BPSD even though the evidence for such treatment is limited. The investigators will conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been developed in Norway and has already been implemented in a number of nursing homes in the county of Nordland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 12, 2014

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

August 13, 2010

Last Update Submit

December 11, 2014

Conditions

Dementia

Keywords

DementiaAgitationChallenging behaviourBehavioural and psychological symptoms in dementia (BPSD)

Outcome Measures

Primary Outcomes (1)

  • Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)

    8 months

Secondary Outcomes (7)

  • The Cornell scale for depression in dementia (CSDD)

    8 months

  • Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour

    8 months

  • Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)

    8 months

  • Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life

    8 months

  • Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).

    8 months

  • +2 more secondary outcomes

Study Arms (1)

Psychosocial intervention

EXPERIMENTAL

This is a single-group pilot-study

Behavioral: Psychosocial intervention

Interventions

Psychosocial interventionBEHAVIORAL

Multidisciplinary Intervention for challenging behavior in patients with Dementia (MID) is developed in clinical practice in nursing homes as an answer to the need of a systematic and simple tool for the nursing home health workers to meet agitation. The model is based on the theoretical framework of cognitive behavioural therapy (CBT) where human behaviour is understood as always acting under the influence of biological, social and psychological factors. The systematic and structured approach of CBT to problem solving is central and is transformed in the model to meet the specific characteristics of challenging behaviour in dementia.

Also known as: Multidisclinary Intervention in Dementia patients, Psychosocial intervention for challenging behavior
Psychosocial intervention

Eligibility Criteria

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

You may qualify if:

  • A permanent stay in nursing home of at least 4 weeks
  • Given verbal or written assent for participation or has written consent given on their behalf by their next of kin

You may not qualify if:

  • Lack of consent, terminal state,unremitting pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Research and Development, Innlandet Hospital Trust

Hamar, 2312, Norway

Location

MeSH Terms

Conditions

DementiaPsychomotor Agitation

Interventions

Psychosocial Intervention

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)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Geir Selbaek, MD PhD

    Sykehuset Innlandet HF

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 17, 2010

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

December 12, 2014

Record last verified: 2011-05

Locations

NO(1)