Pain in Patients With Dementia and Behavioural Disturbances

Last updated: August 9, 2011
Sponsor: University of Bergen
Overall Status: Completed

Phase

2/3

Condition

Dementia

Pain

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT01021696
2008-007490-20
  • Ages > 65
  • All Genders

Study Summary

In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

  • pain increase BPSD in patients with dementia

  • individual pain treatment decrease BPSD in patients with dementia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 65 and older

  • Residing in the NHs for at least 4 weeks

  • Dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association 1994), FAST score > 4 (Hughes 1982).

  • Clinically relevant BPSD, operationally defined as CMAI score ≥ 39 or higher or/and atleast one week history of agitation or aggression (Koss 1997).

  • Written, informed consent provided by the participant (if they have capacity) orassent (if they do not have capacity) and a written proxy informed consent from alegally authorized representative empowered to make health-related decisions for thepotential study participant.

Exclusion

Exclusion Criteria:

  • Clinician responsible for care, or study clinician considers that the patient suffersfrom any physical condition, which would make participation in the trial distressingor likely to increase suffering

  • Advanced severe medical disease/disorder with expected survival less than 6 months orthat could interfere with participation

  • Psychosis or other severe mental disorder prior to dementia diagnosis;

  • Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as thepredominant symptom

  • Schizophrenia, schizoaffective disorder and bipolar disorder

  • Uncontrolled epilepsy

  • Severe liver impairment

  • Renal failure, as measured by or equivalent to an estimated creatinine clearance of < 50mL/min/1.73m,

  • Severe injury or anaemia (Hb < 8.5 mmol/l), comatose state, current enrolment inanother experimental protocol.

  • Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plasteror pregabalin

Study Design

Total Participants: 352
Study Start date:
November 01, 2009
Estimated Completion Date:
October 31, 2010

Study Description

We intend to conduct an eight weeks, multi-centre, rater-blinded, cluster randomized, and parallel-group trial, with follow up after four weeks. We will choose cluster randomizing by practical reasons. 920 NH patients were screened and 352 patients with moderate or severe dementia and BPSD were included. The treatment period is 8 weeks, with further follow after four weeks.

The primary outcome measure will be reduction in aggression and agitation as well as other items which are measured by means of CMAI (Cohen Mansfield Agitation Inventory). Secondary outcome are reduction in NPI-NH-subscale agitation/aggression and other items which are measured by the Neuropsychiatric Inventory, Nursing Home Version (NPI-NH). Further, we want to evaluate the concomitant use of acute medication. Additionally, Activities of Daily Living function (ADL) and MIni Mental State Examination (MMSE) will be used as secondary outcome measure.

Pain in patients with dementia will be assessed and followed by the MOBID-2 Pain Scale (secondary outcome measure). MOBID-2 Pain Scale is a staff-administered behavioural instrument for assessment pain in older persons with dementia with god validity and reliability (Husebo 2008, 2009). MOBID-2 is based on patient's pain behaviour in connection with standardised, guided movements of different body part, and pain behaviour related to internal organs, head and skin. Additionally, pain will be registered by pain diagnoses, -etiology, and -duration. The MOBID-2 score is derived from caregiver in a clinical bedside situation during morning care.

Adverse events will be recorded and evaluated throughout the study as the primary assessment of safety and tolerability.

Inclusion criteria: Patients of either gender, 60 years of age or older, living in a nursing home (NH) diagnosed moderate or severe dementia measured by the Functional Assessment Staging (FAST) and MMSE, and BPSD in form of agitation / aggression as measured by subscale of NPI-NH and CMAI.

Exclusion criteria: Patients without cognitive impairment and without BPSD. Patients with hepatic or renal failure or diseases that make it impossible to follow the study schedule.

Connect with a study center

  • Knarvik Nursing Home

    Knarvik, Horadland 5914
    Norway

    Site Not Available

  • Aastveit Nursing Home

    Aastveit, Hordaland
    Norway

    Site Not Available

  • Bergen Red Cross Nursing Home

    Bergen, Hordaland 5035
    Norway

    Site Not Available

  • Dormkirkehjemmet

    Bergen, Hordaland 5018
    Norway

    Site Not Available

  • Fantoft Omsorgssenter

    Bergen, Hordaland 5020
    Norway

    Site Not Available

  • Mildeheimen

    Bergen, Hordaland 5259
    Norway

    Site Not Available

  • Solsletten Sykehjem

    Bergen, Hordaland 5164
    Norway

    Site Not Available

  • Søreide Nursing Home

    Bergen, Hordaland
    Norway

    Site Not Available

  • Lindas bu- og servicecentre

    Isdalsto, Hordaland 5914
    Norway

    Site Not Available

  • Saata bu og servicecentre

    Isdalsto, Hordaland 5914
    Norway

    Site Not Available

  • Lyngbøtunet Nursing Home

    Laksevag, Hordaland 5164
    Norway

    Site Not Available

  • Odinsvei Nursing Home

    Nesttun, Hordaland 5222
    Norway

    Site Not Available

  • Ovsttunheimen

    Nesttun, Hordaland 5223
    Norway

    Site Not Available

  • Slaathaug Nursing Home

    Hafrsfjord, Rogaland 4042
    Norway

    Site Not Available

  • Rovik Nursing Home

    Sandnes, Rogaland 4319
    Norway

    Site Not Available

  • Sola Nursing Home

    Sola, Rogaland 4097
    Norway

    Site Not Available

  • Blidensol Nursing Home

    Stavanger, Rogaland
    Norway

    Site Not Available

  • Tasta Nursing Home

    Stavanger, Rogaland
    Norway

    Site Not Available

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