Pain in Patients With Dementia and Behavioural Disturbances

NCT01021696 | Completed Phase 2 DMC

• 1 other identifier: 2008-007490-20
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Dementia; Pain; Agitation

Keywords

Dementia; Nursing home; Pain treatment; Pain assessment; Agitation

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory - long form (CMAI)

  CMAI has 29-item (max. score 203) to assess agitated behaviours in NH-patients. A six-point rating scale assesses the frequency with which patients manifest BPSD evaluating 29 agitated behaviours, ranging from never, less than once a week, but still occurring, once or twice a week, several times a week, once or twice a day, several times a day or several times an hour. Items are presented in four factors: I Aggressive behaviour; II Physical non-aggressive behaviour; III Verbally agitated behavior, IV hiding and hoarding. Ratings are based on face-to-face interviews with caregivers.

  CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.

Secondary Outcomes (6)

• Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)

  NPI will be used during the inclusion process, at week 2, 4, 8, and 12.

• Activity of Daily Living function (ADL)

  ADL assessment will be used during clinical investigation related to the inclusion prosess and at week 8

• Mini Mental State Examination

  Screening/clinical investigation and week 8

• Mobilisation-Observation-Behavior-Intensity-Dementia-2 (MOBID-2) Pain Scale

  Screening/clinical investigation, week 2,4,8,12

• Functional Assessment Staging (FAST)

  Screening and week 8

Study Arms (5)

Treatment as usual

NO INTERVENTION

Control group

Paracetamol

ACTIVE COMPARATOR

Intervention group

Drug: Paracetamol

Morphine

ACTIVE COMPARATOR

Intervention group, individual pain treatment

Drug: Morphine

Buprenorphine plaster

ACTIVE COMPARATOR

Intervention group, individual pain treatment

Drug: Buprenorphine plaster

Pregabalin

ACTIVE COMPARATOR

Intervention group, individual pain treatment

Drug: Pregabalin

Interventions

Paracetamol DRUG

Paracetamol Max. dose: 3g/d

Also known as: Individual pain treatment

Paracetamol

Morphine DRUG

Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d

Also known as: Individual pain treatment

Morphine

Buprenorphine plaster DRUG

5ųg/h, change each 7.day; max. dose: 10ųg/h

Also known as: Individual pain treatment

Buprenorphine plaster

Pregabalin DRUG

25mgx1/d; max 300mg/d

Also known as: individual pain treatment

Pregabalin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 at least one week history of agitation or aggression (Koss 1997).
• Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

You may not qualify if:

• Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
• Advanced severe medical disease/disorder with expected survival less than 6 months or that 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 the predominant 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 in another experimental protocol.
• Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plaster or pregabalin

Sponsors & Collaborators

• University of Bergen: lead
• The Research Council of Norway: collaborator

Study Sites (18)

Knarvik Nursing Home

Knarvik, Horadland, 5914, Norway

Location

Aastveit Nursing Home

Åstveit, Hordaland, Norway

Location

Dormkirkehjemmet

Bergen, Hordaland, 5018, Norway

Location

Fantoft Omsorgssenter

Bergen, Hordaland, 5020, Norway

Location

Bergen Red Cross Nursing Home

Bergen, Hordaland, 5035, Norway

Location

Solsletten Sykehjem

Bergen, Hordaland, 5164, Norway

Location

Mildeheimen

Bergen, Hordaland, 5259, Norway

Location

Søreide Nursing Home

Bergen, Hordaland, Norway

Location

Lindas bu- og servicecentre

Isdalstø, Hordaland, 5914, Norway

Location

Saata bu og servicecentre

Isdalstø, Hordaland, 5914, Norway

Location

Lyngbøtunet Nursing Home

Laksevåg, Hordaland, 5164, Norway

Location

Odinsvei Nursing Home

Nesttun, Hordaland, 5222, Norway

Location

Ovsttunheimen

Nesttun, Hordaland, 5223, Norway

Location

Slaathaug Nursing Home

Hafrsfjord, Rogaland, 4042, Norway

Location

Rovik Nursing Home

Sandnes, Rogaland, 4319, Norway

Location

Sola Nursing Home

Sola, Rogaland, 4097, Norway

Location

Blidensol Nursing Home

Stavanger, Rogaland, Norway

Location

Tasta Nursing Home

Stavanger, Rogaland, Norway

Location

Related Publications (10)

• Husebo BS. [Pain assessment in dementia]. Tidsskr Nor Laegeforen. 2009 Oct 8;129(19):1996-8. doi: 10.4045/tidsskr.08.0660. Norwegian.

  PMID: 19823204 BACKGROUND

• Husebo BS, Strand LI, Moe-Nilssen R, Husebo SB, Ljunggren AE. Pain behaviour and pain intensity in older persons with severe dementia: reliability of the MOBID Pain Scale by video uptake. Scand J Caring Sci. 2009 Mar;23(1):180-9. doi: 10.1111/j.1471-6712.2008.00606.x. Epub 2009 Jan 20.

  PMID: 19192240 BACKGROUND

• Husebo BS, Strand LI, Moe-Nilssen R, Borgehusebo S, Aarsland D, Ljunggren AE. Who suffers most? Dementia and pain in nursing home patients: a cross-sectional study. J Am Med Dir Assoc. 2008 Jul;9(6):427-33. doi: 10.1016/j.jamda.2008.03.001. Epub 2008 Jun 2.

  PMID: 18585645 BACKGROUND

• Husebo BS, Strand LI, Moe-Nilssen R, Husebo SB, Snow AL, Ljunggren AE. Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (MOBID): development and validation of a nurse-administered pain assessment tool for use in dementia. J Pain Symptom Manage. 2007 Jul;34(1):67-80. doi: 10.1016/j.jpainsymman.2006.10.016. Epub 2007 May 23.

  PMID: 17509814 BACKGROUND

• Griffioen C, Husebo BS, Flo E, Caljouw MAA, Achterberg WP. Opioid Prescription Use in Nursing Home Residents with Advanced Dementia. Pain Med. 2019 Jan 1;20(1):50-57. doi: 10.1093/pm/pnx268.

  PMID: 29136228 DERIVED

• Aasmul I, Husebo BS, Flo E. Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial. J Pain Symptom Manage. 2016 Dec;52(6):795-805. doi: 10.1016/j.jpainsymman.2016.07.004. Epub 2016 Aug 12.

  PMID: 27524403 DERIVED

• Habiger TF, Flo E, Achterberg WP, Husebo BS. The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial. Behav Neurol. 2016;2016:7036415. doi: 10.1155/2016/7036415. Epub 2016 May 9.

  PMID: 27247487 DERIVED

• Husebo BS, Ballard C, Fritze F, Sandvik RK, Aarsland D. Efficacy of pain treatment on mood syndrome in patients with dementia: a randomized clinical trial. Int J Geriatr Psychiatry. 2014 Aug;29(8):828-36. doi: 10.1002/gps.4063. Epub 2013 Dec 19.

  PMID: 24806873 DERIVED

• Husebo BS, Ballard C, Cohen-Mansfield J, Seifert R, Aarsland D. The response of agitated behavior to pain management in persons with dementia. Am J Geriatr Psychiatry. 2014 Jul;22(7):708-17. doi: 10.1016/j.jagp.2012.12.006. Epub 2013 Apr 20.

  PMID: 23611363 DERIVED

• Husebo BS, Ballard C, Sandvik R, Nilsen OB, Aarsland D. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ. 2011 Jul 15;343:d4065. doi: 10.1136/bmj.d4065.

  PMID: 21765198 DERIVED

MeSH Terms

Conditions

Dementia; Pain; Psychomotor Agitation; Agnosia

Interventions

Acetaminophen; Morphine; Pregabalin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Perceptual Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rolv Terje Lie, PhD

  University of Bergen, Norway

  STUDY DIRECTOR

• Bettina S. Husebo, MD, PhD

  University of Bergen, Norway

  STUDY CHAIR

• Dag Aarsland, MD, Phd

  University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

• Clive Ballard, MD, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2009
• First Posted: November 30, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 10, 2011

Record last verified: 2010-11

Locations

NO (18)