Pain in Patients With Dementia and Behavioural Disturbances

NCT ID: NCT01021696

Last Updated: 2011-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-10-31

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

Detailed 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.

Conditions

Dementia; Pain; Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment as usual

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Paracetamol

Intervention group

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

Paracetamol Max. dose: 3g/d

Morphine

Intervention group, individual pain treatment

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Buprenorphine plaster

Intervention group, individual pain treatment

Group Type: ACTIVE_COMPARATOR

Buprenorphine plaster

Intervention Type: DRUG

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

Pregabalin

Intervention group, individual pain treatment

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

25mgx1/d; max 300mg/d

Interventions

Paracetamol

Paracetamol Max. dose: 3g/d

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Buprenorphine plaster

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

Intervention Type: DRUG

Pregabalin

25mgx1/d; max 300mg/d

Intervention Type: DRUG

Other Intervention Names

Individual pain treatment; Individual pain treatment; Individual pain treatment; individual pain treatment

Eligibility Criteria

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 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Department of Public Health and Primary Health Care, University of Bergen

Principal Investigators

Rolv Terje Lie, PhD

Role: STUDY_DIRECTOR

University of Bergen, Norway

Bettina S. Husebo, MD, PhD

Role: STUDY_CHAIR

University of Bergen, Norway

Dag Aarsland, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Norway

Clive Ballard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Knarvik Nursing Home

Knarvik, Horadland, Norway

Aastveit Nursing Home

Åstveit, Hordaland, Norway

Dormkirkehjemmet

Bergen, Hordaland, Norway

Fantoft Omsorgssenter

Bergen, Hordaland, Norway

Bergen Red Cross Nursing Home

Bergen, Hordaland, Norway

Solsletten Sykehjem

Bergen, Hordaland, Norway

Mildeheimen

Bergen, Hordaland, Norway

Søreide Nursing Home

Bergen, Hordaland, Norway

Lindas bu- og servicecentre

Isdalstø, Hordaland, Norway

Saata bu og servicecentre

Isdalstø, Hordaland, Norway

Lyngbøtunet Nursing Home

Laksevåg, Hordaland, Norway

Odinsvei Nursing Home

Nesttun, Hordaland, Norway

Ovsttunheimen

Nesttun, Hordaland, Norway

Slaathaug Nursing Home

Hafrsfjord, Rogaland, Norway

Rovik Nursing Home

Sandnes, Rogaland, Norway

Sola Nursing Home

Sola, Rogaland, Norway

Blidensol Nursing Home

Stavanger, Rogaland, Norway

Tasta Nursing Home

Stavanger, Rogaland, Norway

Countries

Norway

References

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

Reference Type: BACKGROUND

PMID: 19823204 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19192240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18585645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17509814 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29136228 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27524403 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27247487 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24806873 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23611363 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21765198 (View on PubMed)

Other Identifiers

2008-007490-20

Identifier Type: -

Identifier Source: org_study_id