Pain in Patients With Dementia and Behavioural Disturbances

Pain Clinical Trial

Official title:

The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021696
• Other study ID #: 2008-007490-20
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 27, 2009
• Last updated: August 9, 2011
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Ethics CommitteeNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agitation
• Dementia
• Pain

Intervention

Drug:
• Paracetamol
Paracetamol Max. dose: 3g/d
• Morphine
Morphine ret. Tab. 5mgx2/d; max. dose:10mgx2/d
• Buprenorphine plaster
5ug/h, change each 7.day; max. dose: 10ug/h
• Pregabalin
25mgx1/d; max 300mg/d

Locations

Country	Name	City	State
Norway	Aastveit Nursing Home	Aastveit	Hordaland
Norway	Bergen Red Cross Nursing Home	Bergen	Hordaland
Norway	Dormkirkehjemmet	Bergen	Hordaland
Norway	Fantoft Omsorgssenter	Bergen	Hordaland
Norway	Mildeheimen	Bergen	Hordaland
Norway	Solsletten Sykehjem	Bergen	Hordaland
Norway	Søreide Nursing Home	Bergen	Hordaland
Norway	Slaathaug Nursing Home	Hafrsfjord	Rogaland
Norway	Lindas bu- og servicecentre	Isdalsto	Hordaland
Norway	Saata bu og servicecentre	Isdalsto	Hordaland
Norway	Knarvik Nursing Home	Knarvik	Horadland
Norway	Lyngbøtunet Nursing Home	Laksevag	Hordaland
Norway	Odinsvei Nursing Home	Nesttun	Hordaland
Norway	Ovsttunheimen	Nesttun	Hordaland
Norway	Rovik Nursing Home	Sandnes	Rogaland
Norway	Sola Nursing Home	Sola	Rogaland
Norway	Blidensol Nursing Home	Stavanger	Rogaland
Norway	Tasta Nursing Home	Stavanger	Rogaland

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Epub 2007 May 23. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)	NPI is a caregiver based interview (10 min.), assessing 10 BPSD and 2 neurovegetative areas with total score and subscales for: delusion, hallucination, agitation, depression, anxiety, disinhibition apathy, irritability, aberrant motor activity, sleep, appetite. Frequency, severity, and caregiver's distress are measured. The NH-version will be used, recently validated in Norwegian (AGS Panel 1998). A higher score reflects increased frequency and severity of the disturbances.	NPI will be used during the inclusion process, at week 2, 4, 8, and 12.	No
Secondary	Activity of Daily Living function (ADL)	ADL assess physical function. Rating includes activities like feeding, moving, personal toilet, and dressing higher values indicating higher levels of activities of daily functioning and independency (Sheikh 1979). The scale includes 10 items (0-20 score). The ADL score is derived from caregiver interview. Administration of the ADL takes approximately 5 minutes.	ADL assessment will be used during clinical investigation related to the inclusion prosess and at week 8	No
Secondary	Mini Mental State Examination	The MMSE is a 30-point mental status examination scale that enables cut-off differentiation for levels of severity of cognitive impairment (Folstein 1975). Cut point for moderate dementia: <20. The question consist of several orientation question (10 points), registration and recall task (6), attention task (5), three stage command (3), two naming task (2), repetition task (1), reading comprehension task (1), written sentence (1), and a visual construction (1). The test takes 15 minutes to administer and the patient is asked the questions directly by the examiner.	Screening/clinical investigation and week 8	No
Secondary	Mobilisation-Observation-Behavior-Intensity-Dementia-2 (MOBID-2) Pain Scale	MOBID-2 Pain Scale is a staff-administered behavioural instrument for assessment pain in older persons with dementia (Husebo 2008a). 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. Administration of the MOBID-2 takes approximately 5 minutes.	Screening/clinical investigation, week 2,4,8,12	No
Secondary	Functional Assessment Staging (FAST)	FAST describes a continuum of seven stages and sub stages from normality to most severe dementia (Hughes 1982). Moderate to severe dementia is consistent with Fast stage of 5 or 6 or 7. Stage 5 is defined as moderately severe cognitive decline, with deficient performance in activities of daily living such as choosing proper clothing and maintaining hygiene. Stage 6 is defined as severe cognitive decline with incontinence and decreased ability to clothe, bathe, toilet oneself, severely limited speech, vocabulary, emotional expression. FAST score is derived from caregiver interview (5 min).	Screening and week 8	No
Secondary	Adverse events (AE) and serious adverse event (SAE)	Safety and tolerability assessments will consist of monitoring and recording all adverse events (AE) and serious adverse events (SAE) and the regular monitoring of vital signs (BP, puls); AE and SAE registration and report is related to each patient, each medication each centre with reportation to the Norwegian Medicines Agency (study code EUDRACTNR. 2008-007490-20).	week 2,4,8	Yes