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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01021696
Other study ID # 2008-007490-20
Secondary ID
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:

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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


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

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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
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