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DementiaPhase 2/3NCT01021696

Pain in Patients With Dementia and Behavioural Disturbances

A Phase 2/3 study testing Paracetamol, Morphine and Buprenorphine plaster in people with Dementia and Pain, run by University of Bergen at 18 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Pain, Agitation
What is being tested?
Paracetamol, Morphine and Buprenorphine plaster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
18 sitesNorway
Study dates
Nov 2009to Oct 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Norway18 sites

  • Aastveit Nursing Home

    Åstveit, Hordaland

  • Dormkirkehjemmet

    Bergen, Hordaland, 5018

  • Fantoft Omsorgssenter

    Bergen, Hordaland, 5020

  • Bergen Red Cross Nursing Home

    Bergen, Hordaland, 5035

  • Solsletten Sykehjem

    Bergen, Hordaland, 5164

  • Mildeheimen

    Bergen, Hordaland, 5259

  • Søreide Nursing Home

    Bergen, Hordaland

  • Slaathaug Nursing Home

    Hafrsfjord, Rogaland, 4042

  • Lindas bu- og servicecentre

    Isdalstø, Hordaland, 5914

  • Saata bu og servicecentre

    Isdalstø, Hordaland, 5914

  • Knarvik Nursing Home

    Knarvik, Horadland, 5914

  • Lyngbøtunet Nursing Home

    Laksevåg, Hordaland, 5164

  • Odinsvei Nursing Home

    Nesttun, Hordaland, 5222

  • Ovsttunheimen

    Nesttun, Hordaland, 5223

  • Rovik Nursing Home

    Sandnes, Rogaland, 4319

  • Sola Nursing Home

    Sola, Rogaland, 4097

  • Blidensol Nursing Home

    Stavanger, Rogaland

  • Tasta Nursing Home

    Stavanger, Rogaland

Other trials in Norway

About this study

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

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
Read the 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
Being tested
Paracetamol, Morphine, Buprenorphine plaster, Pregabalin
Keywords
Dementia, Nursing home, Pain treatment, Pain assessment, Agitation
Medical subject headings
Dementia, Pain, Psychomotor Agitation, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParacetamolDrug

    Also called Individual pain treatment

    Paracetamol Max. dose: 3g/d

  • MorphineDrug

    Also called Individual pain treatment

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

  • Buprenorphine plasterDrug

    Also called Individual pain treatment

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

  • PregabalinDrug

    Also called individual pain treatment

    25mgx1/d; max 300mg/d

Study groups in NCT01021696
Study groupRoleWhat they receive
Treatment as usualNo interventionControl group
ParacetamolActive comparatorIntervention group
Receives: Drug: Paracetamol
MorphineActive comparatorIntervention group, individual pain treatment
Receives: Drug: Morphine
Buprenorphine plasterActive comparatorIntervention group, individual pain treatment
Receives: Drug: Buprenorphine plaster
PregabalinActive comparatorIntervention group, individual pain treatment
Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: Screening/clinical investigation and week 8

  4. 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.

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

  5. 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).

    Measured: Screening and week 8

  6. 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).

    Measured: week 2,4,8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01021696
Sponsor's protocol ID
2008-007490-20
Other IDs
2008
Status last verified
Nov 2010
First submitted
27 Nov 2009
Last updated
10 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

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

    PubMed 19823204

  • 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.

    PubMed 19192240

  • 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.

    PubMed 18585645

  • 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.

    PubMed 17509814

  • 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.

    PubMed 29136228

  • 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.

    PubMed 27524403

  • 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.

    PubMed 27247487

  • 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.

    PubMed 24806873

  • 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.

    PubMed 23611363

  • 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.

    PubMed 21765198

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paracetamol, Morphine and Buprenorphine plaster in people with Dementia and Pain, run by University of Bergen at 18 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohen-Mansfield Agitation Inventory - long form (CMAI) (time frame: CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021696, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.

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