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The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

ABSTRACT: Background. Neuropsychiatric symptoms are common in people with dementia, and pain is thought to be an important underlying factor. Pain has previously been associated with agitation, and pain treatment has been shown to ameliorate agitated behaviour. So far, the association between pain and psychosis and the effect of pain treatment on psychotic symptoms is unclear. Furthermore, the impact of opioid treatment on psychosis is not established. Aim. To investigate the efficacy of a stepwise protocol for treating pain (SPTP) on psychosis and agitation measured with the Neuropsychiatric Inventory, Nursing Home version, and to explore the impact of opioid analgesics on psychosis. Method. Secondary analyses are from a cluster-randomised controlled trial including 352 patients with advanced dementia and agitation from 18 nursing homes in Western Norway. The intervention group received pain treatment according to SPTP. Results. Pain was associated with disinhibition (adjusted OR: 1.21, 95% CI: 1.10-1.34) and irritability (adjusted OR: 1.10, 95% CI: 1.01-1.21) at baseline. Pain treatment reduced agitation (p < 0.001, df = 1; 300) and aberrant motor behaviour (p = 0.017, df = 1; 300). Psychosis was reduced in people with at least one symptom at baseline (p = 0.034, df = 1; 135). The use of opioid analgesics did not increase psychotic symptoms. Study Registration. This trial is registered with ClinicalTrials.gov (NCT01021696), Norwegian Medicines Agency, EudraCT (EudraCTnr: 2008-007490-20).

SUBMITTER: Habiger TF

PROVIDER: S-EPMC4876223 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

Habiger Torstein F TF Flo Elisabeth E Achterberg Wilco P WP Husebo Bettina S BS

Behavioural neurology 20160509

Background. Neuropsychiatric symptoms are common in people with dementia, and pain is thought to be an important underlying factor. Pain has previously been associated with agitation, and pain treatment has been shown to ameliorate agitated behaviour. So far, the association between pain and psychosis and the effect of pain treatment on psychotic symptoms is unclear. Furthermore, the impact of opioid treatment on psychosis is not established. Aim. To investigate the efficacy of a stepwise protoc ...[more]

PMID: 27247487

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Project description:BackgroundMany people with dementia (PwD) live and die with undiagnosed and untreated pain and are no longer able to report their suffering. Several pain assessment tools have been developed, tested, and implemented in clinical practice, but nursing home patients are reported to be still in pain. Clinicians and research groups worldwide are seeking novel approaches to encode the prediction, prevalence, and associations to pain in PwD.ParticipantsThe data in this analysis are acquired from the COSMOS study, a cluster-randomized controlled trial (2014 to 2015), aimed to improve the quality of life in nursing home patients (N = 723) through the implementation of a multicomponent intervention. We utilize baseline data of PwD (N = 219) with complete datasets of pain and agitation.MethodSystems analysis explores the relationship between pain and agitation using the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Pain Scale, Cohen-Mansfield Agitation Inventory (CMAI), and Neuropsychiatric Inventory-Nursing Home version (NPI-NH). For each patient, the individualized continuous time trajectory, and rates of change of pain and agitation are estimated. We determine the relationship between these rates by analyzing them across the entire group.ResultsWe found that the new analysis method can generate individualized estimations for pain and agitation evolution for PwD, as well as their relationship. For 189 of 219 PwD, results show that whenever pain increases or decreases, agitation does too, with the same rate. The method also identifies PwD for whom pain or agitation remains constant while the other varies over time, and patients for whom agitation and pain do not change together. The algorithm is scalable to other variables and compatible with wearable devices and digital sensors.ConclusionWe presented a new approach to clinical data analysis using systems concepts and algorithms. We found that it is possible to quantify and visualize relationships between variables with a precision only dependent on the precision of measurements. This method should be further validated, but incipient results show great potential, especially for wearable-generated continuous data.

Project description:BackgroundAgitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL). There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost.Methods and findingsThis was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU) in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review), followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy). Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI]), neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH]), antipsychotic use, global deterioration (Clinical Dementia Rating), mood (Cornell Scale for Depression in Dementia), unmet needs (Camberwell Assessment of Need for the Elderly), mortality, quality of interactions (Quality of Interactions Scale [QUIS]), pain (Abbey Pain Scale), and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0.24). There were also statistically significant benefits in agitation (CMAI Z score 2.68, p = 0.0076; mean difference 4.27, SEM 1.59; 95% CI -7.39, -1.15; Cohen's D 0.23) and overall neuropsychiatric symptoms (NPI-NH Z score 3.52, p < 0.001; mean difference 4.55, SEM 1.28; 95% CI -7.07,-2.02; Cohen's D 0.30). Benefits were greatest in people with moderately severe dementia. There was a statistically significant benefit in positive care interactions as measured by QUIS (19.7% increase, SEM 8.94; 95% CI 2.12, 37.16, p = 0.03; Cohen's D 0.55). There were no statistically significant differences between WHELD and TAU for the other outcomes. A sensitivity analysis using a pre-specified imputation model confirmed statistically significant benefits in DEMQOL-Proxy, CMAI, and NPI-NH outcomes with the WHELD intervention. Antipsychotic drug use was at a low stable level in both treatment groups, and the intervention did not reduce use. The WHELD intervention reduced cost compared to TAU, and the benefits achieved were therefore associated with a cost saving. The main limitation was that antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. An additional limitation was the inherent challenge of assessing QoL in this patient group.ConclusionsThese findings suggest that the WHELD intervention confers benefits in terms of QoL, agitation, and neuropsychiatric symptoms, albeit with relatively small effect sizes, as well as cost saving in a model that can readily be implemented in nursing homes. Future work should consider how to facilitate sustainability of the intervention in this setting.Trial registrationISRCTN Registry ISRCTN62237498.

Project description:BACKGROUND:Agitation in Alzheimer's disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD. METHODS AND FINDINGS:We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI). Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI), Clinical Global Impression Change (CGI-C), Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p?=?0.26); or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p?=?0.012) and 12 (-9.6; -15.0 to -4.3 p?=?0.0005). Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD. CONCLUSIONS:Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms. TRIAL REGISTRATION:ClinicalTrials.gov NCT00371059. TRIAL REGISTRATION:International Standard Randomised Controlled Trial 24953404.

Project description:BackgroundClinical guidelines recommend non-pharmacological interventions as the first line of treatment for agitation in dementia. One intervention that shows some promise as a treatment for agitation is essential oils. The objective of this study was to provide preliminary evidence of the effectiveness and feasibility of using topically-administered, individualized essential oil preparations for the alleviation of agitation in persons with dementia.MethodsWe conducted a 10-week pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial to compare the effectiveness of topically-administered, individualized essential oil preparations to control (placebo) preparations. Outcomes included frequency and severity of agitation, quality of life, frequency of antipsychotic medication use and physical restraint, incidence of adverse events, and trial feasibility. Participants with dementia and clinically significant agitation were recruited from five residential aged-care facilities across regional South Australia.ResultsThirty-eight participants were randomized from five sites. Accounting for random effects, we found statistically significant differences between the intervention and control groups in Pittsburgh Agitation Scale (PAS) aberrant vocalization sub score, Cohen Mansfield Agitation Inventory (CMAI) verbally agitated sub score and CMAI total score at week 4, but not at weeks 8 (post-intervention) or 10 (follow-up). No significant time-group interactions were observed for other PAS/CMAI scores or sub scores, quality of life - Alzheimer's disease total score, or frequency of physical restraint or as-needed antipsychotic medication. No adverse events were reported in any group.ConclusionsThe study findings highlight some promising effects of topically-administered, individualized essential oil preparations for agitation in dementia, and indicate that a large multi-center, cluster-randomized controlled trial of this treatment is feasible.Trial registrationAustralian New Zealand Clinical Trial Registry [ACTRN12617001159347].

Project description:BackgroundSerious games (SGs) are used as complementary approaches to stimulate patients with dementia. However, many of the SGs use out-of-the-shelf technologies that may not always be suitable for such populations, as they can lead to negative behaviors, such as anxiety, fatigue, and even cybersickness.ObjectiveThis study aims to evaluate how patients with dementia interact and accept 5 out-of-the-shelf technologies while completing 10 virtual reality tasks.MethodsA total of 12 participants diagnosed with dementia (mean age 75.08 [SD 8.07] years, mean Mini-Mental State Examination score 17.33 [SD 5.79], and mean schooling 5.55 [SD 3.30]) at a health care center in Portugal were invited to participate in this study. A within-subject experimental design was used to allow all participants to interact with all technologies, such as HTC VIVE, head-mounted display (HMD), tablet, mouse, augmented reality (AR), leap motion (LM), and a combination of HMD with LM. Participants' performance was quantified through behavioral and verbal responses, which were captured through video recordings and written notes.ResultsThe findings of this study revealed that the user experience using technology was dependent on the patient profile; the patients had a better user experience when they use technologies with direct interaction configuration as opposed to indirect interaction configuration in terms of assistance required (P=.01) and comprehension (P=.01); the participants did not trigger any emotional responses when using any of the technologies; the participants' performance was task-dependent; the most cost-effective technology was the mouse, whereas the least cost-effective was AR; and all the technologies, except for one (HMD with LM), were not exposed to external hazards.ConclusionsMost participants were able to perform tasks using out-of-the-shelf technologies. However, there is no perfect technology, as they are not explicitly designed to address the needs and skills of people with dementia. Here, we propose a set of guidelines that aim to help health professionals and engineers maximize user experience when using such technologies for the population with dementia.

Dataset Information

The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

Publications

The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

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