Abstract
Keywords
INTRODUCTION
Dementia has received considerable interest over the last decade. At the present time, there are no curative treatments that can alter or prevent the pathophysiology of dementia, thus it is necessary to explore interventions that may delay the progressive functional decline [1]. To face the expected demographic burden of dementia and its impact on health care systems, many Western countries have implemented national strategies. In France, a global and massive effort targeted the optimization of dementia care by offering gradual personalized approaches to cover patients’ and families’ needs at home [2]. Indeed, several innovative health care services have been implemented nationwide, notably services offering occupational therapy (OT). OT permits tailored home support in terms of rehabilitation for subjects with mild-to-moderate dementia; it aims to restore or mobilize the remaining capacities of individuals and adapt their domestic environment so that they may improve and maintain social and relational life. A growing interest in OT currently exists [3–5] and several trials are ongoing [6–8]. In France, OT especially targets early dementia stages. A recent review has concluded that the literature provides a “proof of concept” that dementia related functional decline may be delayed via OT interventions [9]. However, even if OT has shown to be effective in some trials’ context, it does not mean that implementation in routine care brings similar benefits. Indeed, trials include convenience samples of dementia patients whereas the general dementia population is highly heterogeneous in terms of socio-demographic and clinical characteristics. Moreover, routine care practices can differ from the conceptual frame in clinical trials. The clinical efficacy of OT has been demonstrated in the Netherlands [10–12], but the intervention’s replication in another national context failed to demonstrate any effectiveness with dementia patients [13]. Thus, there is a need to investigate OT’s effects under real-world conditions. We conducted an observational study based on routine care practice in order to systematically investigate the clinical evolution of patients benefiting from OT with pre- and post-clinical assessments. In this study, we aimed to document the benefits of OT on patients’ cognitive, functional, and behavioral aspects as well as on patient’s quality of life, caregivers’ burden, and informal care. Secondly, we aimed to identify the factors that affect the likelihood that a patient will benefit from the intervention.
METHODS
Subjects
The study took place in Aquitaine, a region in the South West of France, where 28 settings offering occupational therapy have been implemented. All were contacted in order to propose the study project and 16 accepted. All patients referred to these settings were systematically assessed over an inclusion period of 6 months from January 2014 to June 2014. No exclusion criteria were applied because we wanted to cover the whole scope of patients benefiting from OT. It means that some patients could have be included and followed even if they had no primary caregiver or only a professional caregiver. Box 1 describes the recommendations that should be followed by general practitioners or specialists to refer diagnosed dementia patients to OT.
Referral’s recommendations for occupational therapy
Indications:
Community dwelling
Patient with Alzheimer’s disease or other type of dementia
Early stage of the disease (ideally MMSE > 18, potentially MMSE > 15)
Restriction in daily functioning
Accept principles for occupational therapy intervention
Lack of indication:
No restriction in daily functioning
Advanced stage of the disease, no communication, no possibility to train remaining abilities
Caregiver compensate the patient daily functioning difficulties and has no demand for specific intervention
Patient refusing any home intervention
The study was approved by the research committee of the Regional Health Agency and all patients and potential caregivers were informed and gave informed consent for their data to become part of a database for future research.
Occupational therapy
Patients are referred to occupational therapy under medical prescription and followed a standardized treatment procedure consisting of 12 to 15 home sessions performed by therapist over a period of 3 months focusing on patients and potential primary caregivers. The initial assessment (1 or 2 sessions) allows the therapist to evaluate remaining abilities, and to define patients’ and caregivers’ expectations and needs. In the following sessions, patients were taught to optimize these compensatory and environmental strategies to improve their performance in daily activities. Primary caregivers were trained to use effective supervision, problem solving, and coping strategies to sustain patients’ social participation. At the end, a few sessions are devoted to initiate and prepare the home care support following the OT intervention.
Clinical outcomes
A neuropsychological screening battery was administered by the occupational therapist to all patients and caregivers at baseline, 3 months, and 6 months. This means that the 3-month assessment occurred at the end of the 12 to 15 sessions and the 6-month assessment occurred after a 3-month wash-out period without OT. The battery included the Mini-Mental State Examination (MMSE) to evaluate global cognitive function [14], the Disability Assessment in Dementia (DAD) scale to evaluate functional status [15, 16], the Neuropsychiatric Inventory (NPI) to assess neuropsychiatric symptoms [17], the Zarit scale to evaluate caregivers’ burden [18], the Visual Analogue Scale in the EQ-5D to evaluate patient’s quality of life [19], and the amount of informal care (in hours) provided by caregivers in the last month through the Resource Utilization in Dementia’s scale [20]. We considered only the care provided by caregivers in basic and instrumental activities of daily living; supervision time was not considered.
Statistical analysis
Trajectories of the outcomes were modeled according to time since initiation of OT using a linear mixed model [21]. Time was considered in three categories (baseline, 3 months, and 6 months), with the 3-month visit being considered as the reference time for comparison. Indeed, the primary purpose of the project was to investigate the potential benefits of OT over the intervention period as well as the short-term benefits after the intervention. Within-subject correlation was taken into account through correlated errors with an unstructured covariance matrix. Due to ceiling and floor effects and curvilinearity (unequal interval scaling) for MMSE, NPI scores, and amount of informal care, we used a previously published procedure that corrects the metrological properties to normalize the score distributions [22]. We adjusted all analyses for age, gender, and level of education. Sensitivity analyses were performed excluding patients who refused at least one follow-up assessment over the 6-month period.
We also studied which patients’ characteristics were associated with better improvement in two clinical outcomes: patients’ function and caregivers’ burden. Therefore, patients were classified into the following two groups: the “responders group” who experienced a decline above the median of the DAD (or Zarit score) change between baseline and 3 months and the “non-responders group”, who had a decline below the median. We adopted a pragmatic approach by studying only demographic and clinical variables that were easy to assess by therapists: all characteristics listed in Table 1, with the exception of caregivers’ characteristics, were considered (patients’ age, sex, education level, living situation, level of incomes, dementia etiology, time since diagnosis, use of drug, and MMSE). Responders and non-responders were compared with logistic regressions using a stepwise descending selection procedure. Significance level was set at p < 0.05. All analyses were carried out using SAS software, version 9.3 (SAS Institute Inc).
RESULTS
Study population
Four hundred and twenty-seven patients were referred to occupational therapists over the study period and 6 patients refused the intervention after the initial assessment sessions, leaving 421 for the current analyses. Table 1 describes the main sample characteristics. The mean age of participants was 82.2 (SD = 7.2). With regards to their educational level, 25% reported a primary level, 34.4% a secondary level, and 40.6% a high school or university level. Most patients had Alzheimer’s disease (61.9%). One hundred and fifty-two patients (38%) had a recent diagnosis of dementia (less than one year), 76 (19%) had a diagnosis made between 1 and 2 years before, and 172 (43%) reported a time since diagnosis more than 2 years. Referral recommendations concerning MMSE score that should be >15, were respected for only 65% of the sample: 25.3% had a MMSE between 10 and 15 and 7.1% had a MMSE below 10.Figure 1 describes the flowchart of included patients. Among the 421 patients, 382 (90.7%) were evaluated at the 3-month follow-up and 317 (75.3%) at the 6-month follow-up. Not surprisingly, the main reason for attrition was institutionalization (7% at 6-month follow-up). Respectively, less than 2% and 4% of the participants refused to be assessed at the 3-month and 6-month follow-ups. Other reasons for attrition comprised patients’ death, difficulties to contact caregivers, or patients’ hospitalizations.
Patients’ outcomes
Means and standard errors (SE) of the cognitive, functional, psychiatric, and patients’ quality of life measures at baseline, 3 and 6 month follow-ups, as well as p-values gained from linear mixed model analyses are reported in Table 2. With regard to cognitive performances, the mixed model analysis did not demonstrate a significant time effect. The MMSE mean score was 17.3 at baseline and remained stable over time. With regard to functional performances, the mixed model analysis showed a statistically significant time effect with a stabilization phase between baseline and the 3-month follow-up and a significant worsening between 3 and 6 months (crude worsening of 2.9 points, p < 0.0001). Concerning neuropsychiatric troubles, we found a significant reduction in NPI scores between baseline and the 3-month follow-up (crude reduction of 3.3 points, p < 0.0001), followed with a non-significant reduction (–1.3 points, p = 0.47). Lastly, quality of life was improved at the 3-month follow-up in a non-significant trend (crude improvement of 1.1 points, p = 0.16) followed with a significant worsening between the 3- and 6-month follow-ups (crude reduction of 2.6 points, p = 0.02).
Caregivers’ outcomes
Means and standard errors (SE) of caregivers’ burden and amount of informal care at baseline, 3 months, and 6 months as well as p-values gained from linear mixed model analyses are reported in Table 3. The studied sample consisted of non-professional caregivers who were interviewed both at baseline and at the 3- and 6-month follow-ups. The score on the Burden Zarit scale rated by caregivers at 3 months was significantly reduced compared to baseline (crude reduction of 1.8 points, p = 0.03), whereas the score remained stable after 3 months (p = 0.47). With regard to informal care, the linear mixed model analysis also demonstrated a significant reduction in amount of time over the 3 months of intervention (crude reduction of total hours = 9 hours, p = 0.003) whereas the amount of informal care slightly increased between the 3- and 6-month follow-ups (p = 0.65).
Sensitivity analyses
After exclusion of all participants who refused at least one follow-up assessment, all the results were similar to those from the initial analyses.
Characteristics of the responders
Three hundred and twenty-seven patients had data on DAD scores at the 3-month follow-up and 301 had data on the Zarit scale score allowing for the investigation of responders’ characteristics for each of these outcomes (Table 4). According to functional performances, the variables significantly associated with responder’s status based on DAD decline were educational level and cognitive performances: dementia patients with high school or university level were more frequently non-responders than those with lower educational levels (OR = 0.39, 95% CI 0.22–0.71) and patients with advanced stage of dementia (10≤MMSE≤15) benefited less from OT than those with mild dementia (MMSE≥21) (OR = 0.37, 95% CI 0.20–0.69). According to caregivers’ burden, the variables significantly associated with responder’s status were patient’s gender and time since diagnosis: caregivers of female patients were more frequently responders (OR = 1.94, 95% CI 1.13–3.34) as well as patients with more recent diagnosis compared with those who had a 1 to 2 years old diagnosis (OR = 0.40, 95% CI 0.20–0.79).
DISCUSSION
In this prospective observational study, our findings suggest that occupational therapy could benefit dementia patients and caregivers on several clinical outcomes including neuropsychiatric symptoms and functional performances. A significant worsening of function was found between 3 and 6 months, after the 3-month stabilization phase corresponding to the intervention period; psychiatric symptoms were reduced over the intervention period and remained steady over the 3 following months. Moreover, patients’ quality of life assessed by caregivers slightly increased over the intervention period and was significantly reduced thereafter. Additionally, these potential clinical benefits also correspond to caregivers’ well-being with reduction in subjective burden and in provision of informal care over the intervention period.
Providing community-based programs that aim to improve the quality of life for people with dementia and their carers, and training and supporting carers are key aspects of French policy. In this perspective, several evidence-based interventions have been implemented through the national Alzheimer plan 2008–2012 [2]; even if high-quality, well-controlled intervention studies are essential to test effective strategies for people with dementia, translation under routine practice and real-world conditions is particularly challenging for such vulnerable individuals [23].Although such strategies would deserve to be tested on a systematic basis, we did not find any study assessing the efficacy of OT under routine care conditions. Our study represents a first step toward closing this gap in the literature. Managing neuropsychiatric behaviors is one of the most challenging aspects of caring for individuals with dementia. Thus our findings may be of importance because families’ difficulties to cope with behavioral troubles are important risks factors for poor prognosis [24]. Consensus reports recommended nonpharmacological approaches as the initial treatment modality for neuropsychiatric symptoms [25, 26]. Nevertheless, routine management of behavioral troubles firstly involve pharmacologic treatments that have modest to no benefits [27–29]. A multifaceted program with OT as the core of the intervention and focusing on behavioral symptoms management reported significant benefits on patient’s behavior and caregiver’s burden [30]. OT also improved communication with patients. Because OT focuses on tailored activities providing pleasure and social stimulation, the intervention may afford control over self-identity, a critical attribute of selfhood that may endure throughout the disease process [30, 31]. Moreover, occupational therapists contribute to train caregivers’ supervision skills and self-abilities to interact with patients which can in turn improve patients’ well-being and reduce their behavioral troubles. Important clinical implications can be derived from these findings. Indeed, there is a growing attention toward early stage of dementia because it could represent a relevant temporal window for therapeutic strategies and facilitate later home support acceptance. Dementia care has been described as suboptimal even at early stages [32, 33]. Indeed, recent findings have suggested that lack of specific medical follow-up after diagnosis could explain poor prognosis of dementia patients who have been early diagnosed [34, 35]. Because the process of the loss of skills in performing complex activities (e.g., the independent activities of daily living) starts much earlier than the loss of skills in performing self-care activities, opportunities to improve skills in performing daily activities remain and early home tailored support should be promoted at diagnosis [36].
Our study also demonstrated that despite established recommendations, the sample was heterogeneous in terms of type of dementia as well as cognitive performances. One third of patients referred to OT had low cognitive performances under the threshold of 15 with the MMSE; the latter could less frequently benefit from OT than those with mild dementia with regards to functional decline. Since its implementation in France, OT has appeared as highly solicited new services with up to 6 months waiting list. Thus, our findings could also contribute to foster clinicians to follow the recommendations in order to prioritize patients and optimize OT benefits in a population perspective. Mild dementia stages should be foremost concerned.
This research has some limitations, primarily because of its observational design. In order to assess the efficacy of OT under routine care conditions and after its nationwide implementation, a control group would have been advisable but for ethical reason, being in a waiting-list (without any OT over the study period) could not be proposed to dementia patients referred to occupational therapists. Others limitations are that all patients were not subjected to the same intervention duration and that initiation of specific pharmacological treatment, particularly neuroleptics (not assessed in our study) between follow-ups could have impacted on patients’ clinical course. As this study was based on an observational routine care design, some patients may not have a diagnosis based on recommended dementia criteria; however, they were considered by their physicians both as demented and as requiring home support, meaning that they have a real functional repercussion of their cognitive problems. Moreover, more than 90% of the included patients had received a diagnosis performed by a specialist, either in a memory consultation or in liberal activity, who are used to applying dementia criteria in their practice.
Furthermore, although mixed design with external assessments should be privileged for such observational studies, patients and caregivers were not assessed by blind assessors. Nevertheless, the ecological context of our study is also a strength of our findings because trusting relationships between therapists and patients/caregivers allowed a very low attrition rate due to refusal. Other strengths of our study include the important sample size and the representativeness of dementia patients referred to OT; a recent study on dementia patients at a national level reported the same distribution of demographic characteristics and cognitive performances as in our study sample [37]. Lastly, lack of exclusion criteria allowed us to include isolated individuals (those without a primary caregiver) who are classically excluded in clinical trials [6, 38].
CONCLUSION
The short-term gains in clinically relevant outcomes obtained with OT for both patients and their caregivers underline the importance of adequate and timely diagnosis with proactive dementia management. Future studies should explore more in detail which sub-groups of patients could gain more benefits from OT as well as its long-term clinical effects, notably on global care quality and users’ satisfaction. Moreover, as OT has been designed as a short-term intervention, consequences of its disruption should be studied in more detail [39].
Footnotes
ACKNOWLEDGMENTS
The authors acknowledge all the therapists and ESA (French acronym for Equipe Spécialisée Alzheimer) staff for their collaboration in data collection and management.
The current project was conducted under a partnership agreement between the Institut National de la Santé et de la Recherche Médicale (INSERM), the University of Bordeaux, and the Regional Health Agency (ARS d’Aquitaine). The project received a financial support from France Alzheimer’sassociation.
