The Doll Therapy as a First Line Treatment for Behavioral and Psychologic Symptoms of Dementia in Nursing Homes Residents: A Randomized, Controlled Study

doi:10.21203/rs.3.rs-534727/v1

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The Doll Therapy as a First Line Treatment for Behavioral and Psychologic Symptoms of Dementia in Nursing Homes Residents: A Randomized, Controlled Study

https://doi.org/10.21203/rs.3.rs-534727/v1

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Background. Patients affected by dementia are severely affected by the development of behavioral and psychologic symptoms (BPSD) which represent a burden for patients and caregivers. The use of psychotropic drugs in the control of BPSD is widely diffused, however the use of a first line non-pharmacologic approach is highly recommended.

Here we evaluate the effect of doll therapy (DT) in the management of BPSD, on the reduction of caregiver burden and delirium incidence in nursing home residents by a randomized controlled trial.

Methods. We enrolled fifty-two nursing homes residents living with dementia and BPSD. Subjects were randomized to DT (26) or standard treatment (ST, 26), we measured BPSD, caregiver burden and delirium with standard clinical scales at baseline, after 45 and 90 days.

In order to evaluate the presence of BPSD we used Neuropsychiatric Inventory (NPI) scale and the A.Di.CO scale, the caregiver burden was measured by the Greutzner scale and delirium by the Confusion Assessment Method (CAM) scale.

Results. DT was more effective in reducing agitation and aggressiveness as respect to ST. Moreover DT globally reduced the presence of BPSD as dysphoria, wandering and apathy. We observed a significant reduction of the professional caregiver burden and the incidence of delirium was significantly reduced in subjects treated with DT.

Conclusions. We show that DT is more effective that ST in the control of BSPD in patients affected by moderate to severe dementia. Moreover we suggest that DT may effective in reducing the incidence of delirium.

Trial Registration: Retrospectively registered in ClinicalTrials.gov the 02^nd June 2, 2021 trial registration number NCT04920591

Geriatrics & Gerontology

dementia

behavioral and psychologic symptoms of dementia

nursing home

doll therapy

delirium

non-pharmacological approach

During the clinical course of dementia, the appearance of behavioural and psychologic symptoms (BPSD) [1–3] severely worsen the burden due to the disease. More than 80% of patients living with dementia will experience the development of BPSD, which often will be cause of institutionalization. BPSD includes agitation, elation, wandering, depression, delusions and hallucinations [4, 5], these symptoms are difficult to manage with standard pharmacologic approach and represent a serious problem both for families and for professional caregivers in nursing homes [6, 7]. The presence of BPSD often leads to the use of multiple psychotropic drugs, as a consequence patients are exposed to severe adverse events with scarce therapeutic effect [4, 8]. Psychotropic drugs increases mortality [9] and reduces patients’ physical [10, 11] and cognitive performances [12]. De-prescribing has been proposed in order to reduce severe adverse events within a multicomponent intervention showing improved health outcomes in elderly patients affected by cognitive impairment and BPSD [13]. Together with de-prescribing, several guidelines recommend the use of non-pharmacologic interventions as first line treatment for BPSD [14–16].

Amongst non-pharmacologic intervention, doll therapy (DT) has been proposed as an useful tool to reduce BPSD in patients affected by moderate to severe dementia, mostly in nursing homes [17]. Previous studies suggested that DT is useful in reducing agitation, psychotropic drug administration and in increasing patients’ quality of life [17–19]. However, despite some interesting results, published studies are mainly cohort, case-control and observational or exploratory studies [17, 20, 21]

Although the mechanism of action of DT is not fully explained, the attachment theory [21–23] has been evoked in order to explain its efficacy in the control of BPSD [21, 24]. Attachment behaviour is the tendency of every person to seek for protection and physical closeness when feeling vulnerable, this tendency persist during the whole life [25], and is particularly important in patients affected by dementia. During the course of the disease, patients becomes more vulnerable and some of the BPSD as wandering, dysphoria, anxiety, agitation and even aggressiveness might be interpreted as attachment requests. In this condition the doll, perceived as a translational object [19, 21, 24], catalyze patients’ attention and, hence, reduce the attachment requests [26]. The observation of patients affected by dementia interacting with the doll shows that they treat the doll as a real baby needing care and hence they might replace their attachment request with caregiving behaviours. Frequently patients interact with the doll taking care of her needs, reassuring and lulling the doll. Following this theory we postulated that DT may also reduce the incidence of delirium catalyzing patients’ attention.

Despite the theoretic premises and some interesting experimental data, we are in need of controlled clinical trials to support the clinical efficacy of DT in the control of BPSD, in the reduction of caregiver burden and in the reduction of delirium.

The present study evaluate, with a randomized controlled approach, the efficacy of DT as respect to standard clinical approach in the management of BPSD, in the reduction of caregiver burden and in the reduction of delirium in patients affected by moderate to severe dementia living in nursing homes.

Study design.

This is a randomized controlled trial with two parallel arms, here we assess the effect of DT compared with Standard clinical Treatment (ST) on BPSD and on the caregiver burden in persons with dementia residents in two Italian nursing homes. The Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-pharmacologic treatments has been applied [27].

Ethical considerations and Consent to Participate.

The Ethical Committee “Comitato Etico Interaziendale AO Città della Salute e della Scienza di Torino” approved the study (Ref. no. CE il 04/10/2018 protocol number 0098548). Written informed consent was obtained from all the participants.

Participants.

Patients residents in two Italian nursing homes (“Casa di Riposo Borsetti Sella Facenda in Mosso Biella (BI) and the “Residenza per anziani Don Giuseppe Eandi” in Lagnagsco (CN)) were enrolled in the study between the 1 January 2019 and 31 October 2019 according with the following inclusion/exclusion criteria.

Inclusion criteria: age ≥65 years; diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2; presence of agitation and/or aggressiveness; manual and visual abilities sufficient to interact with the doll.

Exclusion criteria: age <65 years; patients refuse to participate; mild forms of dementia (CDR<2); contraindication for DT; life expectancy lower than 3 months; negative interaction with the doll.

The experience of mournful events related to parental experience is considered a contraindication to the DT [28].

Patients were randomly assigned to DT or ST, the randomization was carried on computer-generated tables by the principal investigator; the patients received a consecutive number after enrolment and were subsequently allocated to randomization list, as described by Kim and Shin [29].

Intervention.

The doll used in the study is the “empathy doll” (Fig.1), nurses responsible for doll administration received detailed information on the aim of using DT and on the study procedure. The intervention has been fully described in our previous study [30]. The investigators informed professional and family caregivers on the mean and efficacy of DT in patients affected by dementia and BPSD, the caregiver were allowed to ask questions and received detailed answers, the concern about possible infantilization of the patients has been clearly addressed and discussed. At the end of the discussion an informative brochure on BPSD in dementia and on the role of DT was given to the caregivers, as described in our previous study [30].

The patients’ interaction with the doll was evaluated with standard methods using the Engagement Observation Rating Tool for Doll Therapy, this tool has been described in details in [31, 32]. Patients’ interaction with doll was observed for 7 days prior to randomization and rated on the first and the last day of the week. Patients with positive attitude (towards the doll were included in the study and randomized to DT or standard treatment (ST). Patients with negative interaction (refuse the doll, become agitated and or aggressive) or neutral attitude (ignore the doll) were excluded from the study.

In DT group the doll were administered two times a day for two hours in the morning, two

hours in the afternoon and in case of BPSD. The administration of DT was the first choice in case of BPSD; if BPSD persist, the use of pharmacologic treatment was allowed and noted. The patient can freely interact with the doll and if he/she refuses the doll, the caregiver would not insist, this type of intervention has been described in [30].

In the control group, the caring physician freely chose the kind of pharmacological intervention, according with standard clinical care (ST). DT and controls were comparable for antipsychotic baseline treatment (Table 1).

Outcomes.

Primary outcomes were the reduction of BPSD and the reduction of professional caregiver burden

Secondary outcome was the reduction of delirium.

Analyzed variables.

Presence of BPSD was evaluated with the Neuropsychiatric Inventory (NPI) scale [33] and with the A.Di.CO scale to specifically evaluate agitation and aggressiveness [30]. The A.Di.Co scale is a scale derived from the DISCO scale [34, 35], it evaluates the presence of BPSD using 10 items dived in clusters, the presence of moderate to severe agitation is scored 2.

The NPI scale was administered in a semi-structured interview setting with a close professional caregiver according with standard clinical practice described in [36]. The use of NPI allow us to evaluate the presence of several BPSD and to rate their frequency and severity. NPI evaluates different BPSD as described in [36, 37] and namely delusions, apathy, hallucinations, disinhibition, agitation/aggression, irritability, depression/dysphoria, aberrant motor behaviour, anxiety, night time behaviour disturbances, euphoria, and appetite and eating abnormalities. Each item receive a score on a 4-point scale for the frequency (0=never, 1=less than once a week, 2= at least once a week, 3=more than one a week, but less than once a day, 4=every day). The severity of the symptom is evaluated on a 3-point scale ranging from 1 to 3 (1=mild, 2=moderate, 3=severe (requires pharmacologic treatment). The distress of the caregiver regarding the behaviour is evaluated by a score ranging from 0 to 5 (0= no stress, 1= minimal, 2 = Mild, 3= Moderate, 4= Severe, 5= very severe). The NPI total score ranges from 0 to 144 [36].

In order to specifically evaluate the professional caregiver burden the Gruetzner scale [38] was used, the presence of delirium was evaluated by the use of the Confusion Assessment Method (CAM) scale [39]. Cognition and functional status were evaluated by the Short Portable Mental Questionnaire (SPMQ) [40], the Activity of Daily Living (ADL) scale and the Instrumental Activity of Daily Living (IADL) score [41] respectively.

Age and gender were also recorded. Data collection and analyses were blinded as respect to patients’ treatment.

Variables of interest were collected at baseline, after 45 and 90 days of intervention (Fig. 2).

Statistical analyses.

As no previous study measured the efficacy of DT in using A.Di.CO and NPI, in the period of the study drawing, the power analysis was conducted using an estimated large effect size (f = 0.40), an alpha level of 0.05, and a power of 0.8. A sample size of 52 is necessary (26 each group) for primary outcomes [42].

All the analyzed variables were tested for normality by the kurtosis test and they were all normally distributed. Patients randomized to DT were compared to patients randomized to ST by one-way ANOVA for continuous variables and by χ2 test for gender. The effect of DT was evaluated per protocol using the two-way ANOVA for repeated measurements.

SPSS 25.0 were used for the statistical analyses and p<0.05 was considered statistically significant. Graphs were drawn using GraphPad 8.0 for Windows.

Sixty-one residents in nursing homes were eligible to the study, of those 52 were recruited. Three residents refused to participate whereas six (9.6%) have a neutral or negative interaction with the doll, general characteristics of patients included in the study versus patients excluded were similar (data not shown).

The DT group did not significantly differ for patients in ST group for age, gender, cognitive performance, level of independence, presence of delirium, presence of BPSD; the only variable that significantly differs in the two groups was the professional caregiver burden measured by the Greutzner scale, which was significantly higher in DT group (Table 2).

There were no dropouts during the study and the DT was well accepted during the whole study by patients and caregivers.

DT is effective in reducing BPSD and caregiver burden.

DT was more effective in reducing agitation and aggressiveness as respect to ST, in particular we observed a significant reduction in the A.Di.Co score (Fig.3 A) and in the items of NPI rating agitation (Fig. 3C). Moreover DT globally reduced the presence of BPSD as shown by the reduction of NPI global score (Fig.3B), in particular we observed a significant amelioration of dysphoria (Fig.3D), wandering (Fig.3F) and apathy (Fig.3E).

Thanks to the amelioration of BPSD, we observed a significant reduction of the professional caregiver burden (Fig. 4A).

DT is effective in reducing incidence of delirium.

As secondary outcome, we measured the incidence of delirium with the CAM scale; our hypothesis was that the doll, as transitional object, might catalyze patients’ attention and reduce the risk of delirium. Interestingly in the subjects treated with DT, incidence of delirium was significantly reduced (Fig 4B).

The use of doll treatment may be useful as a non-pharmacologic approach to control BPSD in patients with moderate to advanced forms of dementia [43]. Despite some evidences on the efficacy of this approach [44], its use is still not widespread because of some ethical concerns and lack of solid scientific evidences. Amongst the ethical concerns feelings of infantilizing the patient [45] and difficulties in finding the target patient for the treatment [46] have been raised.

In our study, after adequate information, no family nor professional caregiver rise objection and refuses the use of DT. We proposed the use of DT only after a careful observation of patients interaction with the doll, this observation allow us to exclude from the study patients that have a neutral or negative interaction with the doll, thus maximizing the possible positive effects of the treatment and avoiding discomfort for the patients. We observed the interaction of the subjects with the doll for seven days, during this period, only six subjects have a neutral or negative interaction, and none of them becomes aggressive and agitated after DT administration, they simply refuse the doll. We did not find significant differences between residents refusing and accepting the doll, hence we recommend proposing the doll and observing the patients reaction in order to choose the best candidates for the DT.

The lack of solid scientific evidences is mainly due to the difficult in standardization of non-pharmacologic intervention; as regards DT some attempt towards standardization have been done with well-designed randomized controlled clinical trials [20, 47–49]. The randomized-controlled clinical trials agree on the efficacy of DT in ameliorating BPSD in nursing home residents. In particular Ylmaz & Asiret shown a reduction in the agitation and others BPSD and an increase in the patients’ cognitive performance [49]. Here we show that DT was even more effective than ST in reducing agitation and aggressiveness. In our recent work on an acute care geriatric unit we observed the same effect over a shorter period [30].

Beside the effect on agitation and aggressiveness, we observed a reduction of dysphoria and wandering and an amelioration of apathy. The reduction of apathy and dysphoria observed in our study confirms the results of previous non randomized-controlled studies suggesting that DT may stimulate patients’ perception [28], ameliorating their communication abilities, their self-esteem and overall quality of life [50, 51].

Thanks to the effects on BPSD, DT was able to significantly reduce the perceived professional caregiver burden; reducing the caregiver burden will contribute to higher quality of care for persons living with dementia [52], hence it is one of the main goals of treating BPSD.

Delirium is common amongst older patients and the risk of developing delirium in increased by the presence of cognitive impairment [53, 54]. The prevention of delirium is of paramount importance, ameliorate patients clinical outcome and comfort [55, 56]. Non-pharmacologic approaches have been suggested for the prevention of delirium [55] and, although sparse, data currently available suggest efficacy for some tools as appropriate lighting, the use of calendar and clocks to reduce delirium incidence. Moreover, music therapy have been evaluated as possible tool to reduce delirium, the paper from Jonson and colleagues suggests that music therapy may reduce physiologic variations associated to delirium as hearth rate and systolic blood pressure, however it provides no direct evidence of delirium prevention [57].

This is the first study investigating the possible role of DT in the prevention of delirium in patients affected by dementia. Here we show that patients treated with DT have a lower incidence of delirium measured by the CAM scale. The exact mechanisms is currently unknown, we hypothesize that DT may act on one of the factors causing delirium, according with the Hospital Elder Life Program this are: orientation, therapeutic activities, early mobilization, vision/hearing optimization, oral volume repletion, and sleep enhancement [58]. Interaction with the doll may be considered as a therapeutic activity catalysing patients’ attention and reducing the risk of delirium.

As major limitation of our study, we acknowledged the difference in psychotropic drugs used in the two groups; however, this difference mirror common clinical practice in the treatment of patients affected by dementia. However we do not find significant difference in drugs used in DT and ST groups, this reduce the bias.

It is noteworthy that the comparison of DT with common clinical practice allow us to generalize our findings.

In conclusion, DT may be an option for the treatment of BPSD in nursing home residents affected by severe to moderate dementia providing a careful evaluation of doll acceptance both from patients and family. On this regard the professional caregiver must be formed in order to correctly present the treatment to the patient and his/her family.

Here we show, for the first time in literature, a possible effect of DT in reducing the incidence of delirium, these data needs to be further explore with an ad hoc designed trial.

Funding. The cultural association Leadership Experience Opportunity (LEO) district 108 donated the dolls.

Acknowledgement.

Valeria Suriano (nurse) and Alice Barberis (nurse) recruited nursing homes residents.

Conflict of interest: the Authors declare that there is no conflict of interest.

Consent to publish: Not Applicable.

Availability of Data and Materials: the datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Author's Contribution: FS enrolled the patients, participate in the study design and data analyses, MM participate in the study design and data analyses, PD designed the study, analyses the data and wrote the first draft of the manuscript.

All authors reviewed the manuscript.

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No competing interests reported.

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