Rationale for the study
Patients with dementia show a high prevalence of psychological and behavioral symptoms (BPSD), which are some of the most complex, stressful and costly aspects of dementia care. Scientific evidence and clinical practice show that there is no one-size-fits-all solution and that approaches tailored to both the patient and the caregiver are needed. For this reason, it is very beneficial to describe a conceptual model that integrates factors related to the person with dementia, the caregiver and the environment, which, in turn, can serve as a basis for evaluating behavior, as well as for the design and implementation of non-pharmacological treatments for the management of BPSD.
On the other hand, when symptoms are not present, the model could help to design preventive measures with caregivers: suggestions to improve the use of available resources, control symptoms more effectively, detect the needs of the person with dementia, implement structured routines or increase behavioral activation.
In order to achieve this, it is necessary to obtain the best and most complete clinical information available on BPSD. In this sense, studying a wide selection of variables in different sites where patients reside could help to improve the characterization that we have of them, as well as to discover underlying relationships between the psychosocial factors previously mentioned, since these probably differ significantly between the different residential sites and population groups (for example: the different roles between formal/informal caregivers, environmental differences, use of psychotropic drugs or containment measures, economic level, follow-up of a cognitive stimulation programme and improvement of activities of daily living (ADL), level of physical activity, health care…), which could contribute to explain differences in outcomes in terms of observed prevalence or severity.
Objectives
This study aims at a systematic approach to the knowledge of BPSD that considers the medical, psychological, familial, social and institutional aspects present in their onset and maintenance, so that it contributes to improving our understanding of them and allows the development of strategies for their diagnosis, prevention and treatment.
Specific objectives
1.- To study the prevalence and severity of BPSD in patients treated in three different settings: homes, day care centers and nursing homes. To analyze the possible differences found between the three groups and their relationship with the socio-demographic and clinical characteristics of both patients and caregivers in each of the three spheres.
2.- To study the prevalence and severity of BPSD in patients treated by two populations of caregivers: formal and informal. To analyze the possible differences found in both groups and their relationship with the socio-demographic and clinical characteristics of both the patients and the caregivers themselves.
3.- To study the prevalence and severity of BPSD in the four most frequent types of dementias: Alzheimer’s disease, vascular dementia, dementia with Lewy bodies and frontotemporal dementia. To analyze the possible differences found between the four groups and their relationship with the socio-demographic and clinical characteristics of both patients and caregivers. To also analyze the possible differences found in each of the three care settings.
4.- To study the prevalence and severity of BPSD in different stages of dementia according to the Clinical Dementia Rating (CDR) scores in the four most frequent types of dementia. To analyze possible differences found. To also analyze the possible differences found in each of the three care settings.
5.- To study the prevalence and severity of BPSD in early-onset and late-onset Alzheimer´s disease. To analyze the possible differences found between the two types of dementias and their relationship with the socio-demographic and clinical characteristics of both patients and caregivers.
6.- To study the association of polymorphisms of the APOE gene with the presence of BPSD in Alzheimer´s disease and other dementias.
7.- To study the association of genetic polymorphisms with the presence of BPSD in Alzheimer´s disease and other dementias. The role of APOE will be determined, as well as the functional variants that affect the neuroendocrine system such as the MAO, COMT, OPRM1 and SIRPB1.
8.- To study the levels of burden, anxiety and depression in two populations of caregivers: formal and informal. To analyze the possible differences found in both groups and their relationship with different socio-demographic and clinical characteristics of both the caregivers themselves and the patients they treat, and especially with the prevalence and severity of the different BPSD.
9.- To study the relationship between caregiver burden and levels of anxiety and depression and whether the coping strategies used mediate this relationship. To analyze if this relationship is different depending on the formal or informal nature of the caregiver and the use of different coping strategies by both populations.
10.- To study whether caregiver burden is independently related to the presence of BPSD and whether this relationship is mediated by the coping strategies used by the caregiver. Analyze if this relationship is different depending on the formal or informal nature of the caregiver and the use of different coping strategies by both populations.
11.- To study the relationship between caregiver burden and levels of anxiety and depression and whether the caregiver’s perception of self-efficacy mediates this relationship. Analyze if this relationship is different depending on the formal or informal nature of the caregiver.
12.- To study whether caregiver burden is independently related to the presence of BPSD and whether this relationship is mediated by the caregiver’s perception of self-efficacy. To Analyze whether this relationship is different depending on the formal or informal nature of the caregiver.
13.- To study the prevalence of undiagnosed acute and treatable diseases in the patient and their relationship with the presence of BPSD. To analyze if this relationship is different depending on the three possible settings where the patient resides.
14.- To assess the presence of pain in patients and its relationship with the presence of BPSD. To analyze if this relationship is different depending on the three possible settings where the patient resides.
Methodology
Multicenter, observational, cross-sectional and analytical epidemiological study. No intervention will be performed on patients.
The study population will consist of patients with mild, moderate or severe dementia treated in the following public or private settings throughout the national territory:
• Outpatients attending Day Care Centers.
• Patients who live at home and do not attend Day Care Centers.
• Patients living in Nursing Homes.
An anonymized database will be generated to which only researchers related to the project will have access. Adequate statistical analyses will be carried out to ascertain the prevalence and severity of BPSD in patients with dementia in the various settings studied and their relationship with a wide range of clinical manifestations of dementia will be analyzed, as well as the repercussions on their caregivers.
Ethical aspects
Researchers should conduct the study in accordance with the principles of the Helsinki Declaration. Copies of the Helsinki Declaration can be obtained through the World Medical Association website at htpp://www.wma.net/e/policy/b3.htm.
The study will be conducted in accordance with the protocol and standard operating procedures to ensure compliance with Good Clinical Practice standards as described in the International Conference on Harmonisation for Good Clinical Practice 1996 Harmonised Tripartite Standards (http://www.ich.org/cache/compo/475-272-1.html#E6).
In accordance with international standards relating to carry out of epidemiological studies, contained in the International Guidelines for Ethical Reviews of Epidemiological Studies (Council for the International Organizations of Medical Sciences-CIOMS-Geneva, 1991) and the recommendations of the Spanish Society of Epidemiology on the review of ethical aspects of epidemiological research, such studies should, except in certain specific cases, be subject to review by an independent committee. Therefore, the present study will be evaluated by a reference Clinical Research Ethics Committee (CREC). The reference CREC will be that of the Coordinating Committee for the Ethics of Biomedical Research in Andalusia.
In accordance with article 7 of Royal Decree 223/2004, the consent of the patient’s legal representative must be obtained after having been informed of the possible risks, inconveniences and benefits of the study. The consent must reflect the presumed will of the subject and may be withdrawn at any time. When the subject’s conditions permit, the subject must also give consent.
All information concerning the identity of patients shall be treated as confidential for all purposes. The identity of patients may not be disclosed except as necessary for treatment, follow-up or safety.