Active clinical trials for "Behavioral Symptoms"

Between 13 and 60% of older people who live with Alzheimer's disease (ADRD) in long-term care facilities (LTCFs) manifest vocal behaviours (VB) that may seem inappropriate, e.g. moaning, screaming, calling out. These behaviours may indicate ill-being, disturb others, create feelings of powerlessness in family and formal caregivers, and lead to inappropriate medication. Previous efforts to reduce VB have been largely ineffective. A new approach was developed based on finding the underlying reasons for VB through a partnership between family and formal caregivers. The goals are to reduce VB, enhance older people's well-being, and increase family and formal caregivers' empowerment. The approach was tested in a pilot study of 14 triads comprising an older person living with ADRD, a family caregiver and a formal caregiver. The results were promising; overall, it is feasible to implement the approach in LTCF and it has positive effects on older people, family and formal caregivers. Now the investigators propose to assess the clinical and economic impact of the approach in 20 LTCFs with 108 triads like those in the pilot study. The approach will be implemented in 10 randomly selected "experimental" LTCFs; the other 10 (control group) will continue with their usual practices. The investigators will measure VB frequency and the well-being of the older people before, two and four months after starting the implementation. They will also measure the perceived disruptiveness of VB for family and formal caregivers, their ability to work in partnership and their empowerment relative to VB. The investigators will compare data between the control and experimental LTCFs, and calculate cost-effectiveness based on changes in VB frequency. The proposed three-year project aims to improve the well-being of all involved in LTCF by promoting a better understanding of VB and implementing a solution to optimize care. The investigators believe the findings will provide evidence to justify the wider implementation of the approach in LTCF.

The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training. The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.

The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.

Brief summary Resisted behaviours that occur during showering of People with Dementia (PwD) cause greater discomfort for caregivers and may occur as a result of embarrassment and shame that the person with dementia may be experiencing or even due to a moment of confusion or anxiety. Therefore, it is considered particularly relevant and necessary to provide information and strategies to caregivers of PwD in order to manage the behavioural alterations produced during the shower. One of the strategies currently used in clinical practice to improve the relationship between caregivers and users is the implementation of the Basale stimulation® concept. The stimuli applied from Basale Stimulation® are related to 3 basic areas of development: somatic, vestibular and vibrational. In relation to the development of the showers, they will be carried out from the application of relaxing somatic modelling connected to the somatic area. The aim of this study is to analyse the efficacy of an intervention based on the relaxing somatic modelling technique, framed within the Basale Stimulation® concept, to reduce behavioural disturbances and increase the involvement of the person with moderate to severe dementia during assisted showering. The main caregivers of the PwD, who meet the inclusion criteria will be contacted by sending a study information sheet and an informed consent form. All family members will receive a call to clarify the concepts explained and the study methodology to be carried out. The grooming sessions of all users whose relatives have signed the informed consent form, will be videotaped and a trained technician will fill in the questionnaires for each session based on the analysis of the videos of each intervention. Six intervention sessions will be carried out with each user. An alternating treatment design will be used, applying condition A or B randomly and then counterbalancing. Condition A corresponds to a traditional shower according to the long-term care bathing and grooming protocol and condition B corresponds to the use of relaxing somatic modelling within Basale Stimulation®. The first result obtained will be an increase in the appearance and frequency of behaviours that increase the engagement of the PwD and a decrease in the appearance and frequency of disengagement behaviours during the shower activity in the Basale Stimulation® application sessions. This result will be measured with the Involvement Register (RIE) (García-Soler et al., 2014), adding the measure of frequency of involvement behaviours on a likert scale. The second expected outcome will be the decrease in the occurrence, frequency and intensity of behavioural disturbances during the Basale Stimulation®-based intervention showers. This outcome will be measured with a questionnaire based on the Neuropsychiatric Inventory Questionnaire (NPI-Q)(Boada et al., 2002) and the Agitated Behavior in Dementia scale (ABID) (Logsdon et al., 1999), recording the number of times a disruptive behaviour appears, the frequency with which it appears during the shower, and the intensity of the behaviour on a Likert scale. In addition, the user's functional status measured with the Barthel Index, his cognitive status measured with the Mini-Mental State Examination and his behaviour through the Agitation Inventory of the Elderly will be taken into account. Intervention description The relaxing somatic modelling technique will be applied, framed within the concept of Basal Stimulation®. To do this, the user remains seated and the parts of the body that are not being washed at that moment are covered with a towel, favouring the preservation of the user's privacy. The user is lathered up with soft mittens previously moistened with lukewarm water and lathered up. This process shall be carried out starting from the shoulder in a proximal to distal direction on the upper limbs, lower limbs and trunk (taking into account the sagittal anatomical plane) and in a cephalic to caudal direction (taking into account the transverse anatomical plane). Subsequently, rinsing is carried out following the same guidelines as described above, using moistened soft mittens. Finally, intimate hygiene is performed with a disposable soapy sponge and the soap is rinsed off again with moistened soft terrycloth mittens. Throughout the whole process, the activity is explained to the user.

This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation.

This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.

The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: Agitation Cognitive changes Physical changes (i.e. labs, ekg, physical exam)

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains. The CAREPATH outcomes can be summarized as: An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc). Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.