PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases

IntroductionAlzheimer's Disease and Related Diseases (ADRD) are associated with a caregiver burden that increases with the progression of the disease. Psychosocial interventions reported a moderate improvement on caregivers' burden. Patients with ADRD and their older caregivers are also exposed to a higher risk of developing drug-related problems. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of caregivers.MethodsThe PHARMAID study is a 18-month randomized controlled trial that started in September 2016. This paper describes the study protocol. PHARMAID plans to enroll 240 dyads, i.e. ADRD patients and caregivers, whose inclusion criteria are: outpatient with mild or major neurocognitive disorders due to ADRD, living at home, receiving support from a family caregiver. Three parallel groups will compare a control group with two experimental groups: psychosocial intervention and integrated pharmaceutical care at a psychosocial intervention. The main outcome is the caregiver's burden assessed by the Zarit Burden Index at 6, 12 and 18 months.DiscussionThis is the first trial designed to assess the specific impact of the integration of pharmaceutical care in a multidisciplinary psychosocial program on the caregiver's burden. The results will inform policymakers on strategies to implement in the near future.Trial Registration number: [ClinicalTrials.gov: NCT02802371] Registered in June 2016.     

A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial

Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.     

An Interprofessional Virtual Healthcare Neighborhood for Caregivers of Elderly With Dementia

Healthcare websites are vital resources for individuals with limited access to healthcare. The 6 million United States citizens with dementia and their caregivers are an example of a population in need of the assistance provided by interactive websites. Dementia often confines the patient and caregiver to the home, thus creating caregiver burden and stress that often results in institutional care. This article describes the nurse practitioner‒developed Virtual Healthcare Neighborhood, a web-based platform. The Virtual Healthcare Neighborhood provides an interprofessional approach to using technology to provide education, peer support, and healthcare consultation to caregivers of homebound older adults with dementia.     

Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial

Among over 5 million people in the USA with dementia, neuropsychiatric symptoms (NPS) are almost universal, occurring across disease etiology and stage. If untreated, NPS can lead to significant morbidity and mortality including increased cost, distress, depression, and faster disease progression, as well as heightened burden on families. With few pharmacological solutions, identifying nonpharmacologic strategies is critical. We describe a randomized clinical trial, the Dementia Behavior Study, to test the efficacy of an activity program to reduce significant existing NPS and associated caregiver burden at 3 and 6 months compared to a control group intervention. Occupational therapists deliver 8 in-home sessions over 3 months to assess capabilities and interests of persons with dementia, home environments, and caregiver knowledge, and readiness from which activities are developed and families trained in their use. Families learn to modify activities for future declines and use strategies to address care challenges. The comparison group controls for time and attention and involves 8 in-home sessions delivered by health educators who provide dementia education, home safety recommendations, and advanced care planning. We are randomizing 250 racially diverse families (person with dementia and primary caregiver dyads) recruited from community-based social services, conferences and media announcements. The primary outcome is change in agitation/aggression at 3 and 6 months. Secondary outcomes assess quality of life of persons with dementia, other behaviors, burden and confidence of caregivers, and cost and cost effectiveness. If benefits are supported, this activity intervention will provide a clinically meaningful approach to prevent, reduce, and manage NPS.     

Caregiver perspectives on a smart home-based socially assistive robot for individuals with Alzheimer’s disease and related dementia

Abstract

Purpose: Innovative assistive technology can address aging-in-place and caregiving needs of individuals with Alzheimer’s disease and related dementia (ADRD). The purpose of this study was to beta-test a novel socially assistive robot (SAR) with a cohort of ADRD caregivers and gather their perspectives on its potential integration in the home context.

Methods: The SAR involved a programmable research robot linked with commercially available Internet of things sensors to receive and respond to care recipient’s behaviour. Eight caregivers observed the SAR perform two care protocols concerning the care recipient’s daily routine and home safety, and then participated in a focus group and phone interview. The researchers used grounded theory and the Unified Theory of Acceptance and Use of Technology as a framework to gather and analyse the data.

Results: The caregivers’ asserted the potential of the SAR to relieve care burden and envisioned it as a next-generation technology for caregivers. Adoption of the SAR, as an identified theme, was subject to the SAR’s navigability, care recipient engagement, adaptability, humanoid features, and interface design. In contrast, barriers leading to potential rejection were technological complexity, system failure, exasperation of burden, and failure to address digital divide.

Conclusion: From a broader outlook, success of SARs as a home-health technology for ADRD is reliant on the timing of their integration, commercial viability, funding provisions, and their bonding with the care recipient. Long-term research in the home settings is required to verify the usability and impact of SARs in mediating aging-in-place of individuals with ADRD.

• IMPLICATIONS FOR REHABILITATION

• Socially assistive robots (SARs), an emerging domain of assistive technology, are projected to have a crucial role in supporting aging-in-place of individuals with Alzheimer's disease and related dementia (ADRD).

• Caregivers of individuals with ADRD who observed and interacted with a novel SAR asserted their acceptance of the technology as well as its scope and feasibility for the upcoming generation of caregivers.

• Navigability, care recipient engagement, adaptability, humanoid features, and interface design were stated to be critical factors for SAR's acceptance by caregiver and care recipient dyads.

• In contrast, technological complexity, system failure, exasperation of burden, and failure to address digital divide are detrimental to SAR's adoption.

• Several design and implementation requirements must be considered towards the full-scale development and deployment of the SARs in the home context.

     

Informal care in Huntington's disease: Assessment of objective-subjective burden and its associated risk and protective factors

BackgroundBecause of the genetic transmission of Huntington's disease (HD), informal caregivers (ICs, i.e., non-professional caregivers) might experience consecutive and/or concurrent caregiving roles to support several symptomatic relatives with HD over their life. Additionally, some ICs might be HD carriers. However, whether family burden of care is associated with specific factors in HD remains poorly studied.ObjectiveTo provide a quantitative view of the IC burden and identify associated factors.MethodsThis was a cross-sectional assessment of home-dwelling symptomatic HD individuals (from REGISTRY and Bio-HD studies) and their primary adult ICs, including the HD individual's motor, cognitive, behavioral, functional Unified Huntington's Disease Rating Scale score; IC objective burden (quantification of IC time in activities of daily living, instrumental activities of daily living and supervision, using the Resource Utilization in Dementia instrument), IC subjective burden (Zarit Burden Inventory), and ICs’ social economic functioning and use of professional home care.ResultsWe included 80 ICs (mean [SD] age 57 [12.9] years, 60% women) in charge of 80 individuals with early to advanced stage HD (mean age 56 [12.6] years, 51% men). The mean hours of informal care time was high: 7.3 (7.9) h/day (range 0–24); the mean professional home care was 2.8 (2.8) h/day (range 0.1–12.3). This objective burden increased with higher functional loss of the HD individual and with more severe cognitive-behavioral disorders. The mean subjective burden (35.4 [17.8], range 4–73) showed a high level since the earliest stage of HD; it was associated with HD duration (mean 9.2 [4.7] years) and with aggressive symptoms in individuals (44% of cases). The burden was partially related to the multiplex caregiving status (19%). Protective factors lowering the IC burden included the absence of financial hardship (57%), a strong social network (16%) and keeping active on the job market outside home (46%).ConclusionsThe objective-subjective burden of ICs related to changing patterns of neuro-psychiatric symptoms and mitigating environmental characteristics around the HD individual–caregiver dyads.     

Family Caregivers for People with Dementia and the Role of Occupational Therapy

ABSTRACT. As the population continues to age, the prevalence of Alzheimer's disease and related dementia (ADRD) will increase, along with the number of informal (e.g., family and friends) caregivers needed. The negative physical, mental, and financial impact providing such care has on the caregiver, in addition to the tremendous economic value of their care, has been well documented. Furthermore, the quality of care and the amount of care that is provided has also been shown to influence the overall health and wellbeing of the care receiver and caregiver. The current qualitative, phenomenological study explored the experience of these family caregivers and how occupational therapists can better assist caregivers for people who have dementia. Five themes emerged: Personal Changes, Obstacles/Challenges, Support Network, Emotions, and Healthcare Thoughts. A discussion of the themes and how occupational therapists can assist these caregivers is included.     

A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

BackgroundThe addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care—meaning basic palliative care services provided by clinicians who are not palliative care specialists—is an alternative approach that has not been rigorously evaluated.MethodsA cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania. Existing oncology nurses are trained to provide symptom management and emotional support, engage patients and families in advance care planning, and coordinate appropriate care using evidence-based care management strategies. The trial will assess the impact of CONNECT versus standard oncology care on patient quality of life (primary outcome), symptom burden, and mood; caregiver burden and mood; and healthcare resource use.DiscussionThis trial addresses the need for more accessible models of palliative care by evaluating an intervention led by oncology nurses that can be widely disseminated in community oncology settings. The design confronts potential biases in palliative care research by randomizing at the practice level to avoid contamination, enrolling patients prior to informing them of group allocation, and conducting blinded outcome assessments. By collecting patient, caregiver, and healthcare utilization outcomes, the trial will enable understanding of the full range of a primary palliative care intervention's impact.     

Caregiver strain and factors associated with caregiver self-efficacy and quality of life in a community cohort with multiple sclerosis

Purpose. To describe the level of caregiver strain and factors associated with caregiver self-efficacy and quality of life (QoL) in a community cohort with multiple sclerosis (MS).

Method. A cross-sectional survey of 62 informal caregivers and 101 participants with confirmed MS and quantified physical and cognitive disability recruited from a tertiary hospital MS database. Structured interviews conducted at home using standardized assessments to measure: (i) Caregiver strain and subjective burden of care; (ii) participant with MS and caregiver QoL and self-efficacy; and (iii) participant with MS level of depression, anxiety and stress.

Results. The mean caregiver age was 54 years (range 37 – 62). The mean caregiver strain score was 5.63 (SD 3.63). Twenty-six of 62 (42%) caregivers reported strain for items such as emotional adjustments, demands on time, change in personal plan and disrupted sleep. Caregiver burden was higher in those caring for the more severely affected persons with MS, especially those with higher depression, anxiety and stress levels. The caregiver strain correlated with a lower QoL in both the person with MS and their caregiver, but not with their self-efficacy scores.

Conclusion. Caregivers of persons with MS reporting high levels of caregiver strain experienced a lower QoL and were caring for persons with MS with a lower QoL and higher levels of depression and anxiety. Interventions to reduce caregiver strain and burden in those at risk are necessary to reduce poor outcomes among both caregivers and care recipients with MS.     

Palliative Care as a Primary Therapeutic Approach in Advanced Dementia: A Narrative Review

PurposeThe goal of this narrative review was to identify and summarize the ways in which palliative care could benefit patients who have advanced dementia.MethodsThis case-based discussion article examines current literature on palliative care for dementia.FindingsDementia is an incurable, progressive disease that affects millions of subjects. The prevalence has grown in the last decade and is projected to continue on this trajectory. In the later stages of dementia, subjects require increasing levels of care due to severe cognitive and functional impairment. Although the field of palliative medicine focuses on improving the quality of life of patients with life-limiting illnesses, many patients with advanced dementia do not receive palliative care services.ImplicationsPalliative care has been shown to improve patient and caregiver satisfaction, quality of life, and symptom burden at the end of life. Patients with advanced dementia would benefit from increased access to palliative care.     

Pain Management in Home Health Care: Relationship With Dementia and Facility Admissions

BackgroundPain is common yet under-studied among older Medicare home health (HH) patients with Alzheimer's disease and related dementias (ADRD).AimsExamine (1) the association between ADRD and severe pain in Medicare HH patients; and (2) the impact of severe pain and ADRD on unplanned facility admissions in this population.DesignAnalysis of the Outcome and Assessment Information Set (OASIS) and Medicare claims data.Settings/Participants6,153 patients ≥65 years receiving care from a nonprofit HH agency in 2017.MethodsStudy outcomes included presence of severe pain and time-to-event measures of unplanned facility admissions (hospital, nursing home, or rehabilitation facilities). ADRD was identified using ICD-10 diagnosis codes and cognitive impairment symptoms. Logistic regression and Cox proportional hazard models were used to examine, respectively, the association between ADRD and severe pain, and the independent and interaction effects of severe pain and ADRD on unplanned facility admission.ResultsPatients with ADRD (n = 1,525, 24.8%) were less likely to have recorded severe pain than others (16.4% vs. 23.6%, p < .001). Adjusting for demographics, comorbidities, mental and physical functional status, and use of HH services, having severe pain was related to a 35% increase (hazard ratio [HR] = 1.35, p = .002) in the risk of unplanned facility admission, but the increase in such risk was the same whether or not the patient had ADRD.ConclusionsHH patients with ADRD may have under-recognized pain. Severe pain is a significant independent predictor of unplanned facility admissions among HH patients.     

Caregiver care

In 2009, nearly 66 million Americans (three in 10 U.S. households) reported at least one person providing unpaid care as a family caregiver. More adults with chronic conditions and disabilities are living at home than ever before, and family caregivers have an even higher level of responsibility. Caring for loved ones is associated with several benefits, including personal fulfillment. However, caregiving is also associated with physical, psychological, and financial burdens. Primary care physicians can aid in the identification, support, and treatment of caregivers by offering caregiver assessments-interviews directed at identifying high levels of burden-as soon as caregivers are identified. Repeat assessments may be considered when there is a change in the status of caregiver or care recipient. Caregivers should be directed to appropriate resources for support, including national caregiving organizations, local area agencies on aging, Web sites, and respite care. Psychoeducational, skills-training, and therapeutic counseling interventions for caregivers of patients with chronic conditions such as dementia, cancer, stroke, and heart failure have shown small to moderate success in decreasing caregiver burden and increasing caregiver quality of life. Further research is needed to further identify strategies to offset caregiver stress, depression, and poor health outcomes. Additional support and anticipatory guidance for the care recipient and caregiver are particularly helpful during care transitions and at the care recipient's end of life.     

Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure

BackgroundUncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S. population. Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care.Aims/objectivesTo compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research.MethodsThe design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18–85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects.ConclusionThis pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.     

Do Caregiver Experiences Shape End-of-Life Care Perceptions? Burden,Benefits, and Care Quality Assessment

ContextResearchers, hospices, and government agencies administer standardized questionnaires to caregivers for assessing end-of-life care quality. Caregiving experiences may influence end-of-life care quality reports, which have implications for caregiver outcomes, and are a clinical and policy priority.ObjectivesThis study aims to determine whether and how caregivers' end-of-life care assessments depend on their burden and benefit perceptions.MethodsThis study analyzes data from 391 caregivers in the 2011 National Study of Caregiving and their Medicare beneficiary care recipients from the 2011–2016 National Health and Aging Trends Study. Caregivers assessed five end-of-life care aspects for decedents. Logistic regression was used and predicted probabilities of caregivers positively or negatively assessing end-of-life care based on their burden and benefit experiences calculated. Analyses adjusted for caregiver and care recipient demographic and health characteristics.ResultsNo or minimal caregiving burden is associated with ≥0.70 probability of caregivers reporting they were always informed about the recipient's condition and that the dying person's care needs were always met, regardless of perceived benefits. High perceived caregiving benefit is associated with ≥0.80 probability of giving such reports, even when perceiving high burden.ConclusionCaregiver burden and benefit operate alongside one another regarding two end-of-life care evaluations, even when years elapse between caregiver experience reports and care recipient death. This suggests that caregiver interventions reducing burden and bolstering benefits may have a positive and lasting impact on end-of-life care assessments.     

Tailored music listening intervention to reduce sleep disturbances in older adults with dementia: Research protocol

Sleep disruption in older adults living with Alzheimer's disease and related dementias (ADRD) is debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden. Given the potentially harmful side effects of pharmacologic treatment, nonpharmacologic approaches, such as music, may provide a safer alternative to reducing sleep disruption in this vulnerable population. A growing body of literature suggests that calming tailored music may improve sleep quality in older adults with memory loss, but its efficacy has not been demonstrated in older adults with ADRD in the community, where most older adults with ADRD live. If shown to be feasible and acceptable, tailored music interventions can then be tested for efficacy in reducing sleep disruption. This protocol details a wait-list randomized controlled trial (NCT04157244), the purpose of which is to test the feasibility, acceptability, and examine the preliminary efficacy of a tailored music listening intervention in older adults with ADRD who report sleep disruption. Music selections will be tailored to the music genre preferences of older adults with ADRD and account for known sleep-inducing properties. The feasibility of processes that is key to the success of the subsequent study will be examined. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective (proxy-reported) sleep quality measures. In addition, qualitative data will be solicited, examining the acceptability and satisfaction with the intervention by individuals with ADRD.     

Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial

BackgroundFailure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.MethodsA mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania.Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.DiscussionThis trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.     

Translation of the Care of Persons with Dementia in their Environments (COPE) intervention in a publicly-funded home care context: Rationale and research design

BackgroundDementia is the leading cause of loss of independence in older adults worldwide. In the U.S., approximately 15 million family members provide care to relatives with dementia. This paper presents the rationale and design for a translational study in which an evidence-based, non-pharmacologic intervention for older adults with dementia and family caregivers (CGs) is incorporated into a publicly-funded home care program for older adults at risk for nursing home admission.MethodsThe 4-month Care of Persons with Dementia in their Environments (COPE) intervention is designed to optimize older adults' functional independence, and to improve CG dementia management skills and health-related outcomes. COPE features 10 in-home occupational therapy visits, and 1 in-home visit and 1 telephone contact by an advanced practice nurse. COPE was deemed efficacious in a published randomized clinical trial. In the present study, older adults with dementia enrolled in the Connecticut Home Care Program for Elders (CHCPE) and their CGs are randomly assigned to receive COPE plus their ongoing CHCPE services, or to continue receiving CHCPE services only.OutcomesThe primary outcome for older adults with dementia is functional independence; secondary outcomes are activity engagement, quality of life, and prevention or alleviation of neuropsychiatric symptoms. CG outcomes include perceived well-being and confidence in using activities to manage dementia symptoms. Translational outcomes include net financial benefit of COPE, and feasibility and acceptability of COPE implementation into the CHCPE. COPE has the potential to improve health-related outcomes while saving Medicaid waiver and state revenue-funded home care program costs nationwide.     

Informal caregivers of persons with dementia,their use of and needs for specific professional support: a survey of the National Dementia Programme

Background  

This paper describes both the use of and needs for informal caregivers of people with dementia, based on a questionnaire survey organized within the National Dementia Programme in the Netherlands. The National Dementia Programme is a quality collaborative of the Dutch Alzheimer's Association, the Institute of Quality of Healthcare (CBO) and the Knowledge Centre on Ageing (Vilans), instigated by the Ministry of Health, Welfare and Sport, to improve integrated care for people with dementia and their informal caregivers. The support needs of informal caregivers are important to improve caregiver well-being and delaying institutionalization of the person with dementia.