35 Clinical Trials for Various Conditions
The goal of this experimental study is to learn if cognitive stimulation therapy (CST) helps improve cognitive functioning and engagement in individuals with mild-to-moderate dementia who reside in skilled nursing facilities. It will also help introduce CST into long-term care facilities in the Northern Kentucky region and provide evidence to support reimbursement for occupational therapy (OT) services in memory care. The main question it aims to answer is: Is there a significant difference in cognitive functioning and engagement between individuals with mild-to-moderate dementia who reside in skilled nursing facilities and receive cognitive stimulation compared to individuals receiving maintenance-level services? Researchers will compare CST (themed grouped sessions with activites related to their childhood, sounds, word and number games, current affairs, being creative, word association, physical games, quizzes, and orientation) to maintenance-level services (activities performed in the activities room) to see if there is a significant difference in cognition and engagement in residents who receive CST versus their regular maintenance level services. Participants will receive either CST or maintenance-level services for 45-minutes twice weekly for 7-weeks led by two doctor of occupational therapy students under the supervision of a licensed occupational therapist in the state of Indiana and the sites activity director, complete assessments before and after the 7-weeks to measure changes in cognitive function and engagement, along with participating in a screening assessment before the start of the study. This study will also support the OT profession by enhancing practitioners' skills in dementia care and contributing evidence for policy and reimbursement discussions.
This project is the pilot phase of a pragmatic randomized clinical trial comparing outcomes among older adults with Alzheimer's disease and related dementias (ADRD) receiving home-delivered meals. This pilot will test and validate vital elements and procedures including: 1) enrolling persons with ADRD on Meals on Wheels (MOW) programs' waiting lists to receive one of the two types of meals; 2) recruiting a subsample of participants and caregivers to participate in telephone interviews; 3) extracting and transferring program data to Brown University; 4) linking participant data with Medicare and nursing home assessment data. Persons with ADRD receiving meals and their caregivers will be recruited to pilot interview guides. The interviews will provide important process and mechanistic information about the experiences receiving meals and participants' outcomes.
The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.
This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.
The purpose of this study is to adapt, pilot test, and evaluate the feasibility, acceptability, and preliminary effectiveness of DIGNITY (Decision-making In aGing and demeNtIa for auTonomY) for Preference-Based Care in Nursing Homes as a new evidence-based intervention to support nursing home staff to safely honor care and activity preferences of residents' living with dementia in rural, typically under resourced nursing home communities.
This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.
The purpose of this study is to develop a consistent approach to prevent falls with injury in nursing home (NH) residents. A centralized Injury Liaison Service (ILS) will be developed and tested in four nursing home facilities (two in the Durham, North Carolina area and two in the Boston, Massachusetts area). The ILS will combine successful elements of a Fracture Liaison Service (FLS) and video telehealth staff education (ECHO) models with the goal of decreasing injurious falls in nursing home residents. The ILS Program has four main components: 1. Automated identification of NH residents at high risk for falls with injury 2. Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications 3. Video telehealth sessions to educate staff 4. Shared decision making with residents and/or families. The central hypothesis of this study is that the ILS model will reduce injurious falls by changing care delivery in two areas: deprescribing psychoactive and cardiometabolic drugs to reduce falls, and increasing osteoporosis treatment to prevent injury in the setting of a fall. Qualitative interviews will be conducted with nursing home staff to gain a better understanding of effective and non-effective injury prevention strategies. Information from these interviews will be incorporated into the study design. Outcome measures will focus on acceptability, demand, practicality, and feasibility of the program, as well as safety.
This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up to 12-months) regarding goals of care preferences, advance care planning, and treatments received. The primary outcome is decisions not to be hospitalized at 6 months.
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Since the "National Partnership to Improve Dementia Care" debuted in 2012, almost all long-stay psychoactive prescribing has been graded by CMS, which has correlated to decreased use. However, some national data suggest that while these psychoactive medications are being used less, prescriptions of mood-stabilizing antiepileptic drugs (AEDs) have increased. Unlike all other psychoactive medications, AEDs prescribed in nursing homes are not mandatorily reported to CMS or graded in a quality-measure.
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities. As a result pain in people with moderate to severe dementia often goes under-recognised and undertreated. PainChek® is a technology-enabled, observational pain assessment tool, in the form of a mobile application designed specifically to assist healthcare professionals and professional caregivers assess pain in people with moderate severe dementia. In this study the investigators aim to assess the performance of PainChek® in assessing pain in nursing home residents with moderate to severe dementia compared to the Abbey Pain Scale.
The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.
The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies.
This study aims to analyze how warning letters sent to physicians prescribing high levels of the antipsychotic quetiapine affected the health and quality of life of their patients with dementia. Using a randomized controlled trial conducted by the Centers for Medicare and Medicaid Services (CMS) in 2015, this secondary study looks at the effects of potential de-prescribing of antipsychotics by study physicians induced by the letters. The central question is whether the intervention led to better health and quality of life outcomes by encouraging more guideline-concordant care and whether changes in physicians' prescription behavior caused unintended harms.
This Our Care Wishes- Dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (SDMs) and testing the usability and acceptability among nursing home residents and SDMs.
Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this study will assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) and their care-partners newly admitted to nursing homes (NHs) for post-acute care.
The purpose of this trial is to test the effects of a personalized music intervention (Music and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with dementia.
The purpose of this trial is to test the effects of a personalized music intervention (Music and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with dementia.
Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach. This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident. This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.
The purpose of this study is to test three hand feeding techniques that can be used to provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand feeding, and hand-under-hand feeding.
This cluster randomized controlled trial is to examine whether decision support for goals of care can improve quality of communication and decision-making and improve the quality of palliative care for nursing home residents with advanced dementia.
This study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four VA Community Living Centers (CLCs).
This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.
Approximately 40,000 older Veterans who have complex care needs (for example, a combination of severe cognitive, physical, and mental health conditions) receive long-term care in VA Community Living Centers (CLCs). However, CLC staff members rarely receive specialized training in how to best engage and interact with these Veterans, which can lead to poor care quality, worsening of symptoms, staff burnout, and low morale throughout a facility. We have developed a unique, mind-body, group movement program for Veterans with cognitive impairment called Preventing Loss of Independence through Exercise (PLIÉ) and found that it has physical, cognitive, social and emotional benefits in CLC residents. We recently taught 50 staff members from a variety of professions in 5 CLCs to lead PLIÉ classes. The study will enable us to test whether the PLIÉ,LC staff training program improves outcomes for residents and to learn about the success and sustainment of the training.
The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care.
This study will test feasibility and preliminary effects of an automated and performance-based feedback app (Speeko for Elderspeak) that detects and reports the use of diminutives (terms of endearment such as honey, dearie, and sweetie), prevalent elderspeak terms linked to BPSD. Building on proof of concept established in the laboratory, the app will demonstrate feasibility at the point-of-care. Next, a clinical trial (N= 6NHs) will be conducted to test preliminary efficacy of the app for amplifying reductions in diminutives use for NH staff completing the CHATO training (3 online modules).
The purpose of this study is to examine the efficacy of non-pharmacological ways to treat agitated behaviors in nursing home residents with dementia. The hypothesis is that non-pharmacological interventions will be more effective than placebo in decreasing such behaviors.