Treatment Trials

104 Clinical Trials for Various Conditions

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COMPLETED
Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities
Description

The goal of this clinical trial is to test the use of head-mounted display (HMD) augmented reality (AR) in older adults residing in long term care communities. The main questions it aims to answer are: what is the feasibility, acceptability, and satisfaction of HMD AR vs two-dimensional audio-video communication? Older adults and their designated family member will complete HMD AR activities in 8 session visits over 4 weeks. Researchers will compare HMD AR to 2-D audio-visual (AV) comparison group on feasibility, acceptability, and satisfaction with the interactive communication technology.

Conditions
ACTIVE_NOT_RECRUITING
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
Description

This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.

RECRUITING
Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities
Description

To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications). This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

ENROLLING_BY_INVITATION
Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
Description

Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.

COMPLETED
All About Me: An Intervention to Ease the Transition to Long Term Care
Description

This Phase I study will involve initial development and evaluation of an innovative cross-platform software app called All About Me (AAM), which will consist of Serious Digital Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care and enable residents to improve relationships with one another and with staff, thereby promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App, and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on engagement/affect.

ACTIVE_NOT_RECRUITING
Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities
Description

The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia. Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.

Conditions
RECRUITING
Use of Socially Assistive Robots for Long Term Care Older Adults With Cognitive Impairment and Apathy
Description

The objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. Earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. First, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. Second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. Researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.

COMPLETED
CONFIDENT: Supporting Long-term Care Workers During COVID-19
Description

The CONFIDENT Study is an online three-arm randomized trial that aims to help long-term care workers in the United States feel more confident about the Coronavirus Disease 2019 (COVID-19) vaccines. The study will compare two different interventions to usual online information (website of the Centers for Disease Control and Prevention). The first intervention is a Dialogue-Based Webinar where people can interact and ask questions about the vaccines. The second intervention is a Social Media Website that will feature curated content about the vaccines from popular social media platforms. Participants will be asked to completed four online surveys. The first survey will be completed pre-intervention and immediately upon study enrollment (Time 0). Participants will be randomized to a trial arm at the end of the Time 0 survey. Intervention follow-up surveys will be completed 3 weeks post-randomization (Time 1), three months post-randomization (Time 2), and 6 months post-randomization (Time 3).

Conditions
COMPLETED
Dexcom Continuous Glucose Monitoring in Long-term Care
Description

The goal of this study is to determine whether the use of Dexcom Continuous Glucose Monitoring with Glucose Telemetry System (CGM-GTS) with hypoglycemia alarm will facilitate diabetes treatment and reduce the risk of hypoglycemia in insulin and non-insulin treated patients with type 2 diabetes (T2D) in long-term care facilities, when compared to standard of care using capillary point of care testing.

TERMINATED
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)
Description

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

COMPLETED
Worksite Wellness Within Long-term Care Facilities
Description

The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.

ACTIVE_NOT_RECRUITING
Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults
Description

This study seeks to better understand how older adult aging-in-place/long term care decision making and implementation is impacted by age-related changes (e.g. cognition, health literacy, chronic conditions), social influences (e.g. caregivers/supporters), and environmental factors.

COMPLETED
FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care
Description

Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care.

Conditions
COMPLETED
Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care
Description

Our overall objective is to assess the value of Spinal Manipulation Services as compared to Prescription Drug Therapy for long-term management of chronic Law back Pain (LBP). Our central hypothesis is that among aged Medicare beneficiaries with chronic LBP, utilization of SMS offers superior value (to both patient and payer) for long-term care as compared to PDT.

Conditions
COMPLETED
Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding
Description

The ability to find one's way in the world is known as wayfinding. Many older adults who live in senior communities, such as independent living and assisted living residences, find wayfinding very challenging. Often times, these communities are not designed in a way that helps people find their way very easily. When people cannot find their way, they can get lost, be dependent upon others for getting out and about, or even be afraid to leave their rooms. The purpose of this study is to find out if distinctive signs and decorative elements, along with a special type of education called Spaced-Retrieval education, help residents in these communities find their way more effectively. Twelve senior communities will be assigned by chance to one of three conditions, including: 1) control - no change (the community stays the same); 2) signs and decorative elements enhanced; and 3) signs, decorative elements, and special education added. After agreeing to be in the study, the participants will be asked to find their way to certain places in their community four times over a year. Some people will be asked to participate in educational sessions on wayfinding. In addition, some people will be asked to wear a location tracker, (like a fitness tracker), for four weeks during the year. How well people find their way, along with how much they travel about within the communities, will be compared between the three groups. It is hypothesized that those in the communities with special signs and decorative elements will find their way more effectively than those in the control communities. It is also hypothesized that participants in the communities with the special education intervention will find their way better than those without the education. Finally, it is hypothesized that participants in the communities with signs and cues and education will travel about further distances than those in the control communities. The results of the study can help people who have a tendency to get lost find their way more effectively in their community, and this could result in more independence.

COMPLETED
Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
Description

The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.

COMPLETED
Hypertension in Long-Term Care Facilities
Description

This study is exploratory in nature and seeks to describe hypertension diagnosis and management among patients in long-term care (LTC) facilities. Specifically, the primary objective is to: • Identify LTC patients who are diagnosed with hypertension and assess the management and different outcomes of proper control of BP regarding to incidence of falls, cognitive decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents The secondary objectives are to: Describe treatment patterns of hypertension in LTC facilities * Identify patients who are receiving non-pharmacological treatment and effectiveness of this modality of treatment. * Identify different classes of drugs used to treat hypertension in patients staying at LTC facility * Identify different drug adverse effects encountered by patients receiving medical treatment. * Identify patients who achieved normal blood pressure according to current guidelines

Conditions
COMPLETED
Testing the Effectiveness of an Occupation-based Cultural Intervention in Long-term Care
Description

The goals of the proposed research were to: 1. describe the person and environment characteristics and activity patterns of residents in long-term care (LTC) facilities; 2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI) grounded on the results of Aim 1; 3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into LTC facilities relative to a usual activities group; 4. determine the cost-effectiveness of the intervention conducted by in-house staff compared to the control group; and 5. examine person and environment factors as potential moderators of the relationship between treatment condition and adaptation outcomes.

Conditions
UNKNOWN
Immunogenicity of Influenza Vaccine in Long Term Care
Description

The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.

Conditions
COMPLETED
Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
Description

To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility. Hypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group. Hypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.

COMPLETED
ADA Linagliptin in Long Term Care
Description

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Conditions
COMPLETED
Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
Description

The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.

Conditions
COMPLETED
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Description

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Conditions
COMPLETED
Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Description

The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Conditions
UNKNOWN
Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting
Description

The primary purpose of this research study is to evaluate if DermaTherapy® bedding will significantly reduce pressure ulcer incidence by decreasing maceration, friction, and shearing among residents of Nursing Homes.

Conditions
COMPLETED
Detection, Education, Research and Decolonization Without Isolation in Long-term Care Facilities
Description

Our hypothesis for the DERAIL MRSA program is that one can safely remove the colonization risk from nearly all residents (patients) in a way that does not interfere with the desired life-style for persons in these facilities and thereby reduce the risk of infection and lower the cost of care by avoiding preventable disease.

COMPLETED
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
Description

This is an ancillary study to a randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374). In this study, a subset of trial subjects will receive the zoster vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.

COMPLETED
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Description

This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.

COMPLETED
Targeted Infection Control in Long-term Care
Description

This is an interventional study aimed at reducing multi-drug resistance and infections in nursing home (NH) residents. Each year, a staggering 1.5-2.0 million infections occur in NHs. Many of these infections are caused by multiple drug resistant organisms (MDROs) including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and multidrug resistant Gram-negative bacilli (R-GNB). Antimicrobial resistance among common bacteria are adversely affecting the clinical course and exponentially increasing healthcare costs. Recognizing a need for action, legislators, policy makers, and consumer groups are advocating for pathogen-based universal preemptive screening for these MDROs, particularly MRSA in hospitals and NHs. However, implementing this sweeping mandate is controversial, costly, reactive, and not based on empirical evidence. It can result in a 10-20-fold increase in the number of NH residents placed in isolation precautions with the potential for reduced attention by healthcare workers, isolation and functional decline. The investigators proposal evaluates a novel focused approach between 'do nothing' and 'search all and destroy' strategies by targeting a subgroup of NH residents with indwelling devices who are at a high risk of acquiring MDROs and infections. The investigators hypothesize that the investigators targeted infection control program (TIP) will reduce MDRO colonization and infections in NH residents with indwelling devices. This cluster randomized trial will involve 12 NHs; 6 will be randomized to the TIP arm and 6 to the routine care arm. The investigators TIP intervention will include four components.

Conditions
COMPLETED
Effect of Bright Light Treatment On Elders In a Long Term Care Environment
Description

The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will: 1. improve sleep quality 2. improve cognitive scores 3. improve depression scores 4. improve quality of life scores.