Treatment Trials

53 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Underutilization of Hospice Care in Older Black Adults
Description

This study will sample older Black adults to test their knowledge and opinions of hospice.

COMPLETED
Developing and Pilot Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers
Description

The investigators hypothesize that culturally based educational videos for Puerto Rican and African American home hospice caregivers will better inform caregivers in managing symptoms, preparedness, self-efficacy, and competence.

ACTIVE_NOT_RECRUITING
Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care
Description

The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care. -The name of the study drug involved in this study is Psilocybin

COMPLETED
The ACTIVE Intervention to Improve Hospice Care
Description

The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.

Conditions
COMPLETED
Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
Description

The goal of this research study is to learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients.

TERMINATED
Caregiver Assessments of the Quality of Home Hospice Care
Description

The Objectives are to administer the Family Evaluation of Hospice Care (FEHC) questionnaire and The Texas Revised Inventory of Grief (TRIG) to caregivers previously enrolled into the parent grant and conduct supplemental analyses to: 1. examine cross-ethnic differences in the caregivers' quality of hospice care assessments. 2. investigate the association between parenteral hydration status of the patient and the quality of care assessments provided by the caregivers after death. 3. examine the association between levels of grief (as measured by the TRIG) and the quality of hospice care assessments provided by the caregiver.

Conditions
COMPLETED
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study
Description

The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.

Conditions
COMPLETED
A Problem Solving Intervention for Hospice Caregivers
Description

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

WITHDRAWN
HoPE (Hospice Preparation and Education)
Description

The investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice Preparation and Education) web-based tool versus usual care to assess: Technology usability (primary), study feasibility (secondary), user acceptability (secondary), and hospice service conversion rate (exploratory). Technology usability will be assessed through a one-time quantitative survey using established instruments. Study feasibility and user accessibility will be assessed through trial enrollment and retention alongside analytics assessing tool usage (e.g. time spent on each page of the website). Conversion rate is the percent of patients introduced to hospice who eventually enroll. The investigators will evaluate in an exploratory manner the differential effect of HoPE versus usual care.

Conditions
RECRUITING
The COMPASSION Study
Description

The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

RECRUITING
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
Description

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.

COMPLETED
Aromatherapy Protocol for Pain Reduction in Hospice Patients
Description

The purpose of this study is to introduce aromatherapy with current pain medication protocols to see if it improves patient satisfaction and reduces pain in hospice care patients.

Conditions
UNKNOWN
Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
Description

Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

COMPLETED
E-training of Inmate Peer Caregivers for Enhancing Geriatric and End-of-life Care in Prisons
Description

The mission of corrections is to provide care, custody, and control for incarcerated individuals. United State prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase I project focuses on research and development of highly interactive computer-based learning modules for inmate peer caregivers to promote an integrated systems approach to enhancing the care of the aged and dying in prisons.

Conditions
COMPLETED
Enhancing Care of the Aged and Dying in Prisons Ph II
Description

The mission of corrections is to provide custody, control and care for incarcerated individuals. United States prisons are required by constitutional law to provide adequate care for growing numbers of older inmates who will likely spend their final days in prison. This Phase II project focuses on the correct users accessing correct learning strategies in the correct setting (i.e., interdisciplinary prison staff accessing high quality products designed to educate and lead practice change initiatives within the walls of prisons), by continuing research and development of a learning system that promotes an integrated systems approach to enhancing the care of the aged and dying in prisons.

Conditions
COMPLETED
PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device
Description

The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart-so-called destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding. Most of these patients have other medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity at all times. A caregiver is required, which often places stress on loved ones. Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one. Unfortunately, our research shows problems with the way this medical decision is currently being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do not follow a standard process. The forms, pamphlets, websites, and videos used to help patients and families are biased and too difficult for most people to understand. Lastly, this is an emotional and even scary decision for most patients and their families, but the process does not help them deal with these feelings. Using feedback from patients, caregivers, clinicians, the study team made a paper and video decision aid to help people who are offered DT LVAD make this most difficult of decisions. Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers, is balanced, and is paired with training for doctors and nurses on how to best talk about DT LVAD. The investigators now propose to test the effectiveness and implementation of this intervention. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge, cluster-randomized, controlled trial across 6 medical centers. Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support intervention to improve patient and caregiver experiences. Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b: Post-implementation, patients and caregivers will have improved decision quality (greater knowledge and higher value-treatment concordance). Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision support intervention across multiple providers and settings. Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently; and maintained after trial completion.

COMPLETED
Ensuring Communication in Hospice by Oncology Study (ECHO)
Description

The goal of this study is to determine if scheduled communication with the oncology team through phone calls is helpful to caregivers with the transition to hospice care.

COMPLETED
Parenteral Hydration in Advanced Cancer Patients
Description

The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration. Objectives: 1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care. 1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care. 1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.

COMPLETED
Intervention to Improve Care at Life's End
Description

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site implementation study to evaluate a multi-component, education-based intervention to improve the quality of end-of-life care provided in VA Medical Centers.

COMPLETED
Methylphenidate for Depressed Cancer Patients Receiving Palliative Care
Description

The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.

COMPLETED
Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
Description

This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.

Conditions
COMPLETED
Hospice Problem Solving Intervention
Description

In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.

RECRUITING
A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
Description

This randomized clinical trial (RCT) intends to look at the preliminary efficacy of NOVELA (intervention group) in changing anxiety and self-efficacy compared to usual hospice care (control group). In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during twice weekly hospice telehealth visits to prepare caregivers for proper use of hospice support and healthcare services.

COMPLETED
Improving Self-Efficacy Through a Telenovela: Feasibility Study
Description

In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services

Conditions
ENROLLING_BY_INVITATION
Prospective Home-Based Palliative Care and Hospice Study
Description

The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone.

WITHDRAWN
Teaching Caregivers of Hospice Patients to Administer Reiki
Description

Being a family caregiver for a patient at the end of life is both rewarding and stressful. When the end of life is nearing, caregivers may be unsure of how to help their family member. Reiki, a light touch energy therapy has been shown to increase relaxation and improve sleep quality, and decrease pain, anxiety, depressive symptoms, and medication use in both hospitalized and community-dwelling adults. This feasibility study is designed to evaluate whether teaching caregivers is feasible in addition to evaluating any benefit to FCGs and patients.

ACTIVE_NOT_RECRUITING
Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers
Description

Background: Nature-based virtual reality (VR) and other outdoor experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.

COMPLETED
The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice
Description

Poor adherence to pain management and high pain intensity associated with serious, advanced illness is a major public health concern. This randomized clinical trial will test the efficacy of a newly enhanced digital pain and pain management application (e-PainSupport) for use in a home hospice setting. The e-PainSupport application delivers an education module about pain management to patients and caregivers, expedites pain reporting to nurses, and facilitates adherence to pain management. The overall goal of the e-PainSupport application is to improve pain management and reduce patient pain intensity in the home hospice setting.

Conditions
COMPLETED
Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.
Description

With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME), that focuses on assessing and addressing patient symptoms and caregiver burden in the home hospice setting through synchronous live video visits and educational videos. The aim of the first phase of the project is to employ an iterative user-centered design process to develop I-HoME for home hospice patients and their caregivers prior to implementation.

Conditions
RECRUITING
Embedded Palliative Care in the MICU
Description

The goal of this study is to investigate whether embedding a hospice and palliative care practitioner within a medical intensive care unit will improve patient outcomes and healthcare usage. The practitioner will work solely within the medical intensive care units and offer timely as well as proactive consultations based on clinical criteria and estimated mortality risk. The study team will compare patients seen by the practitioner to patients in an adjacent ICU and historical patients to determine whether patient care is improved by this intervention.