116 Clinical Trials for Various Conditions
This study will test the psychoeducation course, Caregiving while Black - Learning In Vital Engagement (LIVE), among Black caregivers providing care to persons with dementia. This course aims to enhance Black caregivers' capacity to cope effectively with their caregiving role of navigating care and the world of healthcare in ways that take into consideration the social and cultural context of their unique life experiences.
This study is a longitudinal, randomized-controlled study with a stepped-wedge research design. The Integrated Early Childhood Development Activity (IECD) will implement interventions in three cohorts of villages sequentially across two provinces of Cambodia, Kampong Thom and Preah Vihear. IECD will collect data from all three cohorts together, four times, at 12-month intervals: a baseline prior to any program intervention, a Cohort 1 end line, a Cohort 2 end line and a Cohort 3 end line. IECD's Theory of Change is that by changing caregivers' practices in rearing their children under age 5, those children will demonstrate improvements in child development outcomes. The investigators will use 6 instruments to collect this data, including well-established internationally validated measures. The IECD team enrolled 1,790 households in Preah Vihear and Kampong Thom in June and July 2021. The study will be competed in 2025.
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.
Two arm study, experimental and control, to explore the impact of an online training program to prepare community health workers (CHWs) conduct effective outreach to support African American and Latino male caregivers of older adults.
The goal of this project is to revise and test an online education program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness. This study has two phases, and participants will take part in Phase 1 and/or Phase 2 of this study. Participants will take part in one and/or both phases in this study if they are a caregiver to a person living with dementia. Caregivers must self-identify as Black American and as the unpaid principal caregiver of a community-dwelling person living with a dementia illness and who is the principal companion of that person during healthcare encounters. Caregivers must also be 18 years of age or older and will be providing at least some hands-on care multiple times a week, if not daily. It is preferred that participants have access to and the ability to use broadband internet services to engage with the Caregiving While Black course. Participants should not have a plan in place to move the person living with a dementia illness to an institutional setting within the next six months.
Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with 30 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
Family caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. It is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
Background: In the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects. Objective: To learn how the caregiving process affects the health and well-being of caregivers over time. Eligibility: Adults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities. Design: Participants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years. Participants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support. Participants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life. Participants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving. Participants may give a blood sample each year they are in the study. ...
This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.
This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months.
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
The overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Participants will be asked a series of questions in a baseline interview, and then will be asked to partake in the CaRE course during a 6 to 8-week period.
The purpose of the Daily Study of Caregiving Relationships and Health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. This is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.
The goal of this study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the specific needs of LGBT caregivers of PLWD.
The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.
The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN on reducing informal caregiver burden at 6 months, and 3) To estimate the effect size of BCN on reducing patient behavioral and psychological symptoms of dementia (BPSD) at 6 months. Subjects will be recruited from the Aging Brain Care (ABC) program of Eskenazi Health and Indiana University Health located in central Indiana.
Background: Cancer causes changes in the lives of patients and in the lives of their caregivers. Patients and caregivers feel stress and they affect each other as they deal with these changes. They each cope with cancer diagnosis and treatment on their own. They also cope together. Researchers want to explore this shared change of roles and responsibilities. They will do this by gaining insight into the social experience of cancer caregiving. They also want to better understand the ways caregiver/patient teams manage the cancer diagnosis and experience. This can help find new ways to support caregivers and their patients. Objective: To explore the shared change of roles and responsibilities of patients and caregivers by studying the social experience of cancer caregiving. Eligibility: English speakers ages 18 and older who are one of the following: A cancer patients at the NIH Clinical Center (CC) A caregiver of a CC cancer patient Design: Participants will have been screened by the CC. Patients and caregivers will be interviewed separately. This will last up to an hour and a half. Participants will complete online surveys. Participants may have a follow-up phone interview. This will last up to 15 minutes.
This screening tool will be used to identify significant relations of patients with advanced medical illness or serious hospitalization and family individuals who lost their loved one and who could use professional support in the future. We are interested in enrolling family members or close friends of patients with advanced medical illness as well as family members or close friends who have lost a loved one. Some screening tools to identify family members who might need support do exist, but the investigators are hoping to develop one that is brief and easier for healthcare providers to use. The information learned in this study will help us refine the screening tool. Family member input will be essential in the development of this screening tool.
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach Veterans how to safely, skillfully, and (when possible) independently perform Activities of Daily Living involving transfers. Experts (OTs) who provide this training will also recommend, provide, and install assistive technology devices such as grab bars, bed rails, and toileting aids as needed. Research assistants conduct home visits with the dyads pre and post intervention to determine the effects of the program on Veteran and caregiver quality of life measures (burden, depression, task efficacy, lifespace). Half of the couples in this study will receive the training from the expert remotely through a tele-video conferencing device. Research assistants will bring the device to participants' homes and assist in the training session.
The purpose of this study is to provide a communication training program to inpatient nurses and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist caregiving families. The importance of this training program is that it aims to teach nurses and social workers how and when to respond more effectively and compassionately to challenges faced by caregiving families. One of the goals of this program is to address family support needs during a patient's hospitalization.
This study compares the medical and psychological effects of telemonitoring plus intensified self-management support to those of usual care alone for patients with poorly controlled type 2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or clinician burden, then its implementation could yield major public health benefits, especially for vulnerable and underserved DM patients, and broader societal benefit may occur through increased helping behavior and strengthened social ties.
Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care. This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use.
Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged. These caregivers experience significant distress associated with caregiving, which may be particularly salient in the context of inherited conditions. Previous studies have not examined caregiving from a network perspective, nor have they considered how cognitive and emotional responses, such as caregivers worry for themselves and relatives acquiring the disease or guilt related to the genetic etiology of their child s illness, as possible stressors; the current project fills this literature gap. Caregiving processes may vary across type of illness and the life course. In illnesses that impact children, parents and grandparents may take on caregiving roles whereas in conditions that impact adults, spouses and adult children may provide care. Caregivers must adapt to the strain of caring for their affected relatives and this adaptation may differ depending on caregiver roles. The caregiver s support network may influence adaptation, impacting the health and well-being of patients, their caregivers, and other relatives. This project, comprised of 5 substudies, will examine social contexts surrounding families involved in caring for individuals with chronic inherited conditions from a relational perspective. Surveys and interviews will assess participants cognitions and emotions about the disease, caregiving burden and caregiving/support network systems. In addition, biomarkers will be considered in 2 substudies to examine how caregiving roles and expectations impact health among caregivers. As part of our current inquiry, we have developed an assessment tool aimed at understanding caregiver experiences related to dietary practices in the context of metabolic conditions. To evaluate the psychometric properties of this scale, we propose a fifth substudy under the current protocol. We aim to recruit at least 5550 participants through residential/daycare centers, advocacy groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological and non-biological adult relatives of affected individuals and typically developing controls to construct and evaluate caregiving/support network systems. This project will use a social network framework to develop and adapt common measures of caregiving roles to evaluate burden, perceptual bias, and unmet expectations in caregiving. The psychometric properties of these new measures, characteristics of family caregiving and support networks, and how these network characteristics are associated with caregiving strain and well-being, including biomarkers of physical health, will be investigated. The moderating role of family members cognitions and emotions and disease context will be considered. Findings will guide future research to develop network-based interventions promoting positive adaptation to the presence of inherited conditions in families through improved social environments and coping skills....
The specific aims of this study are to: 1. Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the intervention group will report less upset with target behaviors at 4-months in comparison to caregivers in the control group. 2. Test the immediate effectiveness of the intervention to reduce caregiver burden (secondary outcome). Hypothesis: Caregivers in the intervention group will report less burden at 4-months in comparison to caregivers in the control group. 3. Test the immediate effectiveness of the intervention to reduce the frequency of occurrence of targeted disruptive behaviors in persons with dementia (secondary outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in the control group. 4. Test the maintenance effect of intervention at 6-months on caregiver upset and burden and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in intervention will maintain reduced upset and burden and report less occurrences of targeted behaviors from 4 to 6-months. 5. Assess the cost of the intervention and its cost effectiveness. We have also received funding to conduct a supplementary study to evaluate the effect of the nurse intervention on behavior reduction and caregiver distress. The specific aims of this supplementary study arm are to: 1) describe the prevalence and type of medical conditions among control group participants who receive the nurse intervention, 2) describe for those with a detected medical condition/problem, the number of caregivers who follow-up with physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether control group participants who receive the nurse intervention report reduced disruptive behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for control group participants who receive the nurse intervention, compare the level of disruptive behaviors and caregiver upset 4 months from entry into this study arm with the results in the Project ACT experimental group (who received the multi-component intervention).
Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a unique, multi-site research program sponsored by the National Institute on Aging (NIA) and the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature.
The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are: * How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? * What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after.
Most stroke survivors return home, where their care is supported by family and friends. Although family caring at home is usually rewarding, it is often challenging, too. The demands and responsibilities of caring for a loved one at home can be stressful. The actual activities of caregiving vary according to the needs of the stroke survivor, but can include helping with bathing, dressing, eating, and many other activities. Caregivers must learn care techniques and how to manage changes in roles and lifestyle. While adjusting to these changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance or support for doing this. In this study, we are testing a self-care intervention for older, spouse caregivers of persons with stroke to see how helpful the intervention is in reducing distress and in helping caregivers adopt and maintain healthy lifestyle behaviors. We have developed an intervention for caregivers that is called Self-Care TALK. The intervention includes creating a health-promoting, self-care education and support partnership between caregivers and nurses through the use of weekly telephone conversations. Each conversation focuses on a health-related topic, such as: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. The conversations follow a basic format, but also are unique to each person. Participants complete questionnaires before and after the intervention, so that we can test the effect of participation in Self-Care TALK on caregiver health. We know that education and support about self-care can be achieved through partnerships between family caregivers and health care professionals. Our goal is to build on this knowledge in testing whether participation in the Self-Care TALK intervention will result in less distress and better health and well-being for spouse caregivers, compared to caregivers who receive no additional care beyond usual education and support. In working toward this goal, we are using a partnership approach, in which nurses and caregivers discuss several health-related topics and mutually identify creative solutions for caregivers to incorporate self-care and health-promotion strategies into their daily routines. Promoting healthy outcomes for caregivers is essential to supporting their personal well-being, and to fostering their ability to continue home care for their loved one.