Treatment Trials

214 Clinical Trials for Various Conditions

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RECRUITING
Primary Care-based Study of an Online Workshop for Family Caregivers of PLWD
Description

Many family and friend caregivers of persons living with dementia experience depression, stress, and other adverse health consequences due to the responsibilities of their caregiving role. These caregivers express a desire for education and support. The overarching goal of this project is to improve education and support for caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia. Building Better Caregivers workshop is an online, 6-week, small group workshop for family caregivers of persons living with dementia that teaches them caregiving skills and how to manage difficult emotions, stress, and other challenging aspects of caregiving. Caregivers also receive support from other caregivers and two trained workshop facilitators and a workbook to keep. The workshop uses asynchronous delivery that allows caregivers to use materials at home when they have time day or night, self-pace their learning, and chat with other caregivers through threaded discussion board conversations. In this pilot embedded pragmatic clinical trial the investigators will evaluate the workshop among 108 caregivers who receive health care in urban areas of California and rural areas of New York. To achieve the project goals the investigators will (1) determine the feasibility of identifying, enrolling, and randomizing caregivers to a workshop group or wait-list group; (2) assess the feasibility of using electronic health record data as study outcomes, including depressive symptoms of caregivers and emergency room visits and hospitalizations of their patients with dementia; and (3) determine whether caregivers complete the workshop and think it is acceptable. If this pilot trial is successful, the investigators will have the information necessary to conduct a larger study among many additional caregivers with the long-term goal of improving their health and the well-being of their person with dementia.

NOT_YET_RECRUITING
Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery
Description

The goal of the trial is to test the usability, feasibility and acceptability of an unsupervised, appbased yoga program for participants undergoing thoracic RT and their caregivers.

RECRUITING
Designing a Dyad-Based MHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
Description

This clinical trial develops and tests a mobile health (mHealth) intervention to improve adherence to lifestyle recommendations in colorectal cancer (CRC) survivors and their family caregivers. The current challenge for cancer survivorship is identifying novel approaches to help adhere to the lifestyle recommendations that have been shown to improve symptom burden, health outcomes, and health-related quality of life (HRQoL). The development of a digital health intervention specifically for CRC survivors and family caregivers may improve adherence to the American Cancer Society Nutrition and Physical Activity Guideline for Cancer Survivors and improve family health.

RECRUITING
Family Caregiver Online Survey (Dementia and Swallowing Difficulties)
Description

The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).

NOT_YET_RECRUITING
Testing & Refinement of CarePair: An Assessment and Referral Platform to Support Family Caregivers of Alzheimer's Disease and Related Dementias.
Description

The purpose of this study is to develop and test CarePair, a mobile application-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being. The main aims of this study are: * To evaluate the feasibility and acceptability of the CarePair mobile application. * To explore the potential for CarePair to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy. Caregiver participants will be asked to log in and use the CarePair application and complete study activities for a six-week duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.

RECRUITING
Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers
Description

The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.

Conditions
RECRUITING
Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
Description

This study will compare the effectiveness of a web-based long-term care planning tool (Map Our Life) partnered with traditional case management services to traditional case management services partnered with an attention-control Centers for Disease Control and Prevention (CDC) sponsored website on health promotion for people with disabilities. The goal of this clinical trial is to promote long-term care (LTC) knowledge and planning among individuals with intellectual/developmental disabilities (IDD) and their family caregivers to improve social supports, health, and quality of life outcomes.

COMPLETED
Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers
Description

The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers. The main questions it aims to answer are: Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals Participants will have access to: One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs. The efficacy of the intervention also will be examined on key outcomes.

RECRUITING
A Nature-Based Virtual Reality (VR) Intervention in Family Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
Description

Background: People who receive an allogeneic hematopoietic stem cell transplant (HSCT) require long-term care at home afterwards. Their caregivers often experience high levels of stress, which can lead to symptoms such as depression, anxiety, poor sleep, fatigue, and difficulties with concentration and memory. Objective: To explore whether a nature-based immersive virtual reality (VR) program helps reduce stress in people who care for HSCT patients. Eligibility: People aged 18 and older who are primary caregivers of HSCT patients. Design: This is a two-phase study. Participants will be enrolled for 4 weeks. They will have 2 clinic visits. Participants will have a physical exam at the beginning of the study. They will be asked to provide a saliva sample in Phase 1, and saliva and blood samples in Phase 2. Participants will be given a VR headset. This is a device that looks like a pair of goggles worn over the eyes. They will be asked to wear the headset for 20 minutes per day. They will see 360 (Infinite) high-definition videos of nature and hear nature sounds. Participants will record the time they spend using the VR headset in a daily diary. They will take surveys with questions about any stress and symptoms they feel once a week. This will take up to 5 minutes. Participants will have a short regular follow-up visit by phone one week after starting their participation. At the end of the intervention study, participants will return for another physical exam. They will give saliva and/or blood samples again. Researchers will also look at the medical records of the HSCT patients; the HSCT patients must consent to this.

RECRUITING
Learning Skills Together Family Caregiver Complex Intervention
Description

Learning Skills Together (LST) is a 6-week psychoeducational intervention focused on complex care (nursing) tasks completed by family caregivers to persons living with Alzheimer's Disease and related dementias. This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by building caregiver self-efficacy. To do this, eligible participants will be randomized into an intervention group (LST) or a control group condition focused on healthy living for family caregivers. Participants will be asked to complete surveys before and after participating in the intervention or the control condition to determine whether change in hypothesized outcomes can be attributed to the intervention condition.

RECRUITING
Telehealth to Reduce Mental Health in Family Caregivers
Description

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.

RECRUITING
TACAD Program for Asian American Family Caregivers of Persons Living With Alzheimer's Disease
Description

The purpose of the proposed study is to preliminarily evaluate Technology-based information and coaching/support program that is tailored for Asian American midlife women who are family caregivers of patients living with Alzheimer's disease (TACAD) in improving health outcomes of Asian American midlife women who are family caregivers of persons living with Alzheimer's disease (AACA) and their care recipients.

SUSPENDED
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
Description

To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.

COMPLETED
Juntos/Together Program to Build Confidence for Complex Care Tasks Among Latino Family Caregivers
Description

The overall goal of this study is to culturally adapt and test the effectiveness of Learning Skills Together (LST) in improving self-efficacy among Latino family caregivers. To address this overall goal, the study team propose the following aims: i) culturally adapt the LST intervention for Latino caregivers using a community-engaged approach; and ii) examine the effect of the LST intervention on Latino caregiver self-efficacy, depression, and well-being using a randomized wait-list control group.

WITHDRAWN
Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
Description

The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.

Conditions
UNKNOWN
Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study
Description

In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.

RECRUITING
Supporting Family Caregivers of Persons With Dementia
Description

Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).

COMPLETED
Family Caregivers in Underserved Populations Providing Complex Cancer Care
Description

This clinical trial develops and tests a model of family caregiver education focused on the role of underserved family caregivers as providers of complex care in the home. Cancer patients have symptoms from their cancer or treatment and are then supported by family caregivers at home with tasks requiring technical skill. Family caregivers are often asked to provide complex care whether it involves decisions about managing symptoms or providing technical care for ports/pumps, tubes, or devices. Family caregivers often are not given enough information on how to provide care for patients at home needing complex care. The results from this study may help researchers refine and improve the intervention for caregivers through future research for caregivers on a much larger scale.

COMPLETED
Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit
Description

The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.

SUSPENDED
Improve the Patients' Recovery With Family- Caregivers to End Delirium
Description

This research is being done to find out if patients and caregivers who use the iPREPARED mobile health technology experience less delirium, a type of acute confusion, and if they do experience delirium, the delirium will be less severe and distressful. iPREPARED prepares patients and caregivers on what to expect during their hospital stay and provides instructions and resources on how to use non-pharmacologic strategies like re-orientation, distraction techniques, and other activities to maintain their brain health during their hospital stay.

Conditions
COMPLETED
Chinese American Family Caregiver Writing Study
Description

The Chinese American Family Caregiver Writing Study is a Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among Chinese Americans who are providing care for family members undergoing cancer treatment.

COMPLETED
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia
Description

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

COMPLETED
Exergame Study for Family Caregivers
Description

The goal of this study is to examine Go\&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

COMPLETED
Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study
Description

The goal of this project is to pilot test CHEC (Collaborative Healthcare Encounters with Caregivers) in primary care. CHEC is brief intervention with two components: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older patients (aged 65+) to their primary care visits and 2) accompanying Tip Sheet for clinicians.

COMPLETED
Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers
Description

Persons with Alzheimer's disease and related dementias (ADRD) experience behavioral symptoms such as agitation, combativeness, depression, and apathy. These behaviors increase caregiver stress, which leads to negative outcomes, such as poor health, depression, and increased caregiver burden. This project seeks to develop and test an intervention to enhance active caregiver skill training to prepare caregivers to better manage behavioral symptoms in order to improve ADRD caregiver wellbeing. This intervention is called Enhancing Active Caregiver Training (EnACT). The study team will develop and conduct initial testing of EnACT techniques in a small group intervention with family caregivers of persons living with dementia. This intervention will first develop and refine EnACT through small group meetings with ADRD caregivers. Next, EnACT will be tested by two groups of ADRD caregivers in order to assess how achievable and useful caregivers find it to be. In addition, EnACT will be evaluated for its impact on caregiver preparation, stress process, and well-being.

RECRUITING
Dementia Family Caregiver Study
Description

The proposed study will test a 3-month, community health worker (CHW) delivered home visit, culturally and language-appropriate intervention for ethnic and underserved dementia family caregivers of persons with dementia (PWD) using wearable technology for real time monitoring of caregivers' stress and sleep. The CHW delivered home visit intervention includes stress reduction techniques by mindful deep breathing and compassionate support/listening and caregiving education to improve caregiver's health, wellbeing, and positive interactions with the PWD. This dementia caregiver study using wearable technology has the potential to significantly lessen health disparities in dementia care, assisting underserved ethnic dementia caregivers in self-management and increasing their quality of life.

RECRUITING
Persons With Dementia and Their Extended Family Caregivers
Description

Immediate family members shoulder the majority of care responsibilities for persons living with dementia. However, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin. The main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. We aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. We will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers. We will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. Our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). This study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.

COMPLETED
Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
Description

The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.

RECRUITING
Decision Support Training for Advanced Cancer Family Caregivers: the CASCADE Factorial Trial
Description

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 256 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

COMPLETED
GamePlan4Care: Online Support for Family Caregivers
Description

As the population of older adults grows, almost doubling in size from 2012 to 2040, so too will the need for family caregiving. Caregiving can lead to negative psychosocial outcomes such as depression, anxiety, and burden; social isolation and family conflict: financial strain due to costs of care; and some caregivers also experience negative health consequences. This project will test the value of GamePlan4Care (GP4C) an evidence-based, internet-enabled system capable of providing immediate, tailored education and skills training to caregivers who can access live support from a DCS via phone or web-based video.

Conditions