Clinical Research Directory

Recovery Inspired Support Engagement (RISE) Pilot

The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are: How many people complete the program? How satisfied are people with the program? Participants will: Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (\~week 6), at the end of the program (\~week 12), and 12-weeks after the end of the program Complete a focus group or interview

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

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.

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.

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

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.

The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Feasibility and Acceptability of Earkick for Family Caregivers: Evaluation Study

This study evaluates the feasibility and acceptability of using the artificial intelligence (AI) chatbot mobile application (called Earkick) to support the well-being of informal care partners of individuals with traumatic brain injury (TBI), dementia, or Huntington disease (HD). Over an 8-week intervention period, up to 60 care partners will engage with the application (app), spending four weeks focusing on physical health and four weeks focusing on mental health. Participants will complete surveys at the midpoint and end of the intervention period. Participants will also complete a semi-structured interview to discuss participants experience using the Earkick app. The study team hypothesizes that care partners will find the chatbot acceptable and feasible to use in daily life, and that there will be low attrition and high completion rates of the study.

Virtual Reality-Based Mindfulness for Caregivers of Psychiatric Patients

This clinical investigation aims to compare the mental health status of caregivers of psychiatric patients before and after virtual reality-based mindfulness. The study's primary objectives are to: 1. Does immersive audio-based mindfulness have a greater positive impact on psychological well-being than virtual reality-mediated mindfulness? 2. When compared to a single session, do four sessions lead to more improvements in psychological well-being? To assess the additional impact of virtual reality-mediated mindfulness, participants in the control group will receive mindfulness via immersive audio. Those who voluntarily sign up for the study will participate in four sessions, one each week, on the same day and at the same time. Prior to and following the mindfulness intervention, self-administered psychometric assessment batteries will be completed. While the control group will use ears to complete the mindfulness session using immersive audio, the experimental group will get a virtual reality-mediated mindfulness intervention. BECOME is the company that provides the audio and video content.

WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME

The goal of this clinical trial is to learn whether an evidence-based caregiver support program (Hospital GamePlan4Care) can benefit caregivers of hospitalized Veterans with Alzheimer's Disease and Related Dementia who are discharged to skilled nursing facilities prior to returning home. The main questions it aims to answer are: * Is Hospital GamePlan4Care feasible and acceptable to caregivers? * Does Hospital GamePlan4Care improve caregiver-reported outcomes? Researchers will compare Hospital GamePlan4Care to health education to see if it improves caregiver reported outcomes. Participants in the Hospital GamePlan4Care arm will receive tailored skills training and support. Participants will be asked to: * Complete tailored skills training on the Hospital GamePlan4Care website * Complete four phone calls with a dementia care specialist to receive tailored training and support * Complete questionnaires at enrollment, one month, and three months after enrollment. * Complete an interview at three months Participants in the health education arm will receive education materials for caregivers. Participants will be asked to: * Review the education materials * Complete four phone calls with a dementia care specialist to review the materials * Complete questionnaires at enrollment, one month, and three months after enrollment.

The WeACT Program for Family Caregivers of People Living With Dementia

The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most. The main questions this study aims to answer are: * Can caregivers complete WeACT as planned? * Do caregivers show improvements in mental health and coping after using WeACT? * What are caregivers' experiences with the program, and what suggestions do they have to improve it? Participants will: * Complete six self-paced weekly online modules and use the daily practice section during the program. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experience.

Pilot Study of Hospital GamePlan4Care

Hospital stays are stressful for the family and friends who care for adults with dementia. Following hospital discharge, adults with dementia often have increased care needs, which places new caregiving demands on their family and friends. Family and friends are critical to ensuring that Veterans with dementia can live safely in the community following discharge. Healthcare systems have an opportunity to support family and friends of adults with dementia by addressing dementia-specific caregiving challenges that arise during the transition from hospital to home. The investigators are comparing two different support programs for family and friends of hospitalized adults with dementia. The two programs are Hospital GamePlan4Care and Caregiver Education. Hospital GamePlan4Care was developed with feedback from people who care for Veterans with dementia. Hospital GamePlan4Care helps caregivers build skills to care for someone with dementia recently discharged from the hospital. It includes a written handbook, online training on the Hospital GamePlan4Care website, and phone calls with a dementia care specialist. The online training is tailored to the caregiver. The Caregiver Education program provides information that helps caregivers care for someone recently hospitalized. It includes a written handbook, recommendations for high-quality online resources, and phone calls with a dementia care specialist. Both programs will start when the adult with dementia is hospitalized. Each program lasts at least three months. To be eligible, the caregiver must care for a Veteran with dementia admitted to the Michael E. DeBakey VA Medical Center in Houston, Texas. Caregivers interested in participating and passing eligibility screening will be enrolled in the study for at least three months. Each enrolled caregiver will have a 50% chance of being enrolled in the Hospital GamePlan4Care group or the Caregiver Education group (like flipping a coin). Both groups will be asked to complete several questionnaires about their needs as a caregiver and their well-being. Questionnaires will be completed at the beginning of the study and one and three months after the Veteran is discharged from the hospital. Each questionnaire should take 30-60 minutes to complete.

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

A Multi-center Investigation of Family Health.

The current healthcare system is unable to identify burdened and vulnerable families affected by cancer, partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship. Recent reviews have documented a general lack of cancer studies including both the patient and the family, and a particular deficiency in studies including more than the spouse. The principal aim of this study is to investigate family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience in both patients with cancer and their families across the cancer trajectory. Additionally, the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability.

Effect of a Person-Centred Care Intervention for Families Providing Home-Based Care to a Person With Advanced Chronic Illness: A Pilot Randomised Controlled Trial

The goal of this clinical trial is to learn if a Person-Centred Care (PCC) intervention can improve the caregiving experience and wellbeing of families who provide home care for a loved one with advanced chronic illness. The main questions it aims to answer are: * Does the PCC intervention improve families' caregiving experience, preparedness for caregiving, and psychological wellbeing? * Is the PCC intervention feasible and acceptable for implementation in primary care settings? Researchers will compare families who receive the PCC intervention in addition to usual care to families who receive usual care alone. Participants will: * Take part in an initial in-person consultation with a primary care nurse to share their family caregiving experience and co-create a personalized health plan. * Have monthly follow-up contacts with the same nurse over a 3-month period to update and adapt the plan. * Receive a copy of the updated plan after each contact to guide caregiving and support decision-making.

Young Children and Screens: Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age

The overall aim of the research project is to investigate screen habits among children (0-5 years) and their parents including nurses' perspective, and further parents' and nurses' experiences of using web-based healthcare advisory services within Swedish child health care (CHC). The main research questions are: What is the correlation between children's and their parents' screen use? How does screen use differ among families with various socioeconomic backgrounds? How well does the modified SCREEN-Q instrument measure screen use in Swedish conditions? How do parents perceive their own and their children's screen use and their parental role? What are parents' views on available advice and recommendations regarding children's screen use? How do parents use and experience web-based advisory services within health care and Swedish child health care (CHC)? How do CHC nurses address screen media-related issues within CHC? What are CHC nurses' experiences with web-based advisory services? Participants will: * Complete a survey on screen habits and digital health service use (N ≈ 300) * Contribute to validation of a modified SCREEN-Q instrument * Take part in interviews (parents) and focus groups (child health nurses)

MUSic Listening Impact on QUality of Life, Brain and Burnout of ALzheimer' Patients Informal Caregivers

Although life expectancy is increasing, the risk of dependence and/or loss of autonomy is increasing too with ageing. Alzheimer's disease affects many people and this kind of disease is constantly growing. Today, relatives of these sick people are increasingly taking on the role of carer to help them remain at home as long as possible. This situation of assistance has often a negative impact on the quality of life of the caregiver, which in some cases can lead to the caregiver burnout and increase the risk factors for developing pathological ageing. This situation can also damage the relationship and the quality of interactions between patient/caregiver dyad. Non-pharmacological therapies and the use of digital tools appear to be promising avenues to fight psychological distress and social isolation, but also to improve the quality and duration of homecare services, by promoting the autonomy of the patient. The MUSIQUAL+ study aims to evaluate the impact of music listening offered to caregivers, alone or with their sick relative, on the quality of life and the exhaustion felt by the caregiver. Three times 20-minute sessions a week of music listening at home through the use of a tablet application, for 12 weeks, will be proposed. In addition to the collection of subjective feelings of the caregivers, a neuropsychological evaluation of the patient and the caregiver will be carried out on 90 dyads divided. Finally, in order to better understand the cerebral mechanisms involved and to provide evidence of the effect of this intervention, an EEG recording will be made before and after the musical listening. This study proposes a therapeutic and preventive alternative to drug treatments and to the currently unsatisfactory support of patients and their caregivers in distress; its benefits will be assessed too.

Predictive Factors for Initial MMSE Score and Rapid Decline in Alzheimer's Disease Patients

This study looks at people with Alzheimer's disease to find out which factors are linked to their initial score on the Mini-Mental State Examination (MMSE) and which factors may predict a fast decline in their score over 12 months. Researchers will review medical records from patients seen at the Memory Clinic of Gonesse Hospital and analyze information such as age, education, medical history, nutrition, mood, and caregiver burden. The goal is to better understand what influences early cognitive performance and how quickly it changes, to help improve patient care and planning.

Psychoeducation for AlloHCT Caregivers

Background: Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for hematological malignancies face significant challenges that can impact their well-being. This study aims to evaluate the feasibility and acceptability of an adapted psychoeducational intervention(PEI) designed to support these caregivers. Methods: This study will recruit caregivers of alloHCT patients. Participants will be enrolled during pre-transplant clinic visits, typically 2-4 weeks before the scheduled transplant. The intervention consists of eight sessions over 12 weeks, delivered via Microsoft Teams by a nurse facilitator. In the adapted PEI, participants will learn stress management, coping strategies, energy management, goal-setting, communication skills, and support resource access through interactive exercises. Data Collection: Participants will complete questionnaires at three time points: pre-intervention, one month post-transplant, and three months post-transplant. The final assessment will include additional questions about feasibility, acceptability and the initial efficacy of the adapted PEI. Outcomes: The primary outcomes will be the feasibility and acceptability of the adapted psychoeducational intervention (PEI). Secondary outcomes will include initial efficacy of the adapted PEI on caregiver outcomes such as depression, anxiety, satisfaction with caregiving and quality of life. Significance: This research aims to assess the feasibility, acceptability and initial efficacy of implementing the adapted PEI for alloHCT caregivers. If found feasible and acceptable, this intervention could potentially improve caregivers' ability to manage caregiving stressors and pave the way for larger-scale randomized studies and implementation.

Cereset Research for Caregivers

Caregivers experience high levels of prolonged stress that can lead to chronic problems with health, including increased risk of cardiovascular disease that is linked to autonomic dysregulation. Heart rate variability (HRV), measures of autonomic cardiovascular regulation, is decreased (worse) in caregivers. Autonomic function is linked to lateralization in the brain, and emerging neuromodulation methods that target lateralized signals in the brain, like Cereset (CR), may be able to improve heart rate variability. Therefore, this pilot study aims to test whether CR can improve HRV in caregivers of a person living with dementia experiencing stress, anxiety, or insomnia, as well as improve self-report measures of stress, sleep and caregiver burden.

Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation

This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.

Implementation of the Caregivers-Patients Support Coping with Advanced-Cancer (CASA) Intervention.

This pre-pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.

New Rear Anti-tip Device for Manual Wheelchairs: Subjective Input (RAD-SI)

The objective of this study is to obtain subjective input from wheelchair service providers and end-users about their experiences with conventional rear anti-tip devices (C-RADs) of manual wheelchairs and the potential usefulness of a new design.

Survey for Caregivers Aged 50 and Over

There are more and more informal caregivers (PPA) in Quebec. Their increase between 2012 and 2018, according to data from the "General Social Survey - Care Given and Received," was significant, around 32%. The available data paint a typical portrait of a Quebec caregiver: (a) she is a woman, (b) aged between 50-55 years, (c) who devotes at least 3 hours of her time per week, on a regular basis, (d) to caring for an elderly parent. To this date, there is no reliable data on the health status-whether mental, physical, or social-of caregivers in Quebec. Yet this information is crucial because it affects the ability of caregivers to fulfill their role and, consequently, the stable health of the individuals they care for, allowing them to continue living at home. This situation exposes caregivers to a decline in their own health, and by extension, the health of those they care for. The fact that the typical Quebec caregiver is 50 years old or older increases the risk of health deterioration within the caregiver-care receiver pair. Indeed, age 50 is when the effects of physiological and pathological aging begin to impact the physical capacities of the elderly. Developing new practices that focus on the health characteristics of both caregivers and care receivers, in order to prevent health deterioration, is therefore a crucial step in supporting caregivers in their role and ensuring that care receivers can stay at home in good conditions for as long as possible. The issue of caregivers' health is still under-addressed in Quebec, both in the scientific literature and in population surveys. It seems that caregivers need a comprehensive evaluation of their health status (physical, mental, and social), given the significant impact caregiving has on their health. Research conducted within the Living Lab, led by Dr. Beauchet's team, has helped develop tools and questionnaires that effectively assess the frailty of individuals aged 50 and over and produce reports that raise awareness about their health status, enabling them to implement future care solutions that meet their needs. The overall objective is to assess the health status (mental, physical, social) of caregivers aged 50 and over, living in Quebec-through self-assessment to make them aware of their actual health condition and engage them in a process of self-care.

The Impact of Chatbot-Assisted Nursing Education on Perceived Burden of Care and Caregiver Stress

Caregivers play a key role in the provision of day-to-day care and the coordination of care services. Caregivers of stroke patients use dysfunctional coping strategies to cope with the stressors and burden of care they encounter during this long caregiving process. In this study, it will be tried to improve the stress coping skills of caregivers by using an application with chatbot support based on the COM-B model.In the study, introductory information form, stress coping styles scale, depression, anxiety, stress (DASS 21) and burden of care measurement tool will be used. The study will be conducted in a randomized controlled manner. Chatbot will be applied to the experimental group and the control group will be exposed to routine practice. The study group will consist of individuals who care for those who are discharged home from Atatürk University stroke center. Experiments and controls will be accessed by searching the hospital records. The fact that nursing education is given through a chatbot and that the chatbot is designed according to a stress training model (behavior change wheel) reflects the originality of the study. With this study, caregivers are expected to be able to manage stress effectively by teaching them how to cope with stress.