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Showing 1-20 of 136 trials
NCT06821230
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.
NCT07461168
Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study. Participants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.
NCT07279103
This study aims to examine the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive status, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches in Alzheimer's management have been shown to slow functional decline, reduce behavioral symptoms, and improve caregivers' well-being. Multisensory environments provide visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory stimuli to support sensory integration and enhance engagement, particularly in individuals with cognitive and communication difficulties. The study will be conducted using a randomized controlled design and will include individuals aged 65 years and older with moderate-stage Alzheimer's disease and their primary caregivers. The intervention will be implemented over four weeks with two sessions per week. Outcome measures will include the Adult/Adolescent Sensory Profile,Loewenstein Occupational Therapy Cognitive Assessment-Geriatric version, Neuropsychiatric Inventory, and Zarit Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.
NCT07452419
While previous Egyptian studies concerned to the quality of life of cancer patient, up till few available studies include their caregiver and we appreciate their role and efforts in cancer patient wellbeing so we are trying to explore some points of quality of their life. Aim of the study: The aim of this study was to evaluate the factors influencing the Quality of life of caregivers of cancer patients. Identifying, outlining, and integrating the factors associated with cancer patients' caregivers' burden and Quality of life will be critical for policy formulation to mitigate those factors and improve the lives of both patients and caregivers. These insights are expected to be useful in determining the optimal timing for caregiver interventions in the future. Objectives: To assess the quality of life of PCs of patients with cancer attending Sohag University Hospital and sohag oncology institute. To detect factors that impact PCs' QOL attending Sohag University Hospital and sohag oncology institute.
NCT07434440
This randomized controlled trial aimed to examine the effect of a nurse-led psychoeducation programme on self-efficacy and psychological resilience among caregivers of patients receiving home health care. Caregivers were randomly assigned to either an intervention group receiving a structured psychoeducation programme or a control group receiving usual care. Outcomes were assessed at baseline and one week after completion of the intervention using validated measurement tools.
NCT07168577
Cerebral palsy (CP) is a lifelong condition that affects movement and posture in children, often requiring continuous care from family members. Children with CP frequently experience sleep problems due to spasticity, pain, seizures, or behavioral difficulties. Poor sleep can negatively affect the child's health and development, as well as increase the physical and emotional burden on their caregivers. This study aims to evaluate the sleep quality of children with CP and their primary caregivers, and to examine the relationship between caregiver burden and these sleep-related factors. The study will include children aged 2 to 18 years with a diagnosis of CP and their primary caregivers (parents or legal guardians). Children's sleep patterns will be assessed using the Children's Sleep Habits Questionnaire (CSHQ). Their functional levels will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Caregivers' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS). By identifying how sleep problems are linked with caregiver burden and psychological health, this study may provide valuable insights for developing supportive intervention programs for both children with CP and their families.
NCT06276023
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
NCT05336344
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).
NCT07387562
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.
NCT07322081
This study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Caregivers of individuals with chronic mental health conditions are exposed to prolonged psychological, emotional, and cognitive demands, which may negatively affect their mental well-being and coping capacities. The study adopts a mixed-methods approach using an exploratory sequential design in order to obtain a comprehensive understanding of caregivers' needs and experiences and to evaluate the potential impact of the intervention. Qualitative findings are intended to inform the development and structuring of the MBSR program, while the quantitative phase is designed to examine changes in key psychological outcomes following the intervention. The study aims to contribute to the growing body of evidence supporting mindfulness-based interventions for caregiver populations and to inform future mental health service practices.
NCT07347639
In this study, we tested whether a support program could help people living at home with dementia keep making their own everyday choices for as long as possible, with help from a family caregiver and a home-care nurse. Nurses received training and coaching to better focus on what the person still wants and can do, and to avoid taking over tasks too quickly. The program also included home conversations with the person with dementia and their caregiver to agree on what matters most and how to support that in daily life. In total, 12 people with dementia, 14 caregivers, and 33 nurses took part. Most participants felt the program was helpful and said it increased attention to personal choice and small day-to-day decisions. However, it also took time and was sometimes hard to schedule, and some people dropped out. The questionnaires did not show clear improvements in things like quality of life, but there were signs that some behavior problems (such as restlessness or difficult situations) became less frequent for some participants.
NCT07342569
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.
NCT07329868
The goal of this clinical trial is to compare the effectiveness of cognitive-behavioral stress management (CBSM) and acceptance and commitment therapy (ACT) on the fear of recurrence, quality of life, psychological distress, and fatigue of caregivers of cancer patients. Researchers compare the effectiveness of CBSM and ACT to a Control(without receiving intervention) to see if treatment works to improve the health of caregivers of cancer patients. A comparison between the two treatments was also conducted to determine if there was a difference in their effectiveness. Participants: In this study, 66 participants were randomly assigned to one of three groups: the CBSM group, the ACT group, or the control group. The CBSM and ACT groups each attended eight 90-minute, in-person sessions twice a week.
NCT07308301
Primary Aim The primary aim of this study is to determine the quality of life and caregiving burden levels of caregivers of pediatric oncology patients and to examine the relationship between these two variables. Secondary Aims To evaluate the differences between caregivers' sociodemographic characteristics (age, gender, education level, marital status, income level, etc.) and their quality of life. To examine the differences between caregivers' sociodemographic characteristics and their caregiving burden levels. To determine whether caregivers' quality of life and caregiving burden differ according to the diagnosis and treatment characteristics of pediatric oncology patients (duration of diagnosis, type of treatment, frequency of hospitalization, etc.). Significance of the Study Childhood cancer is a process that deeply affects not only the patient but also the family, particularly the caregivers. Family members who provide care for children often face intense physical, psychological, social, and economic burdens. These challenges reduce caregivers' quality of life and increase their caregiving burden. Identifying the relationship between the quality of life and caregiving burden among caregivers of pediatric oncology patients is highly important in planning support services for families during the care process and in strengthening family-centered care practices by healthcare professionals. The findings of this study will contribute to the development of family-centered approaches in nursing care, the design of psychosocial support programs, and a better understanding of caregivers' needs.
NCT07276230
The diagnosis and treatment of multiple myeloma affect not only the patient but also their family and caregivers. Advances in therapy have transformed the follow-up of patients treated for multiple myeloma. The involvement of informal caregivers has become increasingly essential to ensure adequate home-based care, as most treatments are now delivered on an outpatient basis. Literature reviews suggest that caregivers of cancer patients often face unmet supportive care needs, which in turn negatively impact their quality of life.
NCT07035067
Filling the gap in Canadian evidence on the burden of PROC on QoL is essential. It will help better understand the impact of PROC on multiple aspects of the lives of patients and their caregivers and the real-life hurdles faced by PROC patients and their caregivers. The outputs of this study will help better understand the hurdles and challenges they face and the significant unmet medical need.
NCT05465109
The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy.
NCT06583018
Over 80% of caregivers for individuals with neurodegenerative diseases (ND) engage in significant risk behaviors, particularly physical inactivity, which increases the risk of cardiometabolic diseases (CMD) by 30% and reduces life expectancy by 4-8 years. Despite the health benefits of maintaining healthy behaviors, awareness of behavioral risk management among healthcare professionals and the public is low, and research on this topic for ND caregivers is limited. Given that physical activity (PA) is the most prevalent modifiable risk factor, timely intervention is essential. International guidelines prioritize PA as a key strategy for caregiver health. However, existing PA interventions often struggle with low compliance due to the physical and emotional challenges caregivers face. Our research group actively explores the health-regulating and enhancing effects of integrative mind-body modalities, particularly mindfulness, which may promote and sustain healthy behaviors by improving attentional regulation and psychological flexibility. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA. The World Health Organization advocates for non-communicable disease (NCD) prevention through brief lifestyle interventions, such as ecological momentary interventions (EMI), which use mobile messaging (e.g., WhatsApp) to deliver personalized health content. This method is particularly valuable for caregivers who find it difficult to access traditional services due to their responsibilities. This pilot randomized clinical trial aims to evaluate the feasibility and acceptability of an EMI-enhanced "Brief and Blended Mindfulness-based Lifestyle Counselling Programme" (B-Mindful-Life) compared to brief lifestyle education for increasing PA among Chinese ND caregivers. The primary outcome will be the feasibility (rates of recruitment, eligibility, refusal, and retention at 2 and 5 months), and acceptability measures (adherence, incidence of adverse events, and satisfaction with intervention).
NCT05970471
To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.
NCT07225179
The purpose of this study is to pilot the delivery of an mHealth intervention for caregivers to young people with early psychosis within a network of early psychosis intervention programs in the state of North Carolina. The investigators will examine the feasibility of recruitment through program outreach, develop North Carolina specific outreach resources to be used with the mHealth intervention and evaluate the effectiveness of this intervention for reducing caregiver psychological morbidity and improving family communication. The investigators will also collect pilot data to inform recruitment and development of implementation strategies for delivering Bolster within a statewide early psychosis network.