Clinical Research Directory

mHealth for Early Psychosis Caregivers in Statewide Program Outreach

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.

Music for Pain and Dementia

This study aims to provide mechanistic insights into how group drumming as a music-based intervention (MBI) affects pain responses and nociceptive function in individuals with Alzheimer's Disease (AD), mild dementia or mild cognitive impairment (MCI). Heart rate (HR), heart rate variability (HRV), and brain activity will be measured during communal drumming with their dyadic partners and others. Brain activity, blood pressure, cognitive abilities, blood hormone levels, and static and dynamic pain will also be measured during sessions pre and post the 8-week community drum circle. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), quantitative sensory testing (QST), behavioral, surveys, and physiological monitoring to study the impact of group drumming on pain and brain activity in AD and inter-dyad synchrony.

Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content (PancreasPlus).

Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. However, this active involvement can be difficult if there is poor communication with healthcare teams, differences in skills or familiarity with digital tools, or systems that do not support patient participation. The PancreasPlus app was developed to support patients and caregivers by providing reliable information, self-monitoring tools, and a communication channel with healthcare professionals. The study aims to assess the feasibility, patient engagement, and perceived quality of routine use of the app. It is hypothesized that its use will improve engagement, perceived quality, reduce anxiety and unplanned hospital visits, without introducing technological or privacy risks. The app supports information and data collection but does not replace clinical decision-making. Objectives Primary objectives: Assess feasibility and patient engagement through questionnaire completion. Evaluate perceived service quality using the Client Satisfaction Questionnaire (CSQ-8). Secondary objectives: Monitor unplanned hospital visits and adherence to chemotherapy. Assess anxiety (HADS-A), nutritional status, and global quality of life (PROMIS Global). Evaluate usability and acceptability of the app (SUS, UTAUT2 short version). Endpoints Primary endpoints include questionnaire completion rates and perceived quality (CSQ-8 score). Secondary endpoints include unplanned hospital access, chemotherapy adherence, anxiety levels, nutritional status, quality of life, and app usability/acceptability. Methods This is a prospective, interventional, multicenter study with consecutive enrollment of eligible patients. Each participant will be followed for 3 months, with most activities conducted remotely via the app. At baseline (T0), patients receive study information, provide consent, undergo training, register in the app, and complete initial assessments (clinical, socio-demographic, PROMIS Global, HADS-A). At 12 weeks (W12), follow-up includes all outcome questionnaires and data on unplanned hospital visits. The app includes features such as a personal diary (symptoms, weight, BMI, appointments), interactive questionnaires with tailored feedback, and educational content on nutrition, prevention, emotional support, and patient rights. Population Inclusion criteria: adults (≥18 years) with pancreatic cancer, access to a smartphone/tablet (or caregiver support), ability to consent, and understanding of Italian. Exclusion criteria include severe cognitive impairment, inability to use the app or complete follow-up, or withdrawal of consent. Sample Size and Analysis A total of 185 patients will be enrolled (accounting for 10% dropout), based on an expected 70% engagement rate. Analyses will be conducted on both intention-to-observe and per-protocol populations. Engagement will be analyzed as questionnaire completion rates, while other outcomes will be analyzed using appropriate statistical models (e.g., logistic regression, ANCOVA, descriptive statistics). An interim analysis at 50% enrollment is planned to address potential low engagement.

Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care

Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.

Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries

Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers. The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context. The main questions it aims to answer are: 1. Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)? 2. Can the care bundle prevent the development of new pressure injuries? 3. How well do caregivers learn and apply PI care knowledge after receiving the educational intervention? 4. How practical and acceptable is this care bundle for use in home settings? The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement. Participants and their caregivers will: Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care. Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them. The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.

Cancer Experience Registry (CER) for Cancer Patients and Caregivers

The Cancer Experience Registry®: An Online Survey Research Study to Understand the Experiences of Those Impacted By a Cancer Diagnosis. The Registry is a web-based platform to distribute cross-sectional and longitudinal surveys. Study surveys are designed based on input from advisor experts, including patients and caregivers, and focus on the social, emotional, physical, financial and decision-making experiences of those who have been diagnosed with cancer and their caregivers. Findings contribute toward enhancing care for patients, survivors and caregivers via programming and policy initiatives.

Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners

This randomized clinical trial studies couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners. A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.

Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose

This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.

Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center

This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Room setting preferences of patients and caregivers may help to understand their opinion regarding direct rooming system in the outpatient supportive/palliative care center.

PRACOH Prevention Breakdown Support Advice Guidance Disability

The main objective of this prospective interventional study is to evaluate the impact of the stay in the dedicated transitional care unit, through the achievement of the patient's primary objective set at admission, directly related to their specific needs. It is expected to improve knowledge regarding the prevention of situations of breakdown and exhaustion in the living environment of people with disabilities. * This would improve the life and care pathways as well as the support provided to these individuals and their families and friends. * It would limit the use of unscheduled care services in crisis situations, thereby improving the quality of care and life.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Stroke Mobility and Caregiver Outcomes

This study was designed to determine the effect of functional mobility levels of stroke patients on caregiver burden, anxiety, and depression in their caregivers.

Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community

In the realm of dementia care, the imperative to intervene at the earliest stages of cognitive decline is paramount. Recognizing this pivotal moment, the development of innovative and effective interventions becomes imperative in delaying dementia progression. Rooted in the Roy Adaptation Model and Zimmer's Theory of Psychological Empowerment, the investigator team has developed the empowerment-based dyadic strength-based intervention, which integrates strength-based and empowerment methodologies. Emphasizing a shift from deficits to capabilities, the strength-based approach fosters awareness of collective strengths within care dyads, facilitating coping mechanisms and resilience in the face of cognitive afflictions.

Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program

The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers. The main questions it aims to answer are: * Does the intervention improve diabetes self-management and cognitive function in older adults? * How is the implementation of the intervention in real-world settings? Participants will: * Attend weekly CDSMP session over a 6-week period (2.5-hour per session). * Provide feedback on their experience with the intervention through interviews and surveys.

ED PLWD/Care Partner Text Messaging

The purpose of this research study is to develop and test a text-messaging intervention for emergency department (ED) discharge care transitions experienced by caregivers of older adults with cognitive impairment.

Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients

This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers

Heart failure (HF) is a chronic and progressive condition that significantly affects patients' quality of life and increases the burden on family caregivers. Many patients struggle with self-care, including medication adherence, diet, and symptom monitoring. The REMIND HF (REmote Motivational INterviewing for Disease Management in Heart Failure) study aims to evaluate the effectiveness of remote motivational interviewing (MI) as a behavioral intervention to improve disease management and self-care among heart failure patients and their informal caregivers. The intervention consists of a series of online motivational interviews conducted by trained nurses over a 12-month period, focusing on lifestyle modification, self-monitoring, and patient-caregiver cooperation. The study will be conducted at the Wroclaw Medical University and collaborating centers. It will enroll 300 patients with heart failure (The New York Heart Association Functional Classificaion - NYHA class: II-IV) and their primary caregivers. Outcomes will include self-care behaviors, quality of life, psychological well-being, and health service utilization. The results will contribute to developing accessible, patient-centered models of heart failure management based on telehealth and behavioral support.

Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers

This trial studies the frequency of cachexia in ambulatory cancer patients and the psychological burden in patients and their primary caregivers who are referred to an outpatient supportive care clinic. Studying how often loss of appetite and/or unintentional weight loss (cachexia) occurs in patients seen in the supportive care clinic may help researchers develop new ways to lower stress in patients who suffer from loss of appetite and weight loss as well as their family caregivers.

Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers

This study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.

A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors

The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Real-World Study on the Impact of Atopic Dermatitis From a Caregiver Perspective

This study will address this gap by providing comprehensive data on disease burden from a caregiver perspective in a Canadian population, ultimately supporting improved clinical decision-making and healthcare resource allocation.

New Assessment System in Measuring Symptom Distress in Cancer Patients

This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.

Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders

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. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA by improving attentional regulation and psychological flexibility. 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. A pilot RCT was conducted to compare B-Mindful-Life to brief lifestyle education program in Chinese neurodegenerative disease caregivers, demonstrating promising acceptability, engagement, and effect for increasing PA (NCT06583018). Therefore, this full-power randomized clinical trial aims to rigorously examine its effectiveness and broader impact on this underserved population with several advancement: (i) broaden the population into all neurological disorder caregivers to test for the generalizability of the B-Mindful-Life program; (ii) conduct a 12-month follow-up to assess long-term effects of B-Mindful-Life intervention in real-life settings; (iii) modify outcome measures for targeted assessment. The primary outcome will measure the change in accelerometer-determined, 10-minute bout moderate-to-vigorous physical activity (MVPA) over a 7-day period from baseline to post-intervention.

RCT of QPS vs General Information Sheet

This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.