Clinical Research Directory

Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism

Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.

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.

Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers

The global cost of dementia is over 818 billion, and a further rise is expected in the next decade. While family caregiving is the backbone of the formal care service, promoting "living well with dementia" needs to extend to a dyadic perspective to address the needs of persons with dementia (PwD) and their caregivers. Unique to dementia caregiving, imbalanced exchange in the assistance, interaction, relationship and autonomy between the partners in a care dyad always challenges their social interaction and relationships. Such eroding dyadic dynamics not only worsens the mental health of caregivers, but also compromises the quality of caregiving, fosters more dementia deterioration, and eventually complicates the caregiving process. Nevertheless, least attention is directed to dyadic dynamics in promoting living well with dementia. Partner exercise is designed in a way which requires collaboration of two members to enable the workout of each other. In addition to the benefits of exercise on dementia symptom control and caregiver's stress management, partner exercise provides a meaningful encounter to encourage reciprocity, collaboration and relationship closeness within the care dyad. This is a sequential mixed-method study including a multicenter RCT to evaluate the effects of the 16-week enhanced BUDPA and a descriptive qualitative study to explore the care dyad's overall engagement experience and perceptions. The study will be conducted in 8 elderly community centres operated by four NGOs. The primary aim of the study investigates the effects of a 16-week enhanced BUDPA program on the health and dyadic dynamic of the persons with dementia and their family caregivers (Objective 1-3). The secondary aim explores dyads' overall experience in program engagement, particularly in terms of perceived benefits, challenges, and experience in self-directed practice (Objective 4). The primary outcomes include PwD's cognitive function and caregivers' mood status. We hypothesize that the 16-week enhanced BUDPA program will be more effective than usual care immediately post-test (T1: week 16) and 3 months (T2: week 29) and 6 months thereafter (T3: week 42) in: 1. improving cognitive function, NPS and HRQL of persons with mild to early-moderate dementia. 2. improving the affect, positive aspects of caregiving, and HRQL of family caregivers. 3. improving the dyadic dynamic between the person with dementia and family caregiver in a dyad.

Caregivers Preparing for Their Own Health Care Emergency

The proposed research will develop and test an online Emergency Preparedness Toolkit to help caregivers prepare for their own unexpected health events. Caregivers of persons with dementia often ignore their own health needs as their primary focus is the care of the person with dementia. This can lead to a caregiver delaying their own care and subsequently emergent health events. The Emergency Preparedness Toolkit provides guidance to the caregiver as to how to identify and transfer care to a standby caregiver. The goal is to provide a caregiver with the security and comfort that the person with dementia will be well cared for while they care for their own health needs.

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Hispanic Adapted and Culturally Relevant Exercising Together

The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.

WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT

The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are: * How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners? * Does the WeCareToFeed Dysphagia tool help improve patient outcomes? * Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool? * Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)? Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care). Participants will: * be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only). * be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.

Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department

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.

From Kitchen to Clinic

Children receiving cancer treatment often experience nutrition-related challenges, such as changes in appetite, weight, and food intake, due to treatment side effects and the demands placed on families during care. These challenges can increase caregiver stress, reduce diet quality, and contribute to short- and long-term health risks for children. While medically tailored meals have been shown to improve nutrition and reduce burden in adults with serious illness, their use in pediatric cancer care has not been well studied. This pilot study will evaluate the feasibility and acceptability of a 12-week, family-centered food-as-medicine program for children undergoing active cancer treatment and their caregivers. The program combines weekly delivery of medically tailored meals with individualized caregiver coaching provided by registered dietitian nutritionists. During the first eight weeks, families receive full meal support and weekly coaching sessions, followed by a four-week transition period with tapered meal delivery and bi-weekly coaching to support sustainable nutrition practices. A total of 60 pediatric patients and their caregivers will be enrolled at the Children's Hospital of Philadelphia. The study will assess whether families can be successfully recruited and retained, whether they are able to participate in study activities, and whether the program is acceptable and usable during cancer treatment. The study will also explore preliminary effects on children's dietary intake, weight and growth patterns, treatment tolerance, household nutrition security, and caregiver stress and burden.

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

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.

Quality of Life of Caregiver of Cancer Patients

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.

Swallowing Impairments in ICU Survivors and Community-Dwelling Adults

Post-intensive care syndrome (PICS), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (ICU) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. Yet, little is known about the relationship between PICS, swallowing difficulties (dysphagia), and other ICU-related negative outcomes such as frailty and Alzheimer's Disease and Related Dementias (ADRD). The primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult ICU survivors with PICS.

Effects of Craniosacral Therapy in Primary Caregivers of Individuals With Special Needs

This study aims to evaluate the effects of craniosacral therapy on pain, body awareness, depression, and quality of life in primary caregivers of individuals with special needs. Primary caregivers often experience physical and psychological burden due to long-term caregiving responsibilities. Craniosacral therapy is a non-pharmacological, manual therapy approach that may help reduce pain, improve body awareness, and support overall well-being. In this study, eligible primary caregivers will be assigned to either a craniosacral therapy group or a control group. The intervention group will receive craniosacral therapy sessions, while the control group will receive no therapeutic intervention during the study period. Outcome measures related to pain, body awareness, depression, and quality of life will be assessed before and after the intervention. The results of this study may contribute to a better understanding of the potential benefits of craniosacral therapy for improving the physical and psychosocial health of primary caregivers of individuals with special needs.

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

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.

Learning Skills Together Family Caregiver Complex Intervention

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.

Evaluating the Efficacy of the Pain Identification and Communication Toolkit

This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.

Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease

Informal caregivers of people with Alzheimer's disease experience high physical and psychological burden, increasing their risk of frailty, anxiety, and caregiver burnout. This randomized controlled trial aims to evaluate the effectiveness of a combined strength training and progressive muscle relaxation program compared with progressive muscle relaxation alone. The intervention will last 10 weeks, with assessments conducted at baseline, post-intervention, and at a 3-month follow-up. Primary outcomes include frailty, anxiety, and caregiver burden.

Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure

The purpose of the Aim 3 study is to conduct a pilot randomized controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.

Telephone Support in Advanced Gastrointestinal Cancer

The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are: Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support? Participants in both study conditions will: Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

The Effect of Watson Human Care Theory and Acceptance and Commitment Therapy-Based Counseling Program Applied to Parents of Pediatric Palliative Care Patients on Value-Based Life and Care Burden

This study aims to examine the effect of Watson Human Care Theory and Acceptance and Commitment Therapy-based counseling program applied to parents of pediatric palliative care patients on value-oriented living and care burden.

Effectiveness of a Person-Centered Lifestyle Intervention in Mothers of Children With Autism Spectrum Disorder

Mothers of children with autism spectrum disorder (ASD) experience substantial physical, emotional, and social strain due to the demands of continuous caregiving. These responsibilities often limit opportunities for health-promoting behaviors and contribute to elevated stress, fatigue, sleep disturbances, and reduced wellbeing. This study aims to evaluate an intervention designed to support the health and wellbeing of mothers who serve as primary caregivers of children with ASD. The intervention focuses on enhancing stress-management skills, improving participation in meaningful daily activities, and promoting balanced health behaviors through structured psychoeducational and occupation-based strategies. The goal of the trial is to determine whether a holistic, individualized, and occupation-centered approach delivered by occupational therapists can improve maternal wellbeing and support sustainable engagement in health-promoting routines.

Emotion and Symptom-Focused Engagement (EASE) for Caregivers

The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is: \- Is EASE plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months? For the primary outcome analysis, area under the curve will be calculated for each participant. The statistical significance of the difference between arms will also be evaluated. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.

I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms

This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.