Clinical Research Directory

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.

AI-Supported CBT-Based Psychoeducation for Caregivers of Individuals With Schizophrenia

Schizophrenia is a chronic mental disorder that affects the diagnosed individual and the family members involved in the care process from a biopsychosocial perspective. The course of the illness, the recurrence of symptoms, and the high level of care required can increase the burden on caregivers and make it difficult for them to express their emotions. Structured psychoeducation and cognitive-behavioral interventions have been reported to be beneficial for caregivers in managing these challenges. The aim of this study is to develop an AI-supported psychoeducation program based on a cognitive-behavioral approach for caregivers of individuals diagnosed with schizophrenia and to evaluate the program's impact on caregiving burden and the level of emotional expression. The six-week program will cover topics such as the caregiver role and burden, schizophrenia, the thought-emotion-behavior cycle, recognizing and expressing emotions, effective communication, setting boundaries, seeking support, signs of relapse, and crisis planning. Content based on scientific literature will be evaluated by experts. Artificial intelligence will facilitate interaction with the content, participation in activities, the application of skills, and structured feedback. The system will not provide clinical assessments, diagnoses, or personalized treatment recommendations; participants will be referred to appropriate healthcare services in situations requiring professional evaluation. The study will be conducted using a quasi-experimental design with pre-test and post-test control groups. A total of 88 caregivers will be recruited, with 44 assigned to the experimental group and 44 to the control group. The program will be administered to the experimental group, while the control group will receive routine care. Data will be collected using the Caregiver Descriptive Information Form, the Zarit Caregiver Burden Scale, and the Emotional Expression Scale. A Program Evaluation Form will also be used for the experimental group. The program to be developed is expected to reduce the caregiving burden on caregivers and improve their ability to express emotions. It is anticipated that the findings will contribute to psychiatric nursing practice, the development of AI-supported psychoeducation programs, and the strengthening of psychosocial support provided to caregivers.

"AFRONTA Emotional Care" Intervention for Family Caregivers of Children With Cancer.

The objective of the protocol is to evaluate the acceptability and feasibility of "AFRONTA Emotional Care" to reduce caregiver burden in family caregivers of children with cancer at a children's cancer foundation in Pachuca, Hidalgo, Mexico. The main questions to be answered are: * What is the acceptability and feasibility of "AFRONTA Emotional Care"? * Does the AFRONTA Emotional Care intervention reduce caregiver burden in family caregivers of children with cancer? The researchers will * Implement a series of therapeutic sessions based on a dialogue circle where * They will guide specific objectives related to caregiver burden characteristics * They will administer a questionnaire before and after the sessions to evaluate the results The participants will * Sign informed consent * Attend the dialogue circle sessions * Develop exercise-based activities that promote active listening, respect, and empathy. * Wait your turn to speak and speak up (converse) * Promote the collective development of ideas and the resolution of care-related conflicts.

Peer Support for Family Caregivers of Older Adults Living With Dementia

Family caregivers of people living with dementia are at high risk of poor health when caregiving for their loved one. Peer Support for Family Caregivers of Older Adults Living with Dementia (Pair 2 Care©) is a simple, nonjudgmental, flexible, and potentially scalable peer support program developed with and for family caregivers along with former (previous) caregivers, community leaders, and healthcare providers. Using the experiences of trained former caregivers as mentors to current caregiver mentees, Pair 2 Care© may lower caregiver depressive symptoms and promote health and well-being of current caregivers, their loved ones, and former caregivers while informing future Alzheimer's disease and Alzheimer's disease-related dementia caregiving policy.

Nurse-Led Caregiver Support Program in Home Palliative Care

This randomized controlled trial evaluated a nurse-led caregiver support program for family caregivers of patients with cancer receiving home palliative care. A total of 162 caregivers were randomly assigned to the intervention or control group, with 81 caregivers in each group. The intervention included six weeks of structured education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare use. As-needed telephone consultation remained available through week 18. Both groups received routine home care services. The primary outcome was caregiver competency. Secondary outcomes included caregiver burden, self-efficacy, patient palliative care concerns assessed using the Integrated Palliative care Outcome Scale, emergency department visits, and hospitalizations. Questionnaire assessments were conducted at baseline, week 6, and week 18.

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.

Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use

This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.

Multiple Sclerosis Severity and Caregiver Health Outcomes

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.

DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes

The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. The study will include children and adolescents aged 6 to 17 years with Type 1 diabetes who live in Pakistan. The main questions it aims to answer are: * Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence? * Does using DiaBuddy along with usual diabetes care reduce caregiver burden? * Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes? * Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers? Researchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone. Participants will: * Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities. * Receive diabetes education, reminders, and self-management support through the app. * Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden. * Have blood sugar control assessed through laboratory-verified HbA1c measurements. * Attend scheduled follow-up assessments at approximately 3 and 6 months. * Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.

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.

Boosting Resources for Tracheostomy Care at Home

The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are: * What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home? * How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge? Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

The Effect of Music on Anxiety and Caregiver Burden in Family Caregivers of Patients With Lung Cancer

This randomized controlled trial evaluated the effects of a 7-day self-selected music intervention on caregiver burden and anxiety among first-degree family caregivers of patients with lung cancer. Fifty caregivers were randomized to an intervention group (n=25), who listened to selected music for 30 minutes daily for 7 days, or a control group (n=25), who received routine care. Caregiver burden and anxiety were assessed before and after the intervention. The intervention was associated with significant reductions in caregiver burden and trait anxiety, suggesting that self-selected music may be a feasible, low-cost complementary nursing intervention for family caregivers.

Thrive at Home: A Virtual Reality Social Intervention for Older Adults

The goal of this clinical trial is to evaluate whether a virtual reality (VR) based social platform can improve mental health and social connection for older adults who receive in-home care. Specifically, the study aims to determine if the VR program reduces loneliness, depressive symptoms, and boredom while increasing social connection and well-being among older adult participants. It also explores whether access to the VR program reduces caregiver burden and depressive symptoms for family caregivers. Researchers will compare an immediate-start group to a waitlist control group to assess whether the VR program improves outcomes compared to standard home care alone. Both groups will eventually receive the intervention. Older adult participants will use a VR headset at home to join group activities three times a week. These sessions include social activities with local peers and live-hosted group activities. A family caregiver or home care professional may be present during sessions if needed for support. Over a 12-week study period, older adult participants will complete three surveys assessing their mood, social connection, and well-being. Family caregivers of participating older adults are also invited to join an optional caregiver substudy. Caregivers who enroll in the substudy will not participate in the VR activities themselves, but will complete three surveys at the same time points over the 12 weeks to share their own well-being and caregiving experiences.

Psychological Resilience and Quality of Life Among Caregivers of Patients With Schizophrenia

Schizophrenia is a severe and chronic psychiatric disorder that requires long-term care management, placing family members who serve as informal caregivers under substantial psychological, physical, and financial strain. While caregiver burden, anxiety, and depression are well-documented challenges in this population, psychological resilience can serve as an essential protective buffer against chronic stress. This study aims to evaluate the levels of psychological resilience and Quality of Life (QoL) among family caregivers of patients with schizophrenia compared to a matched control group of caregivers of healthy individuals. This observational case-control study will be conducted at the Neuropsychiatry Department (inpatient wards and outpatient clinics) of Assiut University Hospital in Assiut, Egypt. Primary informal caregivers aged 18 to 65 years who reside with and care for a patient clinically diagnosed with schizophrenia (DSM-5 / ICD-11 criteria) for at least 6 months will be compared to matched caregivers of healthy individuals recruited from the community. Participants will undergo structured face-to-face clinical interviews to assess: * Quality of Life: Evaluated across physical, psychological, social, and environmental domains using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF). * Psychological Resilience: Measurement of individual coping ability, personal competence, and adaptability under stress. * Caregiver Burden: Quantified using the Zarit Burden Interview (ZBI). * Psychiatric Distress: Clinician-administered assessment of anxiety severity via the Hamilton Anxiety Rating Scale (HAM-A) and depressive symptoms via the Hamilton Depression Rating Scale (HAM-D). The findings aim to identify sociodemographic and clinical predictors influencing caregiver well-being and provide evidence to guide targeted psychosocial support and intervention programs.

WECARE: A Personalized Intervention for High-Demand Dementia Caregivers

The goal of the project is to evaluate Wellness Enhancement for Caregivers (WECARE), a digital behavioral intervention for high-demand dementia caregivers. The behavioral intervention is culturally tailored to the target users and will be delivered via the WECARE mobile app and accompanying website, accessible only to verified enrolled participants. Participants will engage with digital learning materials and supportive resources over the course of the program. The goal is to determine whether this approach improves caregiver well-being and reduces stress related to caregiving.

DECIDE: Dyads and Families

The purpose of this study is to design and test a decision-making program that is tailored to support adult daughters making healthcare decisions for their parents who are living with memory loss to improve the quality of life of African American families. There are two phases of this research study. The first phase will collect information by surveys and/or interviews. The surveys and interviews will ask questions about demographics (e.g., age, race/ethnicity), culture, health, family dynamics, caregiving, and healthcare experiences. The surveys will be completed by all eligible adult daughters and parents with memory loss in pairs. The interviews will be completed by a smaller number of pairs and by all former adult daughter caregivers. The general scope of topics is caregiving experiences, cultural identity, healthcare decisions for persons living with Alzheimer's disease, and related dementias, health, and well-being. The research team will identify and examine key factors that will lead to designing and testing the feasibility of a culturally tailored prototype intervention for African American dementia dyads/families of persons living with mild to moderate Alzheimer's disease and related dementias.

LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorectal Cancer

This is a single center single-arm, pilot study of proactive and early connection with free legal care services for patient-caregiver dyads affected by colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants (i.e. patient-caregiver dyads) will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 3 months, however, participants may continue to access free personalized legal care services beyond this period.

Artificially Intelligent Robot Control

The purpose of the study is to compare the impact of standard asthma education with the standard + Artificially Intelligent Robot (AIR) Control intervention.

CaknaStrok Education Package for Stroke Caregivers

This study evaluated the feasibility and potential effectiveness of the CaknaStrok Education Package (CEP), a culturally tailored education package developed to support informal caregivers of stroke survivors. The package consists of a mobile health application and a Malay-language caregiving guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. The study compared caregivers receiving the CaknaStrok Education Package in addition to usual care with those receiving usual care alone. The study assessed outcomes related to caregiving burden, quality of life and psychological well-being, as well as the feasibility of implementing the intervention within routine stroke care.

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.

Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems

The goal of this study is to test the efficacy of brief video interventions parental internalized stigma and stigma-related outcomes (e.g., treatment intentions, caregiver burden, secrecy) among parents (ages 25-50) of children ages 6-18 with depression, ADHD, or substance use problems. Timely identification and treatment of mental health problems in youth is a public health priority. However, many youth do not receive treatment, and stigma has been identified as the primary barrier to help-seeking. Parents experience stigma related to their children having mental health problems, which has been associated with reduced help-seeking and increased parental distress. Prior experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing mental health stigma and increasing help-seeking. In this 4-arm RCT, the investigators will recruit parents aged 25-50 using an online crowdsourcing platform, to test the efficacy of BVIs featuring a personal parent narrative of their experience with their child's a) depression, b) ADHD, or c) substance use, or d) a control condition that provides general written psychoeducational information without social contact.

Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

Cognitive impairment and reduced quality of life are frequent consequences of ischemic stroke and can also affect family caregivers, who often assume caregiving responsibilities with limited preparation. Evidence regarding rehabilitation interventions initiated during the early poststroke period remains limited. This randomized clinical trial evaluates two independent interventions initiated after baseline assessment and randomization, approximately 20 days after the index stroke: a structured computerized neuropsychological rehabilitation program for the patient and a structured psychoeducational program for the primary family caregiver. A 2×2 factorial design allows the main effect of each intervention to be estimated within a single sample and permits an exploratory assessment of their interaction. The primary outcome is quality of life at 3 months after stroke, measured using the CAVIDACE total direct score and completed by a family informant. Secondary outcomes include cognitive performance, functional status, mood, and caregiver burden. Molecular biomarkers and acute structural neuroimaging variables are examined as exploratory outcomes.

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.

Online FBT-DBT Caregiver Intervention for Caregivers of Individuals With Anorexia Nervosa

Anorexia nervosa (AN) is a severe psychiatric disorder characterized by a chronic and relapsing course. Caregivers of individuals with AN often experience substantial caregiving burden, emotional distress, and impairment in family functioning due to their ongoing responsibilities in meal supervision, treatment support, and symptom management. Despite the critical role of caregivers in treatment and recovery, evidence-based interventions specifically targeting caregiver burden remain limited in China. This study aims to develop and evaluate an online intervention integrating Family-Based Treatment (FBT) and Dialectical Behavior Therapy (DBT) for caregivers of individuals with AN. FBT emphasizes empowering caregivers to support nutritional rehabilitation and recovery, whereas DBT provides skills in emotion regulation, validation, and effective communication. The integration of these approaches may help caregivers reduce distress, improve caregiving skills, and enhance family functioning. This study will employ a randomized controlled trial design. A total of 80 primary caregivers of individuals with AN will be recruited and randomly assigned to either an online FBT-DBT intervention group or an online supportive psychological intervention group. Both interventions will be delivered in a group format over 12 weeks. Assessments will be conducted at baseline, 4 weeks, 8 weeks, post-intervention (12 weeks), and at 1-month and 3-month follow-up. The primary outcome will be caregiver burden. Secondary outcomes will include psychological distress, negative emotional experiences, and the impact of eating disorder symptoms on the family. The study aims to determine the effectiveness of the online FBT-DBT intervention in reducing caregiver burden and psychological distress and to evaluate whether it provides greater benefits than supportive psychological intervention. Findings may contribute to the development of accessible and evidence-based caregiver interventions for families affected by AN in China.