166 Clinical Trials for Various Conditions
Conduct a randomized trial (n = 60: with n = 30 receiving music therapy and n = 30 receiving usual care) to investigate the feasibility, acceptability, and preliminary efficacy of the MAJOR CHORD music therapy intervention compared to usual care on (a) health-related quality of life (e.g., physical function, depression, anxiety, fatigue, and pain interference), (b) perceived stress, (c) self-efficacy, and (d) 30-day readmission rates
The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study.
This is planned as a feasibility study. The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction. The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device
Conduct a pilot study (n = 20) to explore the feasibility and acceptability of the MAJOR CHORD music therapy (MT) intervention (i.e., two in-person MT sessions prior to discharge and two virtual MT sessions post-discharge) and collection of patient-reported outcomes through 30 days after hospital discharge. The investigators will uncover any potential modifications that need to be made to the intervention and data collection process prior to initiating the randomized trial.
The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.
Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.
The investigators aim to perform a qualitative study exploring attitudes and perceived barriers to Long Acting Reversible Contraception (LARC), both implants and IUDs, among adolescent and young adults (AYA) with chronic illness at CHLA. While the literature examining barriers to LARC uptake is growing, its focus has been on older women and women who are not living with chronic illness. There remains a significant gap in the understanding of: 1. What adolescents and young adults from ethnically diverse, economically underserved communities know about LARCs 2. If and how LARCs fit into their considerations and decision making about contraception choices 3. Perceived barriers to LARC among AYA with chronic medical conditions 4. Information, perceptions, experiences that inform choices that may be unique to AYA living with chronic conditions Research Objectives 1. Explore the impact of the experience of living with chronic medical conditions on AYA patient attitudes toward and acceptance of LARCs 2. Identify AYA patient concerns and perceptions related to historical coercion and reproductive injustice experienced by minority communities that may reduce acceptance of LARC 3. Explore the relationship between patients' perception of pediatric subspecialty care providers' attitudes regarding sexual health and contraception guidance and patients' attitudes toward and acceptance of LARC 4. Identify factors related to patient's age, family's values, and medical condition, as well as historical events or legacies that may impact preference of implant vs intra-uterine device (IUD), independent of safety/medical contraindications, if choosing a LARC method. 5. Explore other social, cultural or psychological factors that influence perception and represent barriers to LARC access Hypotheses 1. The impact of chronic illness on AYA sense of bodily autonomy (including self-concept, history of other medical procedures, and concerns around mortality) reduces the attractiveness of LARC methods. 2. The intersectionality of multiple oppressions, including racism, xenophobia, sexism, and historical reproductive coercion and injustice implicitly reduce the attractiveness of LARC methods for AYA patients from minority communities with chronic medical conditions at CHLA. 3. Pediatric subspecialty providers' attitudes about sex, and comfort with providing patient-centered contraception counseling, as perceived by AYA patients, impact AYA patient attitudes towards and acceptance of LARC. 4. Preference of implant vs. IUD is related to patient's age, family values, and type of medical condition, as well as their knowledge of historical events related to contraception in their community, independent of safety/medical contraindications. 5. Additional perceived barriers, including fear or skepticism about LARC conferred by trusted sources of information such as family or social media, reduce the attractiveness and acceptance of LARC by AYA with chronic medical conditions
Background: Adolescents and young adults (AYAs) with chronic illnesses often struggle to develop illness self-management skills. Mobile health (mHealth) interventions have been developed for some specific chronic illnesses, but flexible interventions that can be generalized across conditions are needed to accelerate translation. Research Hypotheses: 1) Cell phone support (CPS) will increase medication adherence and self-management skills across a variety of health conditions; 2) CPS delivered by text message will outperform CPS delivered by phone calls; 3) Patients' perceptions of the human adherence facilitator (AF) will differ based on the mode of communication, text message versus phone calls. Design: A randomized, controlled, 3-arm pilot trial, following community-based participatory research (CBPR) principles, will test the impact of AF delivered by phone calls or text messages on medication adherence and illness self-management. Conditions will be CPS delivered by phone calls, CPS delivered by text messages, or usual care. Participants: Participants will include AYAs with diverse chronic illnesses aged 15-20 years (N = 60). Methods: This study will involve piloting CPS via different communication modes in a randomized trial, informed by CBPR principles. Questionnaires and focus groups will be used to understand how patients perceive the intervention and adherence facilitator. Main Outcome Measures: Outcomes will include medication and appointment adherence, pharmacy refill ratios, self-management skills, and perceptions of the AF. Innovation: This study will provide new knowledge regarding how to promote illness self-management skills, and may result in an mHealth intervention with the potential to widely impact supportive care for AYAs with chronic illnesses.
The high prevalence of chronic illnesses is a serious public health problem in the U.S., and more than 70 million adults age ≥50 have at least one chronic illness. Management of chronic conditions requires long-term use of complex treatment plans and can cause unintended consequences, such as increased risk of medication errors. Patient portals (PPs), a federally supported health information technology (IT), can be especially helpful for patients with chronic illnesses. Patients can now access their own health records and directly communicate with care providers through PPs. Prior findings suggest a great potential for using PPs to improve care quality, and the federal government funds healthcare organizations to implement this tool nationwide. Despite the potential benefits, the overall PP adoption rate in the U.S. is low. A lack of PP use among older adults has been addressed as a particular concern. When only older adults who use the Internet are considered, however, their proportion of PP use is similar to other age groups. A few studies also reported that older adults are receptive to PPs. In general, older adults need additional support for learning to use PPs, as they tend to be less familiar with technology. Currently, most older adults receive little or no PP support from their providers. This is an important gap in the nation's health IT initiative because without appropriate support, older adults will not be able to use this robust health tool, missing an important opportunity to improve their health outcomes. In an effort to fill this gap, the investigators developed and tested an older adult friendly Theory-based Patient portal eLearning Program (T-PeP) to support older adults in using PPs for their care. In the proposed feasibility study, the investigators plan to (Aim 1) optimize and implement a vendor-agnostic T-PeP and conduct formative and process evaluations; and (Aim 2) assess the preliminary impact of T-PeP on PP use and selected outcomes (PP knowledge, self-efficacy for PP use and health decision making, health communication, and medication reconciliation). If successful, this study could directly affect quality of care provided to older adults and the success of the national health IT initiative. Findings from this study will also provide hospitals, vendors, and policymakers with in-depth information on older adults' current PP usage patterns and other challenges in using various types of PPs at the national level.
The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention \& 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.
This is a group randomized trial of an intervention to improve chronic illness self-management.
The purpose of this project is to test the efficacy of Planet K, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' chronic kidney disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet K mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in adolescents and young adults with chronic kidney disease (CKD).
The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops. Investigators will examine the effectiveness of the Planet T1D mobile app and website in improving treatment adherence, disease-related knowledge, transition readiness, condition management, and the psychological correlates of these variables in youth with type 1 diabetes.
Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.
Millions of diverse Veterans live with severe and chronic illness for which they will face complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered chronic care, interventions to prepare Veterans for complex decision-making over the course of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a novel preparation guide designed to prepare Veterans to communicate with their surrogates and to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches communication and preparation skill behaviors (e.g., how to choose a surrogate and ask clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th grade reading level). This study aims to provide an impetus for changing the paradigm of advance care planning policies within the VA by moving beyond documentation of end-of-life wishes to the activation of Veterans to participate in ongoing communication of their values and goals - a process that is essential to fully realize patient-centered care.
The overall long term objective of this research is to improve health care utilization and quality of life of pediatric solid organ transplant recipients and family. Understanding the process of transition to a chronic medical condition during the acute (3 weeks after transplant) and long term (3 and 6 months) will significantly guide the development of clinical interventions aimed at maximizing adherence and family psychosocial adjustment.
Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Therapists will deliver the treatment in real time over the Internet and/or by telephone to increase treatment access. This planning grant seeks support for a two-site study (North Carolina and California) that consists of two phases. In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and RCBT. In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions. The purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. The importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. If 65% of Americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.
The study seeks to measure the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
The current body of research fails to acknowledge or understand what type of care children are giving to their siblings, yet it appears to be a common practice in many cultures. To address this gap, we propose to examine the role and activities children provide to siblings with a chronic illness or disability. Additionally, we seek to better understand what preparation, training, or support (either formal or informal) are provided to siblings who are actively engaged in the caregiving process. We will further examine indicators for quality of relationship between the two siblings and examine themes and associations. We will accomplish this through a mixed-methods design with the four following aims: Aim 1: Describe the role and activities of children (ages 7 to 17) while providing care for a sibling with a chronic illness or disability. Through a descriptive qualitative inquiry, we will ascertain details and experiences on caregiving from the perspective of the parent and the sibling (separately) regarding the care the sibling provides to the child with a chronic illness. Themes of connection, friendship, direct medical and physical care (such as feeding) will be explored. Open ended questions which support the aim will be asked indirectly and directly, such as, "What does your day look like when you are getting ready to go somewhere" verses "Can you describe how you help your sibling each day." Aim 2: Investigate ways in which children are educated, trained, or supported in their caregiving role. Both qualitative information and quantitative data will be gathered as guided by Aim 1. For example, if a sibling indicates they provide feeding support, they will be asked questions such as, "How did you learn or know how to help feed them?" Informants will also be asked questions regarding how often and how long they spend caring for their sibling using a Likert-type scale. Aim 3: Explore quality indicators of sibling relationship from the caregiving perspective. Parents (main caregiver) will be asked to complete a demographic survey and the sibling inventory of behavior survey, a psychometrically validated tool to measure indicators of the sibling relationship. Qualitative data from aims 1 and 2 and quantitative data from aim 2 will be used to understand how specific themes may positively or negatively be associated with a positive sibling relationship, as a positive sibling relationship serves as a protective factor for sibling outcomes10. Aim 4: Determine to what extent the quantitative data about parental-perceived sibling relationships converge with or diverge from the qualitative data about care provided by the sibling. For the mixed-methods data analysis, a joint display will be created to show a side-by-side comparison of the quantitative, qualitative, and integrated findings. Points of concordance, discordance, and expansion will provide rich insights into caregiving provided by siblings.
This study aims to test the effectiveness of a 6-week long virtual Acceptance Commitment group therapy as a non-pharmaceutical intervention to improving other functional outcomes for adolescents with a chronic medical condition in comparison to no treatment.
Children with acute and chronic illness undergo frequent, painful, and distressing procedures. This randomized control trial was used to evaluate the effectiveness of guided imagery (GI) vs virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing un-sedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response.
NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.
This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.
The investigators propose to study the feasibility, acceptability, usability and outcomes of a new clinical decision support system for clinicians of opioid therapy in the context of specialist palliative care for serious chronic illness. The system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. This clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment. Investigators will conduct clinician survey's to collection information about the clinical decision support system. Investigators will also conduct patient related questionnaires to determine any benefits or improvements in quality of life and symptom management from the clinical decision support system.
The investigators will conduct a pilot quality improvement trial to assess the impact of offering inpatient consultation to further optimize coordination and improve care for high-risk chronically ill children receiving comprehensive care in an enhanced medical home.
Depression is common among individuals with chronic illness such as chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD) and is a strong predictor of poor clinical outcomes and high rates of avoidable 30-day readmissions. While depression is a treatable condition, few people with depression receive effective treatment. The proposed study aims to develop a relational agent system to deliver depression treatment to patients with chronic illness and comorbid depression. While depression is a treatable condition, less than 36% of people with depression receive effective treatment. The proposed study aims to design and develop a technology-driven relational agent system to deliver a 6 module, blended approach of cognitive behavioral therapy and self-management education (RA-CBT) to support patients with CHF or COPD and comorbid depression. The relational agent is a human animation program that interacts with patients, integrates best practices from provider-patient communication theory, emulating the face-to-face conversational behavior of an empathic provider emphasizing nonverbal communicative behavior such as gaze, posture, gestures, etc. The RA-CBT program will be accessed via tablet technology by participants. The study investigators will conduct a pre-post feasibility study to understand the feasibility and acceptability of using the RA-CBT system and its effectiveness in treating comorbid depression. If successful, this new approach to depression treatment would immediately expand access and scalability for post-discharge mental health support in the care transition.
The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.
The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received.