Treatment Trials

23 Clinical Trials for Various Conditions

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COMPLETED
Developing a Self-Management Program for People With Depression and Chronic Medical Illness
Description

This study seeks to adapt an existing chronic disease self-management program for people with both chronic medical illness and depression.

Conditions
COMPLETED
Evaluation of Housing First Initiative for Chicago Homeless With Chronic Medical Illness
Description

The study hypothesizes that early housing after hospitalization with case management integrated into the health and housing systems, will results in decreased use of costly health services (i.e., hospitalizations and Emergency Room visits) with no negative affect on health. To address this hypothesis the investigators implemented a Randomized controlled trial of 407 homeless adults with chronic medical illness in Chicago. Eligible homeless adults were enrolled during a hospitalization to intervention - Early housing with case management - or usual care - usual case management and housing options. The investigators followed the sample for 18 months with assessments at baseline, 1,3,6,9,12 and 18 months are enrollment. Study measures include Quality of Life, Health service use, Alcohol and Substance Use, housing and social and demographic characteristics.

COMPLETED
An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
Description

The purpose of this study is to determine if assigning older, chronically ill patients a healthcare coach after they leave the Emergency Department (ED) improves their quality of life and reduces the need for hospital-based care.

COMPLETED
Implementing an Emergency Department to Home Care Transition Intervention
Description

The purpose of this study is to determine whether a new way of educating/coaching chronically ill patients discharged from the Emergency Room will help them receive post-ER health care and strengthen their links to a regular, personal doctor.

COMPLETED
Wellness Self-Management
Description

Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in increased risk of disability, high health care spending, reduced quality of life and early mortality. Physical wellness is increasingly recognized as a key component of the VA's commitment to developing recovery-oriented and Veteran-centered mental health treatment. There is also growing recognition of the value of interventions that promote and improve patient self-management of chronic medical conditions. Building on the established efficacy of consumer facilitated medical illness self-management programming used in the general population and two recent adaptations for use with SMI adults in the public health sector (including the investigators' own evaluation of an intervention called Living Well), the investigators propose to complete a randomized controlled effectiveness trial of the Living Well intervention and simultaneously conduct a well specified process evaluation to optimize knowledge accrual regarding important factors that may improve future adoption, implementation and sustainability of the Living Well intervention in the VA system of care.

ACTIVE_NOT_RECRUITING
Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
Description

This research addresses the important public health crisis that people with serious mental illness (SMI) are dying10-20 years younger than the average population, primarily due to chronic, untreated medical conditions. This proposal tests the feasibility, acceptability, engagement of target mechanisms, and preliminary effectiveness of a peer-led and peer-developed intervention to improve the health and wellness of people with SMI by addressing underlying social determinants of health. This research will provide key information about target mechanisms underlying peer interventions and establish the evidence needed to advance to a full scale clinical trial.

COMPLETED
Group Self-Management of Depression and Medical Illness
Description

This project addresses the important public health need to reduce ethnic disparities in depression care by pilot testing and refining a culturally tailored, low-cost intervention for improving both depression and general medical outcomes among Latinos in safety net primary care settings. Cuerpo Sano, Mente Sana is a newly developed, lay-led, group self-management intervention that educates and empowers patients in their own health care and has the potential for widespread implementation and sustainability in primary care because it is responsive to patient, provider, and system preferences and needs. After completing an assessment of study clinic sites, we will conduct a pilot test of Cuerpo Sano, Mente Sana with 30 low-income, Spanish-speaking primary care patients. After reviewing pilot findings, we will revise the intervention and study plan, and will conduct a second pilot trial. After reviewing findings from this second trial, we will finalize the intervention and study plan in preparation for larger studies to test Cuerpo Sano, Mente Sana versus other interventions for addressing depression among Latinos in safety net primary care.

SUSPENDED
Virtual ACT for Adolescent Stress
Description

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.

Conditions
NOT_YET_RECRUITING
Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
Description

This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

COMPLETED
Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
Description

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.

COMPLETED
The Mental Health Effects of a Mindfulness App in Parents of a Child With Medical Complexity
Description

The number of children with special health care needs (CSHCN) in the US is nearly 20% of children representing approximately 14.6 million children nationally. A subgroup of CSHCN are children who have the most intensive healthcare needs known as children with a medical complexity (CMC). Parents of CMC experience many challenges. In addition to typical caregiver tasks, parents of a CMC may experience added stress and are more likely to experience higher rates of anxiety, depression, and post-traumatic stress disorder than parents of healthy children. This project aims to explore the acceptability and feasibility of a mindfulness mobile application for parents of a CMC as well as determine the effectiveness of mindfulness application use on stress, depression, and family management in parents of a CMC. Forty-five participants will be recruited and given access to a mindfulness application and instructed to use it at least 4 days a week for at least 10 minutes. Parents will fill out questionnaires on app usage, as well as stress, depression, and family management. This work will be accomplished through a pilot single arm approach.

RECRUITING
AIMS Medical Outcomes Study
Description

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

TERMINATED
Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)
Description

This study compares the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness comparator on self-regulation targets, specifically the primary outcome of emotion regulation. Secondary outcomes include sustained attention/response inhibition and interoceptive awareness. A secondary analysis will investigate the extent to which these self-regulation targets mediate the impact of MTPC group on action plan initiation.

WITHDRAWN
Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students
Description

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories. MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.

COMPLETED
Inpatient Consultation for High-Risk Chronically Ill Children Receiving Care in an Enhanced Medical Home
Description

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.

COMPLETED
Trial to Reduce Hospitalizations in Children With Medical Complexity
Description

The investigators hypothesize that an intervention, within an established patient-centered medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital utilization among medically complex children.

Conditions
COMPLETED
An Enhanced Medical Home for High-Risk Chronically Ill Children
Description

The purpose of this study is to assess whether an enhanced medical home providing comprehensive care is cost-effective in preventing serious illness (death, pediatric intensive care admission, or hospital stay \>7d) among high-risk chronically ill children.

COMPLETED
Comprehensive Care of Children With Medical Complexity
Description

Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. This model serves as the patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who work as hospitalists and within the PCP) and nurse practitioners to provide continuous care between hospital and primary care. This model seeks to provide a system of care that more fully meets the complex needs of the child and family, while implementing innovations in care delivery, fully implementing family-centered practice, and "embedding" behavioral, psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two outcomes: utilization and cost of care; and, evaluation of the experience of parents and their families.

COMPLETED
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
Description

This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behavior of people who are receiving care at a community mental health center.

COMPLETED
Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making
Description

The objective of this proposal is to test whether a multi-media website (www.prepareforyourcare.org) that is focused on preparing older adults for communication and medical decision making can help people engage in advance care planning.

Conditions
COMPLETED
Discussing Costs in the Doctor-Patient Encounter
Description

Background: - The costs of medical care have a major effect on patients during illness and treatment. Surveys with patients and doctors show that both are interested in discussing the costs of treatment. But they rarely talk about these issues. Both worry about whether it is appropriate to discuss financial matters in the clinical setting. They are also concerned about whether this topic will be an awkward one. Researchers are interested in studying how people want their doctors to talk to them about the costs of illness and medical care. Objectives: - To explore and better understand patients views on whether and how doctors should talk about the costs of illness and medical care. Eligibility: - English- or Spanish-speaking adults (at least 18 years of age) who are covered by health insurance. Design: * Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people will come together to discuss their thoughts and opinions. * A member of the research team will lead the group discussion. The leader will ask a list of questions about health care payment issues. Those in the focus group will discuss these issues. * Participants will receive a small cash payment and a light snack.

COMPLETED
Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
Description

This project evaluates the implementation and effectiveness of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. The project provides information to VA clinicians and managers about Veterans with schizophrenia or schizoaffective disorder who are overweight and/or who would like to return to competitive work. The project facilitates reorganization of care practices in order to get veterans needed and desired services around wellness and work. The project creates a platform that other clinical and research interventions can build upon to improve care, and is designed to inform a national strategy for implementing evidence-based care in schizophrenia.

COMPLETED
Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)
Description

Policy makers and consumers are increasingly concerned about the quality and efficiency of care provided to individuals with severe, chronic illnesses such as schizophrenia. These illnesses are expensive to treat and present significant challenges to organizations that are responsible for providing effective care. Occurring in 1% of the United States population, schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable and outcomes can be substantially improved with the appropriate use of antipsychotic medication, caregiver education and counseling, vocational rehabilitation, and assertive treatment. However, in the VA and other mental health systems, many patients with schizophrenia receive substandard care. Methods are needed that improve the quality of usual care for this disorder while being feasible to implement at typical clinics. To date, most efforts to improve care for schizophrenia have focused on educating clinicians or changing the financing of care, and have had limited success. We believe a more fundamental approach should be tried. While there are many potential strategies, experience in chronic medical illness and mental health support the efficacy of specific approaches. Collaborative care models are one such approach. They are a blueprint for reorganizing practice, and involve changes in division of labor and responsibility, adoption of new care protocols, and increased attention to patients' needs. Although collaborative care models have been successful in other chronic medical conditions, they have not yet been studied in the treatment of schizophrenia. We have developed a collaborative care model for schizophrenia that builds on work in other disorders, and includes service delivery approaches that are known to be effective in schizophrenia. The model focuses on improving treatment through assertive care management, caregiver education and support, and standardized patient assessment with feedback of information to psychiatrists. This project, "EQUIP" (Enhancing Quality Utilization In Psychosis) is implementing collaborative care and evaluating its effectiveness in schizophrenia.