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88 Illness Trials Near You
Power is an online platform that helps thousands of Illness patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerMulticenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Recent Cardiac Event, Unstable Angina, Uncontrolled Hypertension, Others
120 Participants Needed
End-of-Life Conversation Tools for Advance Care Planning
Columbus, Ohio
Compared to the general population, individuals from underserved communities are more likely to receive low quality end-of-life care and unwanted, costly and burdensome treatments due in part to a lack of advance care planning (ACP; the process of discussing wishes for end-of-life care with loved ones/clinicians and documenting them in advance directives).
This study will use existing, trusted, and respected social networks to evaluate two conversation-based tools intended to engage underserved individuals in discussions about end-of-life issue and motivate them to carry out ACP behaviors.
Through this study, investigators will learn how best to engage underserved populations in ACP so as to: 1) increase the likelihood that patients from underserved communities will receive high-quality end-of-life care; 2) address health disparities related to end-of-life treatments; and 3) reduce unnecessary suffering for patients and their families.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Hearing Or Speaking Difficulties, Others
1500 Participants Needed
The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19+
Key Eligibility Criteria
Disqualifiers:Chronic Ventilation, Prisoners
8100 Participants Needed
Airway Management for Critically Ill Children
Columbus, Ohio
This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\].
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:24 - 17
Key Eligibility Criteria
Disqualifiers:Prisoners, Tracheostomy, Pregnancy, Others
3000 Participants Needed
RSVpreF Vaccine for Bronchitis
Columbus, Ohio
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina.
Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Canada.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:60+
Key Eligibility Criteria
Disqualifiers:Metastatic Malignancy, End-stage Renal Disease, Unstable Cardiac Disease, Immunodeficiency, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
45000 Participants Needed
The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Severe Brain Injury, Neuromuscular Disease, Severe Liver Disease, Others
1100 Participants Needed
OM-85 for Recurrent Wheezing
Cincinnati, Ohio
This trial will test if daily OM-85 can reduce wheezing episodes in young children who often experience them. The study will focus on children aged 6 months to 5 years. OM-85 aims to help the immune system fight off infections that cause wheezing. OM-85 has been shown to reduce the risk of recurrent respiratory tract infections and wheezing attacks in children.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 72
Key Eligibility Criteria
Disqualifiers:Chronic Respiratory Diseases, Autoimmune, HIV, Others
Must Not Be Taking:Steroids, Immunosuppressants
288 Participants Needed
Oxygen Therapy Strategy for Burns
Cincinnati, Ohio
The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Age <18, Prisoners, Pregnancy
2000 Participants Needed
Targeted Oxygen Therapy for Critical Illness from Injuries
Cincinnati, Ohio
The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Age <18, Prisoners, Pregnancy, Others
6000 Participants Needed
Azithromycin for Wheezing in Preschoolers
Cincinnati, Ohio
This trial tests if giving preschool children with severe wheezing a medicine called Azithromycin can reduce their symptoms. The study includes children with and without certain bacteria in their noses. The goal is to see if the medicine helps by reducing bacterial infections or improving wheezing overall. Azithromycin has been studied for its potential to reduce severe asthma symptoms, with mixed results in different patient groups.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
1476 Participants Needed
Oral Bacterial Extract for Wheezing
Cincinnati, Ohio
This trial tests if giving Broncho-Vaxom® to high-risk infants can delay their first episode of wheezing illness. The medication is given regularly over a long period and aims to boost the immune system. The study focuses on infants aged 6-18 months who are more likely to develop asthma.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:6 - 18
Key Eligibility Criteria
Disqualifiers:Asthma, Seizures, Cardiac Disorder, Others
Must Not Be Taking:Corticosteroids, Immunotherapy, Immunosuppressants, Others
822 Participants Needed
Enoxaparin for Blood Clot Prevention
Cincinnati, Ohio
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:< 17
Key Eligibility Criteria
Disqualifiers:Bleeding, Surgery, Trauma, Coagulopathy, Renal Failure, Others
Must Not Be Taking:Antithrombotics
258 Participants Needed
Tenecteplase for Stroke
Toledo, Ohio
The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.
Stay on current meds
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Hemorrhage, Dialysis, Hypertension, Others
Must Not Be Taking:NOACs, Dual Antiplatelets, TPA
132 Participants Needed
Far-UVC Light for Respiratory Infections
Windsor, Nova Scotia
Elderly people who have multiple health problems are at higher risk of illness from viral respiratory infections, such as influenza (the flu) and COVID-19. This is especially true for residents in long-term care because the usual methods of infection control (handwashing, mask-wearing, and distancing) are difficult to enforce due to the memory problems of many residents and the frequently shared common spaces. It can also be difficult to prevent the spread of viral infections within long-term care because many residents are unable to tell their caregivers when they are feeling ill. Also, some elderly people do not show typical symptoms of infection (like fever), instead they may suddenly become confused or weak.
This study will test if a safe form of ultraviolet light (far-UVC) can be effective as an extra method of disinfection (in addition to usual manual cleaning) against airborne and surface viruses that can cause respiratory infections.
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-consent To Data Collection
500 Participants Needed
Indomethacin for Premature Birth
Pittsburgh, Pennsylvania
In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.
The investigators propose a blinded randomized controlled trial, a study design where babies born \<26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.
The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia and will enroll 500 babies born \<26 weeks or \<750 g birth weight over a period of 3 years. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born \<26 weeks of gestation can safely and effectively reduce severe brain bleeding.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:0 - 12
Key Eligibility Criteria
Disqualifiers:Duct Dependent CHD, Renal Anomalies, Others
Must Not Be Taking:Inhaled Nitric Oxide, Hydrocortisone
500 Participants Needed
Family Support Tool Intervention for Critical Illness
Pittsburgh, Pennsylvania
This trial tests a program that helps families of critically ill older adults by offering meetings with doctors and an online tool. It aims to improve communication, help families make informed decisions, and reduce their stress.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:No Surrogate, Imminent Death, Incarcerated, Others
1163 Participants Needed
In this trial, the investigators will examine the uptake of the evidenced-based IDEAL Goals program, a heart disease risk reduction program, while testing different implementation strategies with our partners in Michigan and Maryland who serve persons with serious mental illness (SMI).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Serious Mental Illness, Others
72 Participants Needed
Integrated Supportive and Palliative Care for Critical Illness
Pittsburgh, Pennsylvania
The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually, or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision makers often experience lasting psychological distress from the ICU experience. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 150 clinicians to determine whether early integration of specialty palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Key Eligibility Criteria
Disqualifiers:No Surrogate, Imminently Dying, Organ Transplant, Others
1400 Participants Needed
Smart Alert System for Hospital Care
Pittsburgh, Pennsylvania
Alerts related to outlier clinician behavior are generated in real-time by an intelligent system continuously scraping EHR (electronic health record) data. These alerts are passed to the bedside and their potential impact on bedside clinical behavior is evaluated.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
3000 Participants Needed
Music Therapy for Critical Illness
Pittsburgh, Pennsylvania
A randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Deafness, Musicogenic Epilepsy, COVID-19, Others
Must Not Be Taking:Neuromuscular Blockers
171 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
High-Fiber Formula for Gut Health in Critically Ill Children
Pittsburgh, Pennsylvania
This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:1 - 17
Key Eligibility Criteria
Disqualifiers:Allergies, Intolerances, Epilepsy, Others
Must Not Be Taking:Vasoactive Medications
40 Participants Needed
"PICU Up!" Early Mobility Intervention for Critically Ill Children
Morgantown, West Virginia
While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 18
Key Eligibility Criteria
Disqualifiers:Withdrawal Of Life Support, ECMO, Others
1440 Participants Needed
Transitional Care and Support for Critical Illness
Pittsburgh, Pennsylvania
The goal of this randomized control trial is to test an intervention designed to improve patient and family outcomes after critical illness compared to usual care. The intervention, called Post-Intensive Care Transitions, Rehabilitation and Family Support (PIC-TRFS) combines four elements: (1) health management; (2) rehabilitation; (3) social support; (4) care coordination. All patients and families enrolled in this study will have spent at least 48 hours in an ICU, be at risk for long-term functional impairment, and be discharged home. Although age of the patients will be restricted to those who are at least 50 years old and caregivers must be adults over 18 and all participants must speak English, the study will enroll all sexes, genders, races, and ethnicities. The main questions the study aims to answer are:
1. Compared to usual care, does PIC-TRFS improve patient quality of life at the end of the 6-month intervention period measured via PROMIS-Preferences (PROPr) score?
2. Compared to usual care, does PIC-TRFS improve patient physical, cognitive, and psychological functioning measured via PROMIS Physical, Cognitive, and Depression Computer Adaptive Test (CAT) at 6 and 12 months after discharge? Does it increase the number of days survivors spend alive at home in the 6 and 12 months after discharge? Does it improve patient and family trauma scores and dyadic quality of life, measured via the Impact of Events Scale-Revised and dyadic PROPr score?
Participants will:
* Complete Run-In assessments of symptoms and function in the hospital;
* Be randomized to intervention or control;
* Complete assessments of their function and quality of life at 0, 3, 6 and 12 months
* Control participants will get a brochure on the Post-Intensive Care syndrome and complete the assessments on the same schedule as those receiving the intervention
* Intervention participants will complete tele-health based check-ins providing health management, social support, and care coordination; and telehealth-based rehabilitation sessions focusing on patient functioning.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:No Caregiver, Transitional Care, Dependency, Others
320 Participants Needed
Remote Assessment Kits for Common Childhood Diseases
Pittsburgh, Pennsylvania
The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.
The main question it aims to answer are:
- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.
Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 9
Key Eligibility Criteria
Disqualifiers:Chronic Condition, Ward Of State, Others
100 Participants Needed
PICTURE-THIS Intervention for Post Intensive Care Recovery
Pittsburgh, Pennsylvania
This is a single-center pilot study examining the feasibility and acceptability of a transitional rehabilitation intervention, PICTURE-THIS, among critical illness survivors and their families. The intervention activities include transitional care coordination and activity-based rehabilitation delivered by a specialist team and integrated into usual care. There are three components to the assessment of feasibility and acceptability in this study:
1. User testing the PICTURE-THIS protocol to work out basic challenges to feasibility and acceptability.
2. Assessing the feasibility and acceptability of the user-tested PICTURE-THIS protocol.
3. Assessing the feasibility and acceptability of research activities required to test the clinical efficacy of PICTURE-THIS to improve outcomes among critical illness survivors and their family caregivers.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:No Caregiver, Non-English, Outside Pennsylvania
100 Participants Needed
CoachToFit Weight Management for Serious Mental Illness
Pittsburgh, Pennsylvania
This project addresses obesity in the population with SMI by evaluating a weight management program that is not only evidence-based, it is sustainable, transportable, appealing to patients, easy to use, and minimally burdensome to the healthcare system. This effort addresses two HSR\&D priority areas: 1) Mental Health: Testing new models of care to improve access, cost, and/or outcomes, and 2) Health Care Informatics: Building the evidence base for ehealth/mhealth tools.
Innovation: CoachToFit's use of mobile technology is an important innovation in VA service delivery and its user-centered design involving individuals with SMI was the first of its kind. CoachToFit is enhanced by data visualization in real-time via a web-based dashboard used by VA peer specialists and their supervisor. The Investigators are aware of no other evidence-based mobile platforms to help people with SMI reduce their weight
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Dementia, Bariatric Surgery, Pregnancy, Others
257 Participants Needed
Peer-Delivered Cognitive Behavioral Social Skills Training for Serious Mental Illness
Pittsburgh, Pennsylvania
The Veterans Health Administration (VHA) is advocating that Veterans with serious mental illness (SMI) receive recovery-oriented, rehabilitation approaches that target real-world functioning. One such approach is Cognitive-Behavioral Social Skills Training (CBSST). Unlike traditional cognitive-behavioral therapy, CBSST is a more recovery-oriented psychosocial rehabilitation intervention that teaches Veterans with SMI to correct errors in thinking and build social skills. While effective, CBSST has only been tested when facilitated by masters- or doctoral-level therapists, which limits its use in VHA. However, the investigators' pilot data shows that Peer Specialists-individuals with SMI who are hired and trained to use their own recovery experience to assist others with SMI-can also provide CBSST (called CBSST-Peer). Stand-alone social skills training (SST) is also a recovery-oriented program that VHA is attempting to rollout nationwide for Veterans with SMI. A few Peer Specialists have been trained to co-lead SST with professionals. However, SST is not widely implemented because professionals are busy and Peer Specialist delivered SST has not been tested. This study will evaluate the effectiveness of Peer Specialist-delivered CBSST and SST, which would increase access Veterans with SMI have to effective treatment. The investigators' aims are: Aim 1 (Effectiveness): To compare the impact of CBSST-Peer on outcomes in Veterans with SMI to Veterans receiving Peer Specialist-delivered SST groups of equal duration and to treatment as usual. The investigators will also assess fidelity of SST and CBSST. Aim 2: (Helpfulness of CBSST/SST--Peer and implementation barriers and facilitators): To use focus groups with patients and interviews with Peer Specialists and other staff to assess perceptions of SST- and CBSS Peer and identify potential barriers and facilitators to future implementation. Methods: This is a randomized, Hybrid 1 trial involving 252 Veterans with SMI (n=126 each from Pittsburgh, San Diego) comparing 3 treatment arms: CBSST-Peer vs. SST-Peer vs. treatment as usual. Hybrid 1 trials test the effectiveness of an intervention and collect implementation data that could inform its future adoption. At each site, across 6 waves (a wave = 1 CBSST-Peer and 1 SST-Peer group), 2 Peer Specialists will co-lead 12 groups, each lasting 20 weeks. Peer Specialists will be trained and receive an hour of supervision weekly by the CBSST developers. Master trainers from the SST rollout will train and supervise Peer Specialists in each site. All three arms' sessions will be taped and 25% rated for fidelity on standardized measures. A survey battery that assesses functioning, quality of life, recovery, and symptoms will be administered to the Veterans in each wave at: baseline, mid-intervention (10 weeks), end-of-intervention (20 weeks), and follow-up (32 weeks, 3 months post intervention). The investigators will examine all outcomes using Hierarchical Linear Models (HLM), with treatment condition included as a time-invariant covariate, and random intercepts for person and random slopes for time. Relevant covariates will include site, treatment attendance, symptom severity, service use, and demographic variables. The investigators will evaluate the effect for treatment conditions (CBSST-Peer vs. SST-Peer vs. treatment as usual group) in the expected direction and the time X group effect. Qualitative data on SST- and CBSST-Peer helpfulness and implementation factors will be collected from 8 focus groups, audio-recorded from a random sample of Veterans who participated in SST- and CBSST-Peer. Interviews will be conducted with participating Peer Specialists (n=approximately 8 per site), and key mental health staff (n=3-4 per site). The qualitative interviews and focus groups will be analyzed using rapid assessment, a team-based, iterative data collection and analysis approach providing data on the barriers and facilitators to future implementation of SST- and CBSST-Peer. Innovation: No study has tested peer-delivered SST or CBSST, or compared the two, in a rigorous trial. Significance/Expected Results: CBSST and SST are not widely available. If SST- or CBSST-Peer is effective, it could greatly increase the delivery of evidence-based services Veterans receive and enhance the services by VHA Peer Specialists.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Medication Changes, Recent CBSST/CBT/SST, Hospitalization, Severe Mental Illness, Cognitive Impairment, Others
201 Participants Needed
Donanemab for Early Alzheimer's Disease
Farmington Hills, Michigan
This trial is testing different doses of donanemab, a drug aimed at helping people with early Alzheimer's disease. Donanemab has shown rapid reduction of brain amyloid in early Alzheimer's disease. The study will look at how often and how severely participants experience a side effect involving brain swelling. Researchers also want to find out which patient characteristics might predict this side effect.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:60 - 85
Key Eligibility Criteria
Disqualifiers:Not Listed
800 Participants Needed
IIMR vs CDSMP for Mental Health Disorders
Louisville, Kentucky
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Cognitive Impairment, Others
600 Participants Needed
E-Cigarettes for Smokers With Mental Illness
Louisville, Kentucky
To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:Asthma, Cognitive Impairment, Pregnancy, Others
250 Participants Needed
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Frequently Asked Questions
How much do Illness clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Illness clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Illness trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Illness is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Illness medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Illness clinical trials?
Most recently, we added Combined Rehab Therapy for Acquired Weakness, ICUconnect for Palliative Care in Older Adults and Smart Alert System for Hospital Care to the Power online platform.
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