582 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would 1. decrease burnout 2. improve sleep and work engagement. Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.
The investigators will conduct a randomized controlled trial to evaluate the impact of an outreach campaign designed to increase engagement with Pack Health, a Quest Diagnostics wellness program providing individual health coaching for weight management and diabetes prevention. While employee wellness and disease-management programs have the potential to improve wellbeing and reduce healthcare costs, their effectiveness is often undermined by low engagement and selection bias in participant comparisons. This study will test whether an outreach approach that auto-enrolls eligible individuals-employees and their spouses/domestic partners-into the program, with the option to opt out, can increase engagement and improve health outcomes compared to the standard invitation-based approach.
The goal of this prospective randomized clinical trial is to learn if a pharmacist-provided personalized medication review (PMR) that discusses pharmacogenomic test results will improve medication outcomes. The primary aim is to identify patients within the Pitt/UPMC employee health programs who are most likely to benefit from PGx testing based on prescription history. The second aim is to determine the effect of the pharmacist-provided PMR including PGx test results. Participants 18 years of age and older who have undergone PGx testing through a independent biobanking study (Pitt+Me Discovery) will be randomly assigned to receive PMR with a discussion of PGx test results or PMR without PGx results. Those who receive PMR only will receive PGx results one year after their PMR. Researchers will compare the groups to see if a pharmacist-provided PMR using PGx test results will lead to better medication outcomes and lower medical costs.
Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being.
The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby. The main question\[s\] the study aims to answer are: * Can the Her Health program increase access to healthcare in the first year postpartum? * Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system? Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum. Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.
The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns. This study is being done to find out if the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach is defined as care most cancer survivors get for their cancer-related sexual concerns. Participants will complete a questionnaire and if they qualify, they will be assigned to one of sixteen groups of participants. Groups will get access to various kinds of help through an Internet-delivered program called SHINE, which was designed and is run by researchers at the University of Virginia Center for Behavioral Health and Technology. All groups will get access to education about sexual health after cancer: either a standard education website or an enhanced education web program. Groups may also receive up to three additional web programs on: talking to your clinicians about sexual concerns, and/or talking to your partner about sexual concerns, and/or increasing intimacy. Participants are asked to complete the SHINE program within 12 weeks. After participants finish this 12-week period, the study team will ask them to complete a questionnaire to check in with the participant. The participant will be asked one additional time 12 weeks later to complete another questionnaire to see how the participant is doing. A participant will be in the study for 24 weeks.
This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).
There is a large body of evidence demonstrating that Acceptance and Commitment Therapy (ACT) can be delivered in a self-guided format to improve mental health among college students. However, previous research indicates there are challenges in engaging students in adhering to these time intensive, multi-session self-guided resources. Brief self-guided single session interventions could provide an accessible and acceptable intervention that is easier to adhere to, given their lower intensity and response effort for participation. This proposed study seeks to evaluate a single session online ACT Guide Lite intervention in a sample (n = 100) of Utah State University (USU) college students 18 years of age or older. A randomized controlled trial (RCT) design will be used in which students are randomized to receive ACT Guide Lite or to a waitlist condition in order to test the following predictions: (1) participants assigned to ACT Guide Lite will improve more on the primary therapeutic process of change, psychological flexibility, relative to those not receiving intervention, (2) participants assigned to ACT Guide Lite will improve more on distress, well-being, and interest in seeking help, relative to those not receiving intervention, (3) ACT Guide Lite will be acceptable to college students as indicated by recruitment rates, rates of completing ACT Guide Lite, and self-reported program satisfaction, and (4) areas for future program revisions will also be identified through participants' written feedback on their experiences using the program. USU students will be recruited to participate in the study through the SONA research platform in the Fall 2023 semester. All study procedures will be completed through the secure Qualtrics online research platform, in addition to email and phone contacts prompting relevant steps for the study. All analyses will be run with multilevel modeling with the full intent-to-treat sample to test time by condition interactions.
The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.
A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to. The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).
The goal of this clinical trial is to test the hypothesis that combined Respiratory Muscle Training and a Stroke Wellness Program is more effective than a Stroke Wellness Program alone for stroke survivors with and without a smoking exposure history. Participants will participant in a Stroke Wellness Program consisting of strengthening, cardiovascular and flexibility training program plus respiratory exercise for 24 sessions (3x/week for 8 weeks). Researchers will compare outcomes to those randomized to a respiratory strengthening program compared to a relaxation training program to see if those who received respiratory strengthening had improved maximal respiratory pressure, improved physical activity and improved quality of life compared to those who received relaxation training.
The goal of this clinical trial is to learn about how a digital training platform can enhance implementation and effectiveness of a validated mHealth system, called FOCUS, in people with serious mental illness. The main question this research aims to answer is whether patients obtain similar outcomes to previous FOCUS studies when using FOCUS with clinicians trained on a newly developed digital training platform. Participants will be asked to use the FOCUS smartphone application and receive mobile health coaching from clinicians who have been trained using the digital training platform.
Meru Health Inc. seeks to further validate the Meru Health Program (MHP) as a single solution to screening, referral, and treatment in primary care as compared to treatment as usual using a Randomized Controlled Trial (RCT) study design. The goal of this study is to determine the feasibility, effectiveness, and implementability of this digital mental health (DMH) solution. If proven effective and implementable, more widely integrating the MHP into primary care has the potential to improve the systems of screening, referral, and treatment for depression nationwide. This, in turn, will serve as a solution to improve access to effective care for the millions of Americans currently suffering from depression, ultimately reducing its public health burden.
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.
The primary objective of this study is to evaluate clinical outcomes among people with cancer who participate in a 12-week therapist-supported digital mental health intervention (DMHI) called the Meru Health Program (MHP). Study participants (N=20) will be referred to the MHP through the Cancer Support Community (CSC) Helpline and network of Gilda's Club locations. The main outcomes will be depression symptoms, anxiety symptoms, health-related quality of life (HRQoL), intervention adherence, and intervention satisfaction. The secondary objective will be to determine the acceptability of the screening and referral process from the CSC networks into the MHP. Data pertaining to implementability will be collected from study participants, MHP clinicians, and CSC staff.
This trial studies how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.
Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).
This is a validation study to evaluate the acceptability, feasibility and preliminary efficacy of the Brain Health Program, a multimodal curriculum covering dementia risk factors and evidence-based change interventions. The goal of this study is to evaluate the Brain Health Program in individuals with identified risk factors for the onset of dementia and to prepare for a large-scale efficacy trial in this population.
This is a 2-arm group-randomized hybrid effectiveness-implementation (HEI type 2) study to test an evidence-based intervention (EBI) known as Stand \& Move at Work(SMW) to reduce sedentary time in the workplace, and to test the role of expert facilitation (SMW+) for improving intervention fidelity.
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use. The investigators will be evaluating if the addition of a pain coach/councilor before and after surgery, through a tele health platform (LucidLane) can improve participant's recovery from major joint surgery.
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.
Program studying the number of steps post-operative patients need to take to prevent post-operative complications. Also studying surgical resident wellness program that provides extra time to ambulate with inpatients.
Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.
A pilot study titled "A Virtual Cardiometabolic Health Program for African Immigrants (The Afro-DPP Program) will be conducted to address the cardiometabolic of community-dwelling African immigrants who have multiple cardiometabolic risk factors including hypertension, Type 2 Diabetes, high cholesterol, and overweight/obesity. The proposed study will recruit a total of 60 participants and will use a non-equivalent control group design to test the effectiveness of the intervention at two African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly assigned to the intervention or delayed intervention group. At the end of a 6-month follow-up period, the control church will receive the intervention (delayed control group). All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body composition including Body Weight, Body Fat percentage, Visceral Fat, Skeletal Muscle percentage, Resting Metabolism and Body Mass Index. A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will also be distributed to all participants. All participants will download the Omron Connect app which will allow the participants to sync participants' blood pressure readings and body composition readings into the app. The research team will access these readings to monitor study outcomes and participants progress during the follow-up period.
Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.
About 11% of the U.S. older adult population is at risk for or suffers from subjective cognitive decline. While some factors such as genetics and habitual physiological changes that affect brain health cannot be changed, research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress and diet can help to delay or reduce cognitive decline. Yet few brain health promotion programs exist and those that do fail to focus on global health and wellness as a strategy to improve brain health. Wits Workout is a holistic, 12-session, 60-minute per session, multi-modal workshop series that offers adults ages 50 and older facilitated, interactive dialogue and activities about behaviors that promote brain health. Each week includes a different themed module which has four activities and a training component.
This is a research study, designed to test and create new ideas that other people can use. The purpose of this research study is to evaluate two ways of helping people learn to keep their brain healthy. Research has shown that things like exercise, diet, and computer-based cognitive training (doing things that make you think and remember on a computer or tablet) may help older persons maintain their mental functioning as they get older. We want to look at two ways for people to a develop brain healthy lifestyle that they can use and even enjoy. If we find that one of the ways of developing a brain healthy lifestyle is better than the other, other older persons may be able to use it, too. When we say "brain healthy lifestyle," we mean doing things that help to keep you healthy, like exercising and following a good diet. We also mean doing things that may help you think better and maintain your thinking and reasoning as you get older.