Treatment Trials

519 Clinical Trials for Various Conditions

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COMPLETED
Coronavirus Disease of 2019 (COVID-19) Health Education Initiative for School Safety
Description

The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.

Conditions
COMPLETED
Lifestyle Medicine Health Education and Intervention Program "Family Central E-Health"
Description

Participants will receive text messages at intervals set by preference but at least 2 times per week relating to Lifestyle Health Education for 6 months. The topics to be reviewed include: Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection. Participants will be asked to complete surveys regarding these topics at the beginning and end of the week; in addition, participants will self report to the study team vital signs (including blood pressure, blood glucose, total cholesterol, waist circumference, and body mass index (BMI)) at the beginning and end of the study. Although there is a chance participants may encounter some issues with the study procedures (possible breach of confidentiality, or issues with the study procedures), these risks are minimal. The study team will always keep information secure, and participants may decline to participate in any study procedures, or withdraw from the study, at any time. One benefit from this study may be that participants may improve their overall health by learning more about healthy eating, improved physical activity, limiting/avoiding tobacco intake, improved sleep patterns, adequate stress management, and better social connection. Participation in this study is not required.

RECRUITING
Continuous Glucose Monitoring in Prediabetes with Health Education Videos
Description

The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.

Conditions
RECRUITING
A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York
Description

This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.

Conditions
COMPLETED
Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women
Description

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.

NOT_YET_RECRUITING
Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
Description

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are: * What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group? * What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system. 4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.

Conditions
COMPLETED
Predict + Protect Study: Exploring the Effectiveness of a Predictive Health Education Intervention on the Adoption of Protective Behaviors Related to ILI
Description

The goal of this prospective, digital randomized controlled trial is to evaluate the effectiveness of a predictive ILI detection algorithm and associated alerts during influenza season for adults living in the contigent United States. The main study objectives are to assess the effectiveness of predictive ILI detection algorithm and associated alerts on protective behaviors related to ILI and assess the accuracy of a predictive ILI detection algorithm using participant self-reported ILI symptoms and diagnosis.

RECRUITING
Health Education Approach to Lung Screening
Description

Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

Conditions
ACTIVE_NOT_RECRUITING
Movement-Based Pelvic Health Education for Women in Underserved Communities
Description

It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.

ENROLLING_BY_INVITATION
Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study)
Description

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention. A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline. Although promising, the booster incorporated in the study needs further empirical refinement. The current project seeks to build on past progress by further developing and refining the booster. In particular, the current project is an extension of previous work by expanding the investigation into complete social networks (students involved in Greek life). This booster contains feedback about alcohol use tailored to the recipient, and will be emailed 2, 6, 10, and 14 weeks after baseline (experimental condition), or not at all (control condition). This study will be conducted specifically with students who are members of fraternities or sororities at ODU (specifically, those in the organizations that agree to participate). This population engages in heavy alcohol use so is ideal for an alcohol intervention. Members of fraternities and sororities (i.e., "Greek life") engage in more frequent drinking, consume more when drinking, and have higher peak drinking occasions than students not involved in Greek life. We aim to administer the intervention and associated booster among complete networks of Greek organizations to examine how the intervention and booster and progress through social networks.

RECRUITING
Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer
Description

This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

COMPLETED
Wellness Education Intervention
Description

Individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (HPA) axis. Though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. The impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. Here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. This project will improve our understanding of the role of mental health and the stress response in obesity.

COMPLETED
Evaluating the Impact of Vocal Health Education on Mask-wearing Workers During COVID-19
Description

The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.

Conditions
RECRUITING
Compassion Meditation vs. Health Education for Veterans
Description

Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. CP with psychological comorbidity is associated with increased healthcare costs, medication use, risk of suicide and rates of disability and reduced quality of life. Current empirically supported treatments do not always lead to substantial improvements (up to 50% of patients drop out or are do not respond to treatment). This project was designed to evaluate the efficacy of a novel intervention for addressing these challenges. Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of among Veterans with CP conditions and psychological comorbidity.

RECRUITING
War on Melanoma™ Public Health & Education Campaign
Description

This trial studies how well a health educational campaign works in increasing early detection of melanoma in Oregon. The health educational campaign may provide information to help people learn about the early signs of melanoma. Increased education in Oregon may decrease the number of people who die from melanoma and increase the number of melanomas that are identified at an earlier stage.

Conditions
COMPLETED
Timing Personalized Feedback After Alcohol Health Education
Description

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman \& Henson, 2016). A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline (Braitman \& Lau-Barraco, 2018). Although promising, the booster incorporated in the study needs further empirical refinement. The current project seeks to build on past progress by further developing and refining the booster. In particular, to identify the most efficacious timing for sending the feedback. The content will be similar across conditions, but will be disseminated at different times to identify the most impactful timeline. There will be 6 study conditions: those who receive the emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at all (control). Thus, the aim of the current study is to identify optimal timing for sending the tailored booster feedback via booster email.

TERMINATED
Arts & Health Education to Improve Health, Resilience, and Well-Being
Description

This is an 8-week randomized controlled trial to help address health, resilience, and well-being. Participants are randomized into either a health education group or an arts-based health education group. Both groups will attend for 8 weeks and various study assessments will be conducted in order to measure the experience and impact of the program. Anyone 18 years and older with a chronic health condition (for example, diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disorder, asthma, weight, anxiety, depression, cardiac, arthritis, multiple sclerosis, and many more) are eligible to participate.

TERMINATED
Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
Description

Teens with ASD ages 14-19 will be screened for eligibility, complete a baseline interviewer/ACASI-administered survey, and randomly assigned to either intervention or control group. The enrollment goal is 500 teens. The 12-hour intervention will be run in groups of up to 12 teens, with health educators leading the group and actors assisting, role playing with participants, and performing a skit. Teens in the intervention group will take a post satisfaction survey, and teens in both conditions will take a 6-month and 12-month interviewer/ACASI-administered outcome survey. Fidelity will be monitored by observers and rated by health educators.

ACTIVE_NOT_RECRUITING
Evaluation of Health Education Theater
Description

This study evaluates the feasibility and the potential positive health impacts of a novel "health education theater," which will task participants of a health education program to create an original 10-minute theater that is required to use the health guidelines about physical activity and diet/nutrition. The outcomes include the changes in (a) knowledge about these guidelines, (b) compliance to these guidelines, (c) health related quality of life, and (d) self-perception well-being measures such as self-esteem and self-efficacy.

TERMINATED
Tai Chi and Wellness Education for Older Veterans
Description

The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in comparison to a wellness education attention control. Secondary outcomes include physical activity, depression, well-being, late-onset stress, functional status, cognition, and exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison to the control condition.

COMPLETED
Personalized Booster Feedback After Alcohol Health Education
Description

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman \& Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. The current project seeks to build on past progress by further developing and refining the booster. In particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual. There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect. Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.

COMPLETED
Alcohol Health Education With Personalized Feedback Boosters
Description

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman \& Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely available. The current project seeks to build on past progress by further developing and refining the booster. In addition, it examines the utility of the booster after a different, widely-used, empirically-supported online intervention (e-checkup to go). e-checkup to go directly provides personalized normative feedback, but not protective strategies, the two components of the examined booster. Hence, the current study compares the reinforcing content (normative feedback) to the combination of reinforcing and novel content (norms PLUS protective strategies). There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 does not receive a booster email. Condition 2 receives an emailed booster with normative feedback only. Condition 3 receives an emailed booster with normative feedback plus protective strategies. The aims of the current study are as follows: Aim 1: Examine if novel feedback in the form of protective strategies enhances the reinforcing normative feedback received via booster email (i.e., a comparison of reinforcing normative feedback only versus reinforcing normative feedback plus novel protective strategy feedback). Aim 2: Examine previously identified potential moderators and mediators of reductions in alcohol use and related problems.

COMPLETED
Hormonal Contraceptive Health Education for Adolescent Males
Description

Prospective randomized control trial of an educational electronic application on female hormonal contraception for adolescent males in the pediatric emergency department.

COMPLETED
Oral Health Education Interventions Among Seniors
Description

The study aims to assess the efficacy of an oral health education group based activity versus an individual based oral health education activity in terms of changes in oral health related quality of life (OHRQoL), self-efficacy and oral health knowledge.

ACTIVE_NOT_RECRUITING
HELP-HY: Health Education and sLeep Program in HYpertension
Description

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed. In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).

COMPLETED
Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy
Description

The Specific Aims of this treatment development research are: To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education group (attention control) for persons with chronic pain who are taking methadone maintenance therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment. Participants will be enrolled in the active intervention for 3 months, and then be followed for 6 months afterwards. Investigators' aims are: 1. To assess feasibility and acceptability of both the yoga class and the health education control group. Investigators will assess credibility of the assigned intervention and expectancy for improvement for both groups at baseline, program satisfaction following program participation, participant adherence (class attendance rate and amount of home practice corresponding to assigned study arm), and instructor fidelity to the manuals. Investigators will conduct structured interviews following program participation to understand specific aspects of both programs considered attractive, useful, or not useful; we will solicit suggestions for improvements as well. 2. To assess safety, investigators will track all adverse events in a structured fashion. Investigators do not expect to see any serious adverse events definitely or probably related to study participation. 3. To assess feasibility of research procedures, investigators have benchmarks for recruitment rate, retention for study assessments, and reliability of instructor fidelity measures.

COMPLETED
Educational Impact of the NLM/National Area Health Education Center Organization (NAO) Project-SHARE Based Teen Health Information Literacy Curriculum
Description

Background: The Teen Health Information Literacy Project is an after-school program for high school students. It gives them skills to access valid and reliable health data. It also aims to grow young health advocates. Researchers want to find out more about the impact the program has had on students. They want to use this feedback to improve the program. Objective: To gain feedback about the Teen Health Information Literacy Project. Eligibility: Young people who participated in the Teen Health Information Literacy Project. The project was run by Area Health Education Centers (AHECs) and sponsored by the National Library of Medicine (NLM). Design: The study will be explained to students during a program session. They will take consent forms home to their parents. Participants will split into 6 focus groups. Each one will be conducted at an AHEC project site. The focus group will be a 90-minute discussion between participants and an evaluator from the NLM. The evaluator will be present either in person or by video conference. The evaluator will ask participants questions, which may include the following. What did they like and dislike about the program? Why did they decide to participate? What have they learned? Would they recommend this program to another student? How has the program affected their interest in health-related careers? The discussion will be audio-recorded. The evaluator will use an automated tool to convert recordings into text. After that, she will destroy the audio.

COMPLETED
Mindfulness-Based Stress Reduction, Health Education and Exercise
Description

The purpose of this research is to examine the effects of four interventions on age-related cognitive decline in healthy older adults. The investigators will examine the effects of Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based aerobic exercise, and their combination, compared to a discussion group.

COMPLETED
Sleep Health Education and Social Support Among Blacks With OSA
Description

The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.

COMPLETED
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
Description

This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.