Clinical Research Directory

Effects of Baduanjin Exercise on Improving Health in Sedentary Young and Middle-Aged Adults

The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are: 1. Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)? 2. Does it improve their body composition, muscle strength, balance, and flexibility? 3. Does it reduce their daily sitting time? Researchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes. Participants will: 1. Be randomly assigned to one of the two groups. 2. If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks. 3. Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires.

Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial

Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral load among men living with HIV who use stimulants.

Expectant Moms Managing Attention-Deficit/ Hyperactivity Disorder

The goal of this study is to test a behavioral program for pregnant individuals with ADHD. This behavioral program focuses on skills for managing ADHD and related symptoms in pregnancy and postpartum. This pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the MomMA behavioral intervention compared to treatment as usual (TAU) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing OB workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.

CMSL Ambulatory Sensitive Condition Nudge Study 2

The project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ED) use among adult patients seen at Geisinger's Community Medicine Service Line (CMSL) clinics. The intervention occurs immediately following an appointment where a patient receives a diagnosis of an ambulatory sensitive condition (ASC; i.e., a condition considered to be a risk factor for near-term ED use). The evaluation will compare eligible patients with an ASC who were randomly assigned to receive follow-up outreach (patient portal message and/or call) from a nurse (who was automatically prompted via the Epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. Analyses will be intent-to-treat. The primary outcome is ED use in the week (i.e., 7 days) following the appointment. We ran an earlier version of this intervention (NCT06798389). The current study is modified based on results and clinical guidance. Specifically, more conditions will be included as qualifying ASCs for enrollment. Patients under 30 will be excluded. And rather than calling all patients as in the original study, patient portal users may be contacted via the portal instead of or in addition to a phone call. Finally, in the first study, the intervention was differentially effective by age group (\<45, 45-64, 65+). Our primary analysis will be conducted separately by age group, though we will also conduct an analysis combining across age groups. We will run the study until we reach at least 4,330 patients in each of the following age groups: patients aged 30-45, patients aged 45-64, patients aged 65+. Therefore, our estimated sample size is at least 4,330x3 = 12,990. We may be required to do an interim data pull and/or stop the study early at the direction of clinical or operational leaders.

Feasibility Study of a Behavioral Parent Intervention to Support Self-management in Pediatric Typ 1 Diabetes

This study investigates feasibility and preliminary effects of a new behavioral parent intervention that aims to support and improve pediatric diabetes self-management

Research on Optimizing the Use of Technology With Education

Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.

Integrated Telemedicine Program Evaluation

This project will evaluate a virtual, on-demand telemedicine program for High emergency department (ED) utilizers with comorbid physical health conditions and behavioral health correlates. Researchers will randomize patients to have either full access to the full intervention (treatment group) or to receive only standard care (control group). Analyses will be intent-to-treat. The primary outcome is the number of ED visits 120 days after the first Best Practice Alert (BPA) firing. The research team plans to enroll 3200 patients in this study. However, randomization may end due to system constraints on December 31, 2025 before reaching that target. This sample provides 80% power to detect a 35% relative reduction in ED utilization using a two-tailed test with an alpha of .15, assuming 40% compliance with the program.

A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence

This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.

Preventing Cognitive Decline: The CITA GO-ON Multi-domain Intervention Study

The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement. The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls. Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve. This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes). The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization. GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.