Clinical Research Directory

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Tobacco use remains the leading cause of death in the United States and contributes to more than 7 million hospitalizations annually. Being admitted to the hospital offers the perfect opportunity to support smoking cessation. Patients are motivated to quit because of their current illness and societal guidelines recommend clinicians should counsel patients and prescribe smoking cessation pharmacotherapy (SCP) to virtually all smokers. However, only 22% of patients are prescribed SCP while hospitalized, and only 1% are prescribed medications compatible with current guidelines. This failure is part of the reason 70-80% of hospitalized smokers eventually relapse. The relapse typically occurs within a few days of hospital discharge - well before outpatient follow-up can occur. The investigators aim to improve smoking cessation treatment and guideline adherence by utilizing the opportunity that hospitalization provides. The investigators have created a tobacco treatment team (T3) to overcome physicians' and patients' low use of current guideline smoking cessation medications. The team members are trained in tobacco treatment and will be led by a nurse practitioner (NPT3). The team will work together and 1) prescribe individually tailored and guideline-concordant SCP; 2) counsel and motivate patients to use SCP properly; and 3) manage a mobile phone-based text-messaging system to keep patients motivated and adherent to SCP. Our preliminary data suggest that such an approach is workable and acceptable to patients, physicians, and hospital administrators. The investigators will recruit 424 patients in the hospital who smoke with cardiopulmonary disease. These patients will be randomized to receive either usual care or personalized care with the NPT3 team. The investigators will compare rates of guideline-concordant SCP use at 1 week and exhaled carbon monoxide (eCO) verified smoking cessation at 6 months between patients randomized to the NPT3 team vs. usual care. The investigators will also measure the project's economic value from a hospital and payer perspective. Understanding the economic value will better inform hospital and insurance policies and sustainability. Finally, acceptability, generalizability, and sustainability measures will be assessed through qualitative interviews with patients, providers, and hospital leadership.

Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes

Title: Continuous glucose monitoring vs point of care glucose measurements for in-hospital type 2 diabetes management - STENO In-Hospital CGM Trial - a multisite, randomized controlled trial. Aim To investigate the effects and feasibility of continuous glucose monitoring (CGM) on in-hospital glycemic and clinical outcomes in hospitalized, non-intensive care unit (non-ICU) patients with type 2 diabetes compared to standard point-of-care (POC) glucose testing. Population: Non-ICU adults with type 2 diabetes at the participating departments at hospitals in the Capital Region of Denmark. Design: Investigator-initiated, multi-site, two-armed, prospective, randomized, open-labelled blinded endpoint (PROBE) trial. Participants are randomized 1:1 to either a POC-arm (control) or a CGM-arm (intervention): * POC-arm (control): Participants in this arm are monitored with standard of care POC-based glucose monitoring and treated with insulin according to national guidelines. Blinded CGM is applied. * CGM-arm (intervention): Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration. In the CGM-arm, a diabetes support team assists in insulin titration to ensure the execution of algorithmic decisions according to protocol. In the POC-arm the same diabetes support team will ensure that participants are treated with insulin according to national guidelines. Objectives: To compare in-hospital glycemic control and clinical outcomes between the POC- and CGM-arm participants. Outcomes: Time in range (3.9-10.0 mmol/L) and in-hospital complications are the primary outcomes. Additional secondary glycemic outcomes are reported in alignment with the newest consensus on CGM-metrics for in-hospital glucose management. Key secondary clinical outcomes are length of stay, 7-, 30-, 60-, and 90-days mortality and readmission rates after discharge. Tertiary outcomes are net costs of the two methods for handling in-hospital diabetes, and an assessment of potential heterogeneity of treatment effects from CGM compared to POC. Method: POC glucose measurements are transmitted to the Electronic Medical Record (Sundhedsplatformen). CGM data from the Dexcom G7 is transmitted to a separate web-based platform, Dexcom CLARITY, for retrospective review. Additionally, real-time glucose data from the Dexcom G7 is displayed on tablets/iPhones at diabetes support team stations for ongoing monitoring. Investigational device: Dexcom G7 CGM (Dexcom Inc., San Diego, USA). Time schedule: Inclusion Q2 2025 to Q4 2026.

Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients

Conventional in-hospital mobility programs are challenging to deliver to hospitalized infected patients (e.g., COVID-19) due to infection risk to staff, staffing shortages, and potential exposure of other patients. This study evaluates a tele-exergame mobility program, a self-administered, game-based exercise intervention guided by foot-worn sensors and step-by-step interactive guidance on a tablet. The platform promotes strength, balance, and flexibility while enhancing patient motivation and engagement through cognitively demanding gamified tasks, with remote supervision and no to minimum direct physical contact.